The Promise of India’s Medical Devices Sector

Modern health care is built on a number of pillars, an important one among them comprising medical devices—ranging from simple diagnostic tools to complex AI-based imaging systems and implantable devices such as stents, advanced imaging machines, and digital health solutions. With India’s growing population, the rising incidence of chronic diseases, and increasing demand for quality health care, the medical devices industry has the potential for expansion. Currently valued at approximately US$11 billion, the sector is projected to grow into a US$50-billion industry by 2030.^[1] However, this goal can be achieved only if there is a regulatory environment that provides safety, fosters innovation, and attracts investment. India has been heavily reliant on imports for decades, with almost 70‒80 percent of its medical devices sourced from foreign companies.^[2] While efforts such as ‘Make in India’ and Atmanirbhar Bharat attempt to curb this reliance, regulatory challenges have hindered expansion.^[3]

The term ‘medical devices’, though often used interchangeably with ‘MedTech’, may not be precisely the same. Medical devices refer specifically to instruments, machines, implants or software with a defined medical purpose. Medical technology or MedTech encompasses this group as well as software platforms, diagnostic tools, remote monitoring systems, and digital therapeutics. This paper uses the term ‘medical devices’ in reference to regulatory frameworks and industry standards, whereas ‘MedTech’ is preferred when discussing innovation, convergence with digital health, and ecosystem-level growth.

Historically, medical devices were regulated in India by drugs-centric legislation under the Drugs and Cosmetics Act 1940, a pharmaceutical-favoured system, with no focus on medical technology.^[4] This approach introduced uncertainty and prolonged the approval process. It also did not confront the distinctive risk profiles of medical devices and restricted accessibility especially in the rural regions. In 2018, The Lancet’s ‘Global Burden of Disease’ study ranked India 145^th out of 195 countries for accessibility of health care. Furthermore, non-functional machinery in 35‒60 percent of infrastructure was reported across various states, many of which may not have even met the required calibration criteria.^[5],[6],[7] Medical Devices Rules (MDR) 2017 initiated the transition towards a more structured, risk-based classification system.^[8] This was supplemented in February 2020, when the government broadened the definition of ‘medical devices’, bringing nearly all categories under its regulatory purview.^[9]

The regulatory system continues to function through the Drug Controller General of India (DCGI), primarily a pharmaceutical-oriented body, leading to inefficiencies and delays in the approval of devices.^[10] Unlike the United States Food and Drug Administration (US FDA), which has a dedicated Center for Devices and Radiological Health (CDRH), India lacks specialised medical technology regulation expertise; the approval process is therefore complex, especially for new and high-risk devices.^[11],[12]

The reliance on foreign regulatory approvals is yet another challenge. Most of the high-risk Indian medical devices enter the market with assistance provided by pre-clearance from the US, Europe or other reference nations,^[a] without local clinical validation.^[13],[14] Although this pathway offers quicker access to new technology, it raises safety and efficacy concerns for the Indian population due to differences in patient populations and disease epidemiology. Conversely, countries such as China require clinical testing in the local environment even for foreign-approved products to ascertain whether imported products are within local requirements.^[15]

Post-market surveillance is also a weak link in India’s regulatory system. In contrast to the publicly accessible EUDAMED (European Database on Medical Devices) of the European Union (EU) or the US FDA’s MAUDE (Manufacturer and User Facility Device Experience) system, India does not have a publicly accessible, centralised system for reporting device failures, adverse events, and recalls.^{[16],[17],[18]} Though the Materiovigilance Programme of India (MvPI), initiated in 2015, tracks adverse events related to medical devices through a network of reporting centres operated by the Indian Pharmacopoeia Commission (IPC), its reports are not openly published.^[19] Without real-time monitoring of safety, problems will only arise after widespread patient use. Enhanced post-market surveillance is needed to build confidence in Indian-made devices.

The uncertainty in rules can also deter investors. Constant shifts in policy—for example, the unexpected price capping on coronary stents in 2017—are responsible for instability in the business environment.^[20],[21] Companies would not prefer to invest in mass-scale indigenous production when the rules keep fluctuating. A stable policy environment is essential to instil confidence in both global and Indian firms to manufacture in India. The country’s vision of turning its medical device sector into a US$50-billion industry by 2030 hinges on additional regulatory reforms. Now is the time to establish a regulatory system that is both predictable and conducive to innovation.

The system is not just determined by the laws that control approval and safety, but also by the manner in which the devices are taxed, marketed, and acquired. Procurement regimes determine whether quality devices end up at health facilities in a timely manner and at affordable prices. Price-setting mechanisms like price ceilings have an effect on investor psyche and affordability while taxation regimes like the Goods and Services Tax (GST) have a direct effect on marketability and affordability. Although these drivers are likely to be viewed as administrative or downstream, in practice, these do have a regulatory impact, shaping compliance costs, incentives to innovate, and patient access. Accordingly, this paper will also consider procurement and pricing in the wider regulatory context.

The Evolution of India’s Medical Devices Regulatory Framework

In the decades following Independence, India’s oversight on medical devices remained an appendage of drug regulation under the colonial-era Drugs and Cosmetics Act (DCA) of 1940.^[22] The Act initially lacked a clear definition of ‘medical devices’, treating them implicitly as ‘drugs’. The first attempt to regulate a device was made in 1961, when one medical device was notified for control under the DCA.^[23] It was only in 1982‒1983 that lawmakers formally amended the Act to include a definition of ‘device’, allowing specific medical devices to be notified and regulated like drugs.^[24] Even with this amendment, the regulatory system was still in its infancy, with medical devices being regulated by drug authorities without any specific regulations adapted to their unique risks and life cycles.

By the late 1980s, the government had begun to recognise the dangers from unregulated equipment and expanded the list of devices under official oversight. In March 1989, it notified three critical sterile medical devices―disposable hypodermic syringes, needles, and perfusion sets―as ‘drugs’ to bring them within regulatory control.^[25] This step, driven in part by public health concerns (such as unsafe injections and disease transmission), marked a milestone. In 1994, authorities introduced Schedule M-III to the Drugs and Cosmetics Rules, which laid down specific requirements for manufacturing medical devices.^[26],[27] This was an early attempt to address quality and safety in device production, as Schedule M-III provided standards for factory premises and processes for devices (analogous to good manufacturing practices for drugs). However, these efforts were still uneven―they covered only a handful of devices and primarily focused on manufacturing conditions, without a comprehensive framework for device design or clinical evaluation.

Throughout the late 1990s and early 2000s, India’s regulatory approach towards medical devices remained reactive and incremental. New devices were brought under regulation only in response to evident needs or risks. In 2002, for instance, four in vitro diagnostic (IVD) test kits (for HIV, hepatitis B and C, and blood typing) were notified for the first time.^[28],[29] This step was taken amid rising concerns about blood safety and the quality of diagnostic tools. Similarly, in October 2005, the Ministry of Health and Family Welfare (MoHFW) moved to regulate 10 more categories of medical devices―mostly life-saving or high-risk products like cardiac stents (including drug-eluting stents), heart valves, intraocular lenses, catheters, bone cements, orthopaedic implants, intravenous cannulae, scalp vein sets, and other internal prosthetic replacements. With this expansion, by 2005, India had around a dozen medical devices officially under regulation.^[30] Yet this was a small fraction of the devices in use. Numerous common devices, from insulin pumps and glucometers to surgical tools, remained outside the scope of any mandatory standards. The piecemeal character of reforms meant that the regulation trailed behind the technology; machines (some of them invasive) could be sold with no pre-authorisation or quality examination, leaving critical safety issues unaddressed.

There was a growing consensus that the Drugs and Cosmetics Act regime was inadequate for the medical devices sector.^[31] The limitations of treating devices as drugs, without risk-based classification, device-specific standards or robust post-market vigilance, had become increasingly apparent. In 2016, as a stopgap measure, the authorities updated Schedule M-III (Quality Management Systems) to align domestic manufacturing requirements with international quality standards (like ISO 13485).^[32] The update aimed to improve device quality control by addressing gaps in the 1994 version of Schedule M-III, which had failed to keep pace with modern manufacturing and design controls.

The real turning point came with the notification of Medical Devices Rules 2017 (MDR 2017) on 31 January 2017.^[33] Coming into effect on 1 January 2018, MDR 2017 was India’s first set of regulations dedicated exclusively to medical devices, formulated under the umbrella of the DCA but separate from drug regulations. Recognising that medical devices required a distinct regulatory approach, this new framework was a crucial first step in moving away from the previous decades of one-size-fits-all, drugs-centric regulation.

Under MDR 2017, a host of long-needed changes were introduced: a risk-based classification system (Class A for low risk through Class D for high risk) to tailor requirements proportionately; clearer procedures for device licensing; and stronger emphasis on quality management and conformity assessment specific to devices.^[34] For example, device manufacturers now had to obtain certifications and licences based on this risk class while clinical investigations for devices were governed by dedicated rules (separate from pharmaceutical clinical trial norms).

The rules also formalised post-market requirements such as adverse event reporting and recall provisions, which had been absent or inconsistent in the previous framework. In short, MDR 2017 began to fill many of the regulatory gaps―it provided regulators with more direct oversight of devices “on a standalone basis” and acknowledged that devices and drugs are fundamentally different categories.^[35]

Crucially, the rules initially applied only to those devices notified by the government as of that date―around 15‒22 devices, depending on categorisation.^[36] This meant that the old piecemeal approach lingered, and any device not on the notified list was still technically unregulated by the Central Drugs Standard Control Organisation (CDSCO). Recognising this limitation, regulators pressed on with expanding the list. In late 2018, the authorities added commonly used devices like nebulisers, blood pressure monitors, digital thermometers, and glucometers to the notified list.^[37] Further notifications in early 2019 covered additional implants and equipment.^[38] Yet, even with these additions, by 2019, only a few dozen device types were under regulation, out of thousands in the market.

Needless to say, the approach to notifying devices one by one was too slow and left dangerous regulatory blind spots. A landmark change happened in 2020: The Ministry of Health and Family Welfare (MoHFW) issued a new, expansive definition of ‘medical device’ under the DCA, effective 1 April 2020, that essentially brought all devices under regulation. The notification S.O. 648(E) (dated 11.02.2020) defined ‘medical devices’ in broad terms: covering any instrument, apparatus, implant, material or software intended for diagnosis, prevention, monitoring, treatment or other health-related purposes (and that does not primarily act through pharmacological or immunological means).^[39]

In one sweep, this catch-all definition closed the loophole that had allowed many products to operate in a legal vacuum. Manufacturers and importers of previously unregulated devices were given a transition period to register and comply with the MDR 2017 requirements. The significance of this 2020 reform simply cannot be overstated: it moved India away from the prior “notify to regulate” model to near-universal coverage of medical devices.^[40] The expansion was overdue in bringing in the much-needed regulation, but it also called for a more formalised regime of price control, an area that comes under the jurisdiction of the National Pharmaceutical Pricing Authority (NPPA).^[41]

The NPPA, which was initially established in 1997 to regulate drug prices through the Drugs (Prices Control) Order (DPCO), was now tasked with ensuring price stability and affordability of medical devices under the expanded regulatory umbrella.^[42] Before 2020, there were just 24 classes of medical devices that were regulated as drugs; out of them, only four—cardiac stents, drug-eluting stents, condoms, and intrauterine devices (Cu-T)—were under direct price control.^[43] The 2020 regulation that brought all medical devices under regulatory oversight also empowered the NPPA to control their pricing by capping maximum retail price (MRP) hikes at 10 percent within any 12-month period. If this threshold was breached, firms were asked to roll back price hikes to comply with the limit for the following year.^[44]

The NPPA’s price ceilings have yielded positive outcomes, though not without triggering some unintended challenges. For example, the 2017 price control for orthopaedic knee implants reduced their costs by a significant amount, making joint replacement more affordable for the average patient. However, hospitals reacted by changing other aspects of treatment costs. Therefore, while implants became less expensive, overall costs of knee replacement surgeries did not decrease proportionally.^[45],[46] This raised questions about whether price regulation alone, without corresponding controls on hospital rates, can truly make medical care more affordable for patients.

With an understanding of these issues, the NPPA has been attempting to build a distinctive, device-specific system of prices, independent from the pharmaceutical price control paradigm, which tends to overlook the distinctive cost structures and innovation cycles of medical technology.^[47] While price caps can make medical devices affordable, striking a balance between keeping prices consumer-friendly and fostering a much-needed investment-friendly environment for domestic manufacturers and global MedTech companies remains a delicate challenge. This could be instrumental in building a culture of innovation for India’s MedTech industry.

Post-MDR Challenges

Historically, India did not have a vigorous system for monitoring adverse events or device performance in the field. The Materiovigilance Programme of India (MvPI) was a step towards structured post-market surveillance. However, it remains in the nascent stages. Experts have noted that the post-marketing vigilance system for medical devices in India “is not as vigorous as” that for drugs.^[48] Analysis further detects persistent issues: few recall events, compared with thousands per year reported in Canada and Australia, and lack of clear guidelines and public availability of data limit its impact.^[49] This means that mechanisms to systematically collect data on device malfunctions or patient harms are still being developed.

After nearly a decade, the MvPI expanded from 40 reported adverse events in 2015 to 897 in 2019 and more than 7,000 cumulative reports in 2022.^[50]  Since 2018, the Indian Pharmacopoeia Commission (IPC) has served as the National Coordination Centre (NCC) for MvPI, overseeing its implementation. The programme currently functions through 150 medical device adverse event monitoring centres across the country through standardised reporting forms and helplines. However, evaluations suggest that it remains underdeveloped.^[51]

The quality management aspect has also required adjustment. Under the new rules, device manufacturers must implement robust quality systems (aligned with ISO 13485 via Schedule M-III). However, many smaller manufacturers initially struggled to meet these standards and regulators faced a steep learning curve in auditing diverse medical technologies.^[52] The CDSCO and state FDAs had to train personnel and develop expertise in device-specific inspections, a process that remains uneven across India.^[53]

In 2019, government think tank NITI Aayog proposed a new comprehensive law and creation of a dedicated Medical Devices Administration, separate from the drug regulator. One reason cited was that the existing CDSCO and the DCGI “may not have the relevant expertise” to effectively oversee the gamut of medical devices.^[54],[55] Although this proposal has not translated into a standalone agency yet, it reflects a recognition of the need for greater capacity-building and, perhaps, structural changes.

Safety Incidents

The Johnson & Johnson (J&J) articular surface replacement (ASR) hip implant fiasco is one of the most cited cases.^[56] In the mid-2000s, J&J’s DePuy unit began marketing metal-on-metal hip replacement implants in India. At that time, only a minimal regulatory review was required; the implants were treated as drugs under the Act and J&J obtained an import licence in 2006.^[57] Unknown to Indian regulators and patients, other countries were raising red flags about these devices due to high failure rates and serious side-effects (metal debris causing tissue damage).

Australia’s drug agency, for example, noticed excessive failure of the ASR hip implant in 2007 and withdrew it by 2009, and J&J issued a global recall of the product in August 2010.^[58] In India, however, the response was slow. There was no active post-market surveillance to flag the issue. Only when an orthopaedic surgeon in Maharashtra filed a complaint (and an investigative journalist’s report brought it to light) did the Indian authorities spring into action. The Maharashtra FDA lodged a formal police complaint in 2011 and the CDSCO finally moved to cancel J&J’s import licence for the hip implant in April 2012―three years after countries like Australia had banned it. An official recall notice in India was issued in late 2013, by which time hundreds of patients had received the faulty implants.^[59]

The aftermath exposed how ill-prepared the system was for device failures. There was no patient registry to track who received the implant and companies were not mandated to proactively inform all patients. Authorities had to resort to announcements in newspapers to try to reach affected individuals. As a result, roughly 76 percent of the patients who received these implants in India were not tracked at all; they did not receive timely follow-up or compensation.^[60] Many suffered needlessly and those who did come forward faced an uphill battle for remediation.

Another catalyst for change was the global investigation known as the “Implant Files”. In 2018, the International Consortium of Investigative Journalists (ICIJ) published the Implant Files, an exposé of serious flaws in medical device safety worldwide. It revealed how lax oversight and uneven regulations in many countries (including India) allowed unsafe devices to proliferate. The Implant Files highlighted India’s patchwork regulatory system as a concern, noting that devices could reach patients with little clinical evaluation, if at all.^[61] In the following months, India did beef up its medical device regulation, expanding the list of devices subject to strict oversight.

New Policies and Persistent Systemic Gaps

The government has put forth two policy proposals: the National Medical Devices Policy 2023 and the Draft New Drugs, Medical Devices, and Cosmetics Bill 2022 to address systemic weaknesses and create an investor-friendly environment. The National Medical Devices Policy 2023 identifies medical devices as anything but drugs; what they require is a regulatory framework that caters for the cycle of innovation and market forces. It involves streamlining approvals, de-bureaucratisation, and implementing a single-window clearance system to facilitate quick regulatory clearances.^[62] This is an important change since India's previous practice of regulating devices according to pharmaceutical laws has led to inefficiencies.

The Policy also aims to increase India's share in the global medical devices market from its current 1.5 percent to 10‒12 percent over the next 25 years.^[63] Yet, while the policy sets ambitious production and research targets to drive scale, it remains more of an industrial development policy than a comprehensive regulatory overhaul. Instead of creating a level regulatory playing field, it seeks to establish capability to manufacture and invest in private sector investment.

The Draft New Drugs, Medical Devices, and Cosmetics Bill 2022 is a regulation-heavy proposal intended to replace the outdated Drugs and Cosmetics Act (DCA). The draft Bill acknowledges the failure of India's earlier regulatory approach wherein medical devices were classified as drugs. One of the most interesting aspects of the Bill is the institutionalisation of a Medical Device Technical Advisory Board (MDTAB), an initiative that, if executed well, can mobilise specialist knowledge to the regulation system and move the science-based evaluation of devices forward.^[64] Second, the Bill lays down more stringent post-market surveillance systems so that the model in India is on par with the world's best practices. The most significant change in the draft Bill is that it accords priority to clinical trials and evidence-based approval of medical devices.^[65]

India has historically relied on foreign regulatory approvals to accelerate market introduction of high-risk devices.^[66] The new Bill reflects a willingness to improve local conditions for testing, with possible local clinical testing of high-risk devices before market clearance. However, India's regulatory ability in this sector remains underdeveloped. Without enormous investments in testing and evaluation centres, the functioning of this provision will tend to create bottlenecks.

A shortcoming of the Policy and the draft Bill is that there is no independent regulatory agency with a mandate for medical devices, such as the US FDA’s CDRH. While the new MDTAB is a welcome development, a single-function agency, however, would provide long-term guarantee and ensure that medical devices are evaluated by individuals with extensive sectoral experience. Further, while both proposals advocate for stronger post-market surveillance and quality control, neither currently establishes an integrated, publicly accessible safety database.

The proposals also do not provide clarity on software as a medical device (SaMD) or refurbished medical devices.^[67] However, the CDSCO has taken a leap towards implementing the International Medical Device Regulators Forum’s (IMDRF) risk-based classification for SaMDs (Classes A to D), along with adherence to safety, labelling, regulatory filing, and AI-specific considerations like data availability, security, and change management principles. Still, sophisticated implementation channels for AI/ML-based products do not exist in India’s regulations. As comparative studies demonstrate, while the US and the EU are establishing formalised oversight for real-world evidence, transparency, and machine learning models, India's regulatory framework remains constrained by limited institutional experience and capacity to scale these principles.^[68]

Global Practices: India Vs. the US, Japan, and the EU

The comparative analysis herein is centred on the US, the European Union (EU), and Japan, alongside India, due to their outsized impact on the global trade on medical devices, as well as their standards and regulation. The three markets combined represent a large share of global MedTech imports and exports, establishing de facto international norms in safety, efficacy, and innovation channels. Regulatory decisions by the US FDA also serve as a global benchmark while Conformite Europeenne (CE) in Europe facilitates relatively straightforward access to some national markets within the region. Japan, the world's second largest MedTech market, provides a pointer to high regulation, high innovation economies. These governments are also leading reference markets for Indian approvals for regulation and trade, with a large number of Indian manufacturers required to comply with their standards or seek entry into these geographies. The choice thus reflects both their global market dominance as well as their regulatory significance to India’s emerging domestic system.

The aim of this exercise in comparison is twofold: first, to make an assessment of how India’s existing system of regulation matches or varies with international best practices; and second, to learn lessons that can guide India towards a more stable, innovation-led, and internationally competitive system of regulation. Such comparisons also define the trade-related implications of regulatory mismatch, wherein non-harmonisation can strangle exports, hold up approvals, or drain investor confidence.

Risk-Based Classification

India’s regulatory framework classifies the devices into Class A, B, C, D (low to high risk).^[69] This four-tier system mirrors international practice, adopted from the IMDRF.^[70] In contrast, the US FDA uses Class I, II, III (three tiers, from lowest to highest risk). Similarly, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has Classes I‒IV (IV being highest risk) while the EU MDR employs Class I, IIa, IIb, and III categories.^{[71],[72],[73]} All these systems are risk-proportionate, but the nomenclature and number of levels differ.

Pre-Market Approval and Clinical Evidence

Regulatory pathways vary. India requires CDSCO registration for all but the lowest-risk devices, with Class A/B devices subject to a simpler process (often licensed with basic documentation) and Class C/D (higher risk) needing full evaluation.^[74] Notably, India recognises predicate devices (if an equivalent device is already approved in India) to streamline clearance, conceptually like the US 510(k) system.^[75] The US FDA mandates pre-market notification [510(k)] for most Class II devices (by demonstrating substantial equivalence to a predicate) and pre-market approval (PMA) with rigorous clinical trial data for Class III devices. Many low-risk Class I devices in the US are exempt from pre-market review altogether.^[76]

Japan uses a mixed approach: Class I devices only require a notification (no review); certain moderate-risk devices can go through third-party certification (if standards exist); and Class III/IV (highly controlled) devices need full PMDA review and approval (known as Shonin).^[77] The EU (under MDR 2017/745) employs conformity assessments instead of a single authority approval. Low-risk Class I devices are self-certified while higher classes require notified body assessment for CE marking. The EU demands robust clinical evidence proportional to risk: even moderate devices need clinical evaluation reports and implants/high-risk devices often require clinical investigations.^[78]

In India, clinical evidence requirements have been relatively flexible for lower-risk and imported devices. For instance, imported Class A/B devices can be approved with existing literature and a free-sale certificate in lieu of local trials, whereas new high-risk devices (Class D) typically require local clinical investigations before approval.^[79] Overall, the US and the EU require more stringent pre-market clinical data for high-risk products. India’s nascent system is evolving towards similar rigour but still allows expedited paths for devices that have already been vetted abroad.

Post-Market Surveillance and Reporting of Adverse Events

India launched the MvPI to monitor device safety, requiring manufacturers to report adverse events to authorities. However, India lacks a publicly accessible incident database―there is no centralised public adverse event registry as of now.^[80] In contrast, the US has a well-established mandatory reporting system―Medical Device Reporting (MDR)―and a public adverse event database (MAUDE), which is openly searchable and updated monthly. The EU’s MDR introduced stricter post-market surveillance, including periodic safety update reports (PSURs) and a centralised database EUDAMED for vigilance. Once fully implemented, EUDAMED will publish safety alerts and incident reports for public access. Japan requires manufacturers to report malfunctions and adverse events (Fuguai) to the PMDA. Safety information (recalls, field corrections) is published in safety communications, though Japan does not yet offer a MAUDE-like comprehensive public database in English.^[81]

Harmonisation with International Standards

India’s 2017 rules explicitly drew on the Global Harmonisation Task Force (GHTF/IMDRF) principles, with its risk classification rules based on the IMDRF’s model. Regulators accept internationally recognised standards [e.g. a quality management system certificate (QMS) per ISO 13485 is required for device registrations].^[82] India also plans to implement Unique Device Identification (UDI) in line with the US/EU systems. Though the rollout has been indefinitely delayed, a final notification, issued on 31 December 2021, amended Rule 46 of MDR 2017, postponing the original 1 January 2022 deadline; new timelines are yet to be announced by the Ministry of Health and Family Welfare.

As of 2025, there are indications of a Phase 1 rollout for high-risk devices under discussion, however, no publicly available documentation or formal guidance has been issued to confirm this.^[83] The US historically had unique requirements [e.g. the FDA’s Quality System Regulation (QSR)] but is now harmonising. The FDA has finalised a rule to replace its QSR with ISO 13485 QMS requirements by 2026, a significant step aligning with the global standard.^[84] The FDA, the EU, and Japan all participate in the IMDRF and programmes like the Medical Device Single Audit Programme (MDSAP), which uses ISO 13485 audits across jurisdictions.^[85]

Predictability and FDI in MedTech

Regulatory predictability is a key factor in attracting foreign direct investment (FDI). Global MedTech companies would likely prefer markets where approval timelines, requirements, and enforcement are consistent. The US and the EU, despite their high standards, offer that predictability―the rules rarely change overnight and there are established pathways for innovation (e.g. the FDA’s Breakthrough Device Programme, the EU’s guidance documents), boosting investors’ confidence in product development planning.^[86] Similarly, Japan provides a stable regulatory timeline and its recent moves to expedite digital devices (Digital Transformation Action Strategies in Healthcare/DASH for Software as a Medical Device/SaMD) show responsiveness without unpredictability.^[87]

Historically, India’s regulatory uncertainty deterred some FDI―companies saw higher risk in unclear rules or protracted licensing processes. Anecdotally, gaining device approval in India was sometimes seen as slower or less transparent than obtaining a CE mark or 510(k). This uncertainty, coupled with a small market size, meant fewer foreign players setting up manufacturing, even though India allows 100 percent FDI in medical device manufacturing under the automatic route.^[88],[89]

Regulation of Software as a Medical Device (SaMD)

The US treats SaMD according to risk under its existing device laws, with many clinical decision support software and artificial intelligence (AI) diagnostics regulated as Class II or III devices. The FDA clears or approves SaMD via the same pathways as hardware: e.g. an algorithm for detecting arrhythmias may get 510(k) clearance if it is similar to an existing device, whereas a novel AI diagnosing a critical condition may require a PMA or De Novo review. Recognising the unique challenges of software (like frequent updates and machine learning), the FDA has issued guidance and discussion papers proposing a “total product lifecycle” framework for AI/ML-based SaMD while it piloted the Digital Health Pre-certification (Pre-Cert) programme to evaluate manufacturers’ software quality processes in lieu of case-by-case review.^[90] While Pre-Cert is not yet an official pathway, it reflects the FDA’s innovative approach.

Japan formally brought SaMD under regulation in 2014, classifying standalone software as medical devices when intended for diagnosis and treatment. The PMDA has since approved various AI-based devices. Japan acknowledged it was lagging in digital health adoption while the US had been approving five times more AI/ML SaMD products in recent years. To close this gap, Japan launched the DASH initiative in 2020 and in 2021, it created a dedicated SaMD review office. These steps streamline SaMD approvals and provide guidance to developers, accelerating product commercialisation.^[91],[92] Japan’s regulators also participate in the IMDRF’s work on SaMD risk categorisation, aiming for international consistency.

The EU, under the MDR, does not have a separate track for SaMD but includes software in its device definition and has tightened rules for software classification. MDR Rule 11 essentially up-classifies most medical software: if software drives clinical decisions, it is classified at least as Class IIa, with higher classes assigned if potential patient harm is more serious.^[93] This means many AI diagnostic apps in Europe now require notified body oversight and robust clinical evidence.

India’s current regulatory framework only implicitly covers SaMD and it is not yet fully equipped for the fast-evolving digital health space. The definition of ‘medical device’ in Indian law can include software if it is intended for medical purposes, meaning, in principle, a standalone clinical software can be regulated. In practice, however, India has no specific SaMD guidelines or classification rules distinct from those for general devices.^[94] Most software-enabled products in India have been those embedded in hardware or accompanying a physical device. There is as yet no Indian equivalent of the FDA’s digital health initiatives or a tailored pathway for AI-based tools. This lack of a clear SaMD pathway could become a regulatory bottleneck as domestic health tech startups proliferate and global AI devices enter India.

India should update its clinical evidence requirements to address AI/ML characteristics―for example, guidance on validating algorithms using retrospective data and prospective trials, and requirements for continuous performance monitoring (since AI can evolve). Given that the US, the EU, and Japan are converging on stricter oversight of AI in health care, India risks falling behind if it does not modernise its approach. Therefore, India’s framework must evolve to be future-ready for SaMD.

Overall, the comparison indicates that India has moved in the correct direction, especially with the MDR; however, gaps remain in post-market surveillance, regulation of SaMD, and harmonised clinical approval routes. Persistent uncertainty and partial alignment with global systems may inhibit India's ability to expand exports or gain high-quality foreign direct investment. Concurrently, India's internal regulatory reform has to be tailored to local conditions and not transplanted wholesale from abroad. Phased, context-specific introduction of best practices, i.e. more stringent SaMD regulations, public safety registries, and judicious fast-track clearances, can allow India to close the innovation gap without compromising patient safety or trade competitiveness.

The Weak Link: Public Procurement of Medical Devices

Regulation alone is not adequate to ensure effective or affordable distribution of medical devices to patients. Even the most stringently tested devices may experience underutilisation or unaffordability without procurement systems to ramp up demand, provide prompt delivery, and maintain quality where it matters at the point of use. In India, where the public sector is a major purchaser of health technologies, procurement is a powerful tool that can support or undermine regulatory intent. It is thus important to consider how India's disaggregated procurement system intersects with reform. In this sector, procurement is the bridge between market realities and regulatory policy. While stringent regulations are needed to keep devices safe and efficient, streamlined procurement can ensure that the devices reach health facilities on time and are available at reasonable prices.

Most countries now choose pooled or centralised procurement in health to realise economies of scale. A central buyer can negotiate volume discounts and reduce unit costs by pooling demand (e.g. all national public hospitals).^[95] India's lack of pooled purchasing has resulted in each state or hospital negotiating alone and thus paying higher prices for products of varying quality.^[96] Centralised bulk buying also enables stricter quality checks―an organisation can impose uniform standards and screen providers better than several uncoordinated buyers.^[97] The approach prevents stockout of necessary equipment through securing long-term, bulk-buying deals, which guarantee continuous availability. For example, if a single national agency purchases all insulin pumps or MRI machines, it can manage stockpiling and allocate the supplies where needed, instead of having individual states exhausting their stocks independently. Centralised tenders thus increase cost-effectiveness, consistency of device quality, and general supply reliability across the country.

While centralisation brings scale benefits, decentralised procurement can offer flexibility in addressing local health requirements. India's states are remarkably diverse with regard to disease patterns and requirements of the health system―a single national tender may not suit all. Decentralised systems would enable state governments to plan procurement lists and calendars tailored to their particular public health requirements. A state with a current caseload of, say, tuberculosis can allocate more to GeneXpert machines or X-ray units while another state can allocate a greater share to foetal monitors. Decentralisation also makes procurement faster and more responsive. State authorities are better attuned to ground realities and can make quicker decisions in an epidemic or crisis, without waiting for Central clearance. The problem now is how to achieve appropriate balance, or a hybrid model, that combines the strengths of these two alternatives to achieve scale efficiencies as well as local flexibilities.^[98]

Instead of calling for complete centralisation or a one-federal system of procurement, this paper advocates a hybrid model that combines economies of scale (by way of pooled or centralised procurement) with decentralised state-level autonomy. It can potentially benefit the indigenous industry and ensure value-for-money in the government sector, without compromising India's federal sovereignty.

Impact of India's Federal Model on Procurement

Given India's federal model, the responsibility for health care delivery―and, by logical extension, procurement of health commodities―rests firmly with state governments. The majority of states have established their own procurement agencies or medical services corporations to purchase medicines and equipment.^[99] State-level institutions actually procure 80‒100 percent of all routine medicines and diagnostics for public facilities, with minimal centralised purchasing at the national level.^[100] This gives the states a lot of power but results in extremely decentralised procurement processes. There is not one, monolithic system but a patchwork of state rules for tendering, vendor pools, and contracts for buying. General Financial Rules (GFR) 2017 and other rules are applicable to procurement by the Central government but the states have their own procedures or state law, leading to a "complex and fragmented procurement framework" with inefficiencies and lack of consistency.^[101],[102]

To harmonise the procurement procedures with a view to stimulating domestic industry and encouraging domestic procurement, the Central government has exercised its regulations on finance. GFR 2017 has included provisions to facilitate local sourcing, such as the Public Procurement (Preference to Make in India) Order and explicit bans on foreign tenders for lower-value procurement. In 2020, GFR 2017 was amended to disallow Global Tender Enquiry (GTE) for procurements up to INR 200 crore (approximately US$24 million). This means tenders below that threshold must be sourced from domestic firms except in special cases, a rule aimed at fortifying Indian manufacturers (especially micro, small, and medium enterprises) by shielding them from international competition in government orders.^[103]

Most state procurements may also exhibit this bias―for example, tenders may have a minimum local content percentage or offer preference in bidding for Make in India products. Although these conditions have enhanced the prospects of Indian device manufacturers, these may also complicate procurement for states with limited local players, especially in the case of high-end products. It is not feasible for states to invite an international tender for, say, a highly advanced cancer radiotherapy machine if the price is less than INR 200 crore, except under special circumstances. India’s federal setup and local preference policies thereby necessitate that states primarily procure from within India, which in turn influences their procurement planning.

Health technology assessment (HTA) can play a central role in improving the acquisition of medical devices. HTA's systematic reviews can guide national tenders for centralised procurement to ensure an efficient supply of cost-effective, quality equipment, such as MRI machines to institutions, thus facilitating economies of scale. For decentralised programmes, such appraisals may be modified by states or carried out separately to customise purchases according to local requirements, such as providing priority to certain equipment. Even though India has a federal structure in which state freedom of action results in diverse practices, HTA may provide a pathway towards a unifying solution. Its advisory nature and uptake by states may make quality and pricing more consistent.

Challenges to National Procurement Reforms

With constitutionally assured autonomy in health, a move towards a standard national system of procurement is politically challenging. States would naturally want to safeguard their health budget and control, since several of them have fashioned strong procurement institutions (e.g. Tamil Nadu Medical Services Corporation and Kerala Medical Services Corporation) in which they have confidence.^[104],[105] The state purchasing agencies have supplier relations and procedures responsive to their local conditions. They would need to overcome phobias about losing flexibility and control. Also, procurement is entangled in local politics and patronage; an interstate system would be seen as New Delhi (the Centre) encroaching on state business. Technical issues would also arise: states employ various e-procurement systems and tender forms, and attaining standardisation of these would need extensive coordination.

The availability of central buying programmes, such as the Central Medical Services Society (which was established to purchase on behalf of national programmes), has so far failed to displace state systems partly because its authority is limited and most orders continue to be under state control.^[106] The outcome is a phased approach―India has opted to enhance state procurement capacities (via guidelines, training, and incentivising good practices) instead of a single national agency.

Global Tender Enquiry (GTE)

GTE is an approach through which Indian government departments would remain receptive to inviting foreign vendors to tender for a contract without bureaucratic hurdles. Under the Make in India-driven procurement regime, GTE is to be an exception, to be used only when suitable domestic vendors or capacities are unavailable or impractical.^[107] In the medical devices segment, GTE has been a facilitator par excellence for the import of high-end, niche devices that Indian manufacturers are not yet producing at scale or with necessary technology.

For instance, in 2024, the government allowed global tenders for 354 advanced medical devices after the MoHFW discovered a domestic shortage.^[108] This action recognised that when it comes to advanced devices (like some implants, imaging equipment or precision radiotherapy machines), limiting procurement to local firms could leave hospitals without essential tools. Through the application of GTE in such situations, India can acquire advanced medical technology from the global market without second thoughts. GTE is thus a safety valve in the procurement process that ensures patient care is not adversely affected because of local industry's limitations. A department would otherwise have to obtain permission to release a GTE (especially if the order value is below INR 200 crore), explaining that there is no device manufactured locally, which meets the specifications needed. After clearance, tenders would be floated internationally and the best international manufacturers would be allowed to bid, introducing state-of-the-art products to replace gaps in care (like top-class diagnostic laboratories or surgical robots).

On the other hand, opening up imports via GTE can disrupt the demand for domestically manufactured products, thereby reducing incentives for manufacturers to invest in such product lines. If government hospitals continue importing a specific line of high-technology equipment either for quality or availability, Indian companies may not have much market incentive to make a substitute product. This is the essence of the INR 200-crore tender cap―to compel purchasers to think nationally first. Undue GTE, exemptions can help create a reliance on imports for cutting-edge technology, which is contrary to the final objective of being self-dependent (Atmanirbhar Bharat). Conversely, demanding solely local sourcing may compromise patient care and clinical results in the short run, if none of them is able to bring in the innovation needed.

Lessons from International Models

Ireland, for example, has been moving towards a more centralised procurement system within its national health service. As a relatively small country with a unitary health system, Ireland found that fragmented purchasing was inefficient. It has aimed to create a single purchasing authority or at least coordinated ‘category management’ of medical device buying. The Irish experience shows that centralisation can maximise bargaining power and reduce duplication, but it also cautions that overly rigid central control may stifle innovation or ignore local clinical preferences.^[109]

Across the broader European region, many EU nations use pooled purchasing either at the national or multi-hospital level. Pooled procurement has become prevalent across EU member states, taking forms like group purchasing organisations, national tenders, and even multi-country joint procurements. This trend is driven by the clear gains in cost-efficiency; collective buying exerts strong downward pressure on prices, which in turn benefits public health budgets. For example, countries like Italy and Spain have used centralised tenders for expensive devices (like stents or scanners) to save costs while Nordic countries sometimes form purchasing alliances for specialised equipment.^[110]

The European Union as a whole introduced a joint procurement agreement in 2014 to enable voluntary pooled procurement for its member countries in crises. Under this mechanism, EU countries jointly negotiated purchases of medical countermeasures during the COVID-19 pandemic, which helped secure equitable access and better pricing for vaccines and critical supplies.^[111] Such models show that federated/collaborative procurement structures can work, using centralised negotiation to achieve efficiency while still allowing local decision-making.

China provides a contrasting model of a highly centralised state using every policy lever to boost domestic medical device manufacturing. Over the past decade, China has aggressively encouraged local MedTech production through a mix of regulatory fast-tracking, financial incentives, and procurement preferences. The Chinese regulator, NMPA, introduced a fast-track approval pathway for “innovative medical devices,” granting priority review and support to novel domestic products.^[112] This has significantly shortened the approval timelines for Chinese manufacturers who develop cutting-edge devices, enabling them to reach the market faster. Additionally, special zones like the Hainan Boao Lecheng Medical Tourism Pilot Zone allow expedited use of new devices (including some not yet fully approved nationally), which not only benefits patients but also provides local firms with a place to trial innovations quickly.^[113]

On the fiscal side, China has offered generous tax breaks and R&D incentives to medical device companies. High-tech MedTech firms in China can qualify for a preferential corporate tax rate (often 15 percent, lower than the standard rate) and super-deductions on R&D expenses.^[114] These tax concessions reduce the cost of innovation and manufacturing, making domestic companies more competitive against imports. In fact, Chinese domestic firms have captured a growing share of the market―as per an analysis, they hold over 75 percent of China’s medical device market by value today, a stark change from a decade ago when foreign multinationals led in high-end equipment.^[115] China achieved this by pairing industrial policy with procurement policy, introducing volume-based procurement (VBP) in which bulk orders (especially for consumables and implants) are awarded at very low prices, a practice that favoured cost-competitive local producers.^[116] Beyond price-driven models like China's, India needs a value-driven approach to procurement, one that health technology assessment (HTA) is uniquely positioned to support.

Health Technology Assessment

Health technology assessment (HTA) plays an important role in informing wise medical device purchases through a systematic assessment of the benefits and risks of each technology. It is a multi-disciplinary activity that reviews a device's clinical effectiveness, effect on patient outcomes, cost-effectiveness, and system implications.^[117] By evaluating both the health benefits and costs of medical devices, HTA helps determine which technology delivers the greatest health value for the resources invested. For instance, an HTA can incorporate comparative effectiveness studies, cost‒benefit analyses, and even patient satisfaction scores to estimate the real value of a device or intervention.^[118] India realised that HTA was essential in rationalising procurement into needs-based and effective buying.

In 2017, the government initiated the Health Technology Assessment in India (HTAIn) programme as an expert institutional instrument for producing evidence to support health-care decision-making. HTAIn was created under the Department of Health Research to perform appraisals of new and emerging health technologies for their suitability and affordability in the Indian setting.^[119] By harmonising HTA practices among states and hospitals, India can promote value-for-money procurement driven by clinical needs instead of market availability. Some of the critical assessments that HTAIn has conducted involve studying the cost-effectiveness of safety-engineered syringes, screening policies for cervical cancer, and rolling out the Truenat diagnostic platform for TB.^[120],[121] These assessments show that HTAIn can be a valuable tool in rationalising the utilisation of health-care resources. India has also participated in global partnerships to enhance HTA capacity. One of the important partnerships is with Thailand's Health Intervention and Technology Assessment Program (HITAP) that allows for capacity development and experiential learning.^[122] This collaboration enabled Indian researchers to conduct local economic evaluations and enhance the integration of HTA into national health policies. With all these initiatives, HTAIn continues to grow, fostering a culture of evidence-based decision-making.

In real terms, HTAIn scale-up implies procurement authorities have evidence-based data on what works and what does not in Indian conditions to prioritise high-impact, cost-saving devices for public spending. In the long term, an embedded HTA process can make budgeting more rational, directing funds to medical devices with the most pressing needs (e.g. critical diagnostics or life-saving devices), with established effectiveness.^[123] While HTA is the evidence base for assessing the clinical and economic value of medical technologies, VBP is the administrative mechanism for translating that evidence into action. VBP enables procurement officials to transcend cost minimisation and procure devices according to their ability to provide health outcomes per rupee of expenditure. HTA and VBP are, therefore, complementary: one creates insight while the other translates that insight into procurement action.

Value-Based Procurement

Value-based procurement (VBP) is a new system that focuses less on the procurement cost of a health device and more on the total value over its lifetime. The traditional way of procuring in India's health sector has historically inclined towards the lowest bidder (the L1 bidder), which suits short-term cost minimisation. This approach under which contracts are awarded to the technically qualified lowest bidder guarantees that while cost savings are assured, all bidders must first qualify with specified technical and quality parameters before their financial bids are looked into.^[124] VBP, on the other hand, measures products relative to one another, based on how they support long-term outcomes and overall cost of care. This implies that when hospitals or governments evaluate a device, they consider not only its acquisition cost but also its reliability and durability, maintenance and consumables cost, training costs, patient safety and outcomes benefits, and even end-of-life disposal.^[125],[126] By taking these factors into account, procurement officials try to decide which device will provide the greatest health outcomes per unit of cost in the long run. In reality, a costlier machine with a longer lifespan or a greater patient recovery rate may be selected over a less costly, lower-duration machine. In other words, VBP entails purchasing products based on the best way in which these are able to provide predetermined health outcomes and minimise overall care costs, instead of seeking the lowest price. This forces producers to compete based on value and innovation, and not on discounts; it aligns procurement with value-for-patient and value-for-system principles, reflecting the broader objectives of value-based health care delivery.

European and Swedish experiences illustrate the change-making potential of VBP. Sweden has been at the forefront of implementing integrated, outcome-based tendering instead of just lowest-price bidding. For instance, the Health Care Services Stockholm County (SLSO) organised a groundbreaking procurement for wound-care products, wherein the bidders were required to estimate the overall cost of treating hypothetical patient cases, including healing results, instead of quoting a unit price.^[127] Such value-based procurement paid off in the form of improved patient outcomes (more rapid healing of the wound with fewer complications) and overall treatment cost, demonstrating how attention to value in the long run can override short-term attention to cost.^[128] Beyond that, nations such as the United Kingdom (UK) and Sweden now incorporate measures of outcome and long-term factors of value into medical tenders, tying payment for part of it to the outcome achieved.

This is paralleled by the European Union's procurement policy (i.e. the Most Economically Advantageous Tender or MEAT philosophy) in the sense that it promotes thinking beyond price, and adopting quality and cost over lifetime.^[129] If India adopted the same VBP practices, then it would be a paradigm shift in the procurement culture―from considering medical devices as commodities to acknowledging them as partners in the delivery of care.

Indian health authorities and hospitals can, for example, design contracts in such a way that device manufacturers are partially paid (or even rated), depending on the quality of their product performance, to better enhance patient outcomes. However, for VBP to succeed, it needs a value-true pricing mechanism that will allow for open, fact-based negotiations. That is where global pricing mechanisms, especially those supported by the World Health Organization (WHO), come into play. They provide procurement agencies with comparative standards and pricing tools that can be utilised to bring in affordability without compromising on supplier viability.

WHO Guidelines for Pricing

To fund innovations such as HTA and VBP, India can also use various international pricing mechanisms recommended through WHO to pay reasonable prices for medical devices.^[130] Reference pricing is one such tool whereby procurement agencies cross-shop the price of a medical product across countries or regions in a bid to secure a better price.^[131] By taking international price benchmarks as their reference, the buyer can determine whether a quoted price is appropriate or whether a device is being offered at a premium in India. This has worked for pharmaceuticals and is working for devices as well. If, say, hospitals in Southeast Asia or Europe receive a 30-percent discount on some implant or MRI machine, Indian consumers can leverage this fact to then gain the same type of price with differential adjustment for their local factors.

WHO equitable pricing advice also boils down to encouraging transparency and value pricing―price determined by what health output a technology provides.^[132] For India, it would be a balancing act between sustainability and affordability: the aim would be to drive prices low enough to be equitable for a lower-middle-income health system, yet high enough to incentivise suppliers to keep offering quality devices. Even the most logical pricing strategies are, however, vulnerable to being undercut by local tax structures. By taxing crucial medical devices at multiple slab rates, India's Goods and Services Tax (GST) regime tends to elevate cost and complexity for otherwise low-cost technology.

India's GST Regime

India's domestic tax system―the Goods and Services Tax (GST) in particular―plays a significant role in determining the affordability and purchasing of medical devices. Under the current GST system, medical devices are taxed under different slab rates, which directly influence the cost of procuring such items. Essential drugs and some chosen essential equipment benefit from a low GST rate (typically 5 percent), but most of the medical devices incur 12 percent GST.^[133] Other than that, quite a few hi-tech or high-end medical equipment (‘non-essential’, from the taxman's point of view) are also eligible for 18 percent GST, the top slab. For example, things like diagnostic equipment, surgical robots or foreign sophisticated implants would attract this 18 percent duty. The rationale is to tax these devices at higher rates as a source of revenue from non-essential medical products; however, in practice, this raises the cost of acquiring precisely those technologies that are needed to modernise hospitals.

Regardless of whether a private hospital or a public hospital purchases a machine, the GST is factored into the price―either the government health budget must go further or the private hospital passes on the cost to the patient. Either way, a greater initial cost can deter the purchase of sophisticated machinery. Take, for example, an imaging machine that costs INR 1 crore (~US$125,000). With GST at 18 percent, it will effectively cost INR 1.18 crore―that price could possibly exclude some district-level hospitals. Thus, the existing GST system with its slabs may at times produce misaligned incentives― hospitals may be unwilling to buy an expensive piece of machinery not only for the base cost, but also for the steep add-on tax.

There has been some controversy regarding whether a change in GST policy would be able to benefit procurement results for medical devices. Some industry professionals and other stakeholders have suggested that rationalising GST rates or offering tax concessions for essential medical devices would make cutting-edge health care more accessible. Reducing the GST on all medical devices to a single reduced rate has been one of the proposals―i.e. 5 percent or 12 percent, compared with the existing range of 5‒18 percent.^[134] Supporters of the proposal point out that a single low GST would simplify the tax system and eliminate the tax on advanced equipment, thereby encouraging hospitals to buy newer devices without tax-related cost anxieties.

Equally, tax benefits can be harmonised with the Make in India dream: for example, low GST (or extra GST credits) on locally produced devices can not only reduce their price for consumers, but also augment local production. The effect of such a shift could be significant. Reducing the rate of effective tax on medical devices would lower provider costs, facilitating reinvestment in additional equipment or ancillary services (technician training or device maintenance).

These reforms―rationalising GST, embracing VBP, WHO-supported price models, and incorporating HTA―are not piecemeal fixes. Combined, they form a logical set of levers that can assist India in rebalancing its medical devices ecosystem in the direction of long-term value. But these tools need to function within a larger institutional ecosystem of stable regulation, robust post-market surveillance, and a contemporary, industry-savvy governance model.

Conclusion

Even as the Indian market for medical devices is poised to grow exponentially, the question is whether the country can usher in a regulatory climate that is aligned with the imperatives of innovation, investment, and patient protection. The shift from the antiquated drug-based regulation to a professional regulation for medical devices has materialised after sweeping reforms but loopholes remain. The industry cannot sustain itself on policy passion alone; India must assure predictability, efficiency, and accountability in regulatory and procurement frameworks to allow long-term expansion.

Modernisation of the regulatory process is inevitable. Adopting best practices elsewhere in the world, India requires a specialist, independent regulator such as the US FDA's CDRH or Japan's PMDA. The National Medical Devices Policy 2023 and the Draft New Drugs, Medical Devices, and Cosmetics Bill 2022 are steps in the right direction, although these are more interested in industrial growth than in regulatory transformation. Closing these loopholes is essential for making regulation as well as procurement predictable, efficient, and accountable.

Procurement must escape the current cost reduction mentality. The current setup in India is marked by decentralisation, price-based tendering, and multilateral state-level procurement. This often tends to favour the lowest bidder at the expense of long-term value. A strategically aligned procurement plan that integrates HTA and VBP can potentially guide more evidence-based, outcome-oriented purchasing decisions. Price strategies have to balance affordability and sustainability as well. Although price control measures like the initiatives of the National Pharmaceutical Pricing Authority (NPPA) on coronary stents have enhanced availability, abrupt policy change deters investments.^[135] Price ceilings have to go hand-in-hand with research incentives, manufacturing incentives, and quality indigenous production incentives.

To build a strong ecosystem, India will have to create a specialist medical device regulator, independent of pharma regulation and imbued with industry-focused expertise. At the same time, post-market surveillance functions, such as the Materiovigilance Programme of India (MvPI), need to be supplemented by obligatory reporting of adverse events and a safety database openly accessible to the public for the sake of regulatory transparency. Procurement procedures need to incorporate HTA and VBP principles, moving beyond price-oriented tendering, to focus on long-term value and patient benefits. Price control needs to be redesigned to balance costs with incentives for investment using WHO reference models for pricing to ensure that costs remain transparent while maintaining the sustainability of the MedTech industry.

Finally, rationalisation of GST on medical devices, i.e. the lowering of rates for critical and high-technology equipment, would make such devices more accessible and encourage health-care providers to invest in advanced medical technologies. By including these structural reforms in policy, India will be able to create a regulatory and industrial climate that will be attractive to both domestic innovators and global competitors.

Overall, five priorities for India's near-term follow-up steps to regulatory reform are:

(1) Expediting the passage of the draft Bill 2022 with the establishment of an independent medical device regulator.

(2) Harmonising the MvPI with the required reporting of adverse events and public access to data.

(3) Implementing a tiered price mechanism that maintains innovation protection vis-à-vis affordability.

(4) Fundamentally transforming procurement policy to encourage quality domestic manufacturing with linked incentives and global prequalification.

(5) Pushing forward harmonisation with global platforms, including implementation of Unique Device Identification (UDI) and codified guidelines for SaMD.

India's ambitions of becoming a global MedTech hub rests upon an integrated regulation and procurement strategy. A stable, innovation-friendly regulatory framework, coupled with effective procurement and sustainable pricing, will increase investment, enhance patient safety, and build a strong medical device sector. The window of opportunity is present now. If India succeeds in making these structural shifts, it can not only minimise its dependence on imports, but can also become the world leader in high-quality, affordable medical technology.

Endnotes

• Healthcare
• European Union
• India
• USA and Canada
• The Pacific, East and Southeast Asia
• cdsco
• india's medtech transformation
• materiovigilance programme of india
• mdr 2017
• medical devices ecosystem in india
• medical devices industry in india
• medical devices regulatory framework
• medical devices rules
• medical devices sector in india
• medical technology
• MedTech
• national medical devices policy 2023

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