One world, one forum: Harmonizing the medical device regulatory framework

1. Challenges of the Current System

• Variability among international regulatory bodies poses challenges for innovation, public safety, market entry, and regulatory approvals.

• Global disparities in classification, lack of harmonization, and divergent regulatory frameworks contribute to trade deficits, economic strain, and profit erosion.

2. “One World, One Forum” Concept

• Proposes a globally unified regulatory framework for medical devices to ensure consistency in safety, accessibility, and compliance.

• Potential benefits include:

  • Faster market approvals

  • Reduced compliance costs

  • Increased global trade

  • Promote safety and quality

  • Improve accessibility and traceability

  • Secure vulnerability.

3. Recommendations

• Adoption of the “One World, One Forum” approach to standardize MedTech services, practices, and quality benchmarks.

• Expansion of the International Medical Device Regulators Forum (IMDRF) to include a broader range of countries.

• Develop and implement globally accepted standards and materiovigilance network for medical devices. Establishment of globally accepted standards and a strong materiovigilance network for medical devices.

• Alignment of national regulatory frameworks with international standards to streamline approval processes and enhance global trade.

4. Conclusion

• Harmonization of medical device regulations benefits both patients and the MedTech industry by ensuring safety, efficiency, and innovation.

• Strengthening international collaboration and harmonization efforts will create a unified regulatory ecosystem, placing all medical devices under a common regulatory framework.

Comprehensive gap analysis of the IMDR

The Indian Medical Device Regulatory Framework, despite its evolution, faces significant challenges and gaps that hinder its efficiency. The COVID-19 pandemic exposed the dire shortage of medical equipment, emphasizing the need for robust domestic manufacturing capabilities to reduce reliance on imports, which currently account for 70-75% of medical devices.^5,9-12 Studies emphasize that Public-Private Partnerships (PPP) are suggested as a solution to drive innovation and economic growth.⁵ However, complex legal terminologies in the IMDR create barriers for stakeholders, necessitating user-friendly regulatory statutes.^5,9,10,13,14 The Materiovigilance Programme of India (MvPI) was established to promote the safety of medical devices through post-market surveillance. The IPC serves as the National Coordination Centre for MvPI. Adverse event reporting form (MDAE Reporting Form) is available both in English and Hindi, for use by manufacturers/importers/distributors, healthcare professionals, and others. A major issue is the lack of awareness regarding adverse event reporting, leading to unreported adverse events and potential patient safety risks, which can be improved by regular training programs and workshops to strengthen materiovigilance efforts.^7,9,10,15-20 The IMDR also lacks well-defined standards and guidelines for quality benchmarks,^21,22 particularly for high-risk devices, unlike global counterparts such as the EU MDR and IVDR, which provide a broader range of tools and methodologies for PMS. Additionally, India lacks a national registry or comprehensive healthcare database that systematically maintains the details of the patients’ central safety database system, which should be accessible to the stakeholders for reporting and tracking adverse events.^7,13,22 India did not have an adequate mechanism for real-time data collection to monitor device performance. Regulatory transparency by systematic disclosure of information regarding device approvals, adverse event reports, and post-market studies is yet to be captured in a unified reporting portal and made available for public view. These are essential to foster public trust and accountability.

India’s regulatory framework is further strained by the absence of unified legislation for software as a medical device (SaMD) and AI-driven technologies, despite projections indicating their widespread adoption.^13,14 There is a web of laws involving different regulatory bodies, with each having an independent aspect to consider. Current regulations do not address critical concerns such as software updates, patient data security, and informed consent, putting India behind international regulatory advancements. In a true sense, the current Indian regulations on the use of software as a medical device (SaMD) are still emerging with an increase in the use of AI technologies. Additionally, classification challenges persist, particularly for AI-driven and software-based medical devices, leading to inconsistencies in regulatory oversight.^5,13,23-28 The misalignment of IMDR with global standards further restricts international trade and market competitiveness, particularly in the case of IVDs, where experts recommend a separate regulatory framework similar to the EU IVDR.^7,29-35 The industry also suffers from a shortage of qualified regulatory professionals, which delays approvals and impairs compliance.^{5,9,10,12,22,32,33,36,37} The cost burden of compliance remains another major hurdle, especially for startups and small manufacturers, as high licensing fees and clinical investigation costs discourage innovation.^{5,10,13,18,33} Furthermore, India faces significant regulatory approval delays, often taking three to four years, a phenomenon referred to as “medical device lag,” which deters foreign investment and weakens domestic industry growth.^{5,7,9,13,14,33,36,38-40} Addressing these issues requires harmonization with global standards, streamlining approval processes, and fostering a regulatory ecosystem that promotes innovation while ensuring patient safety. Experts suggest forming a dedicated regulatory division within the CDSCO to oversee SaMD, developing structured regulatory education programs to bridge the talent gap, and reducing administrative inefficiencies to accelerate market access. Strengthening PMS mechanisms, institutionalizing clearer quality benchmarks, and aligning regulatory frameworks with international best practices will be essential for the Indian MedTech industry to thrive. A shorter regulatory approval timeline can attract foreign investors, increase exports, reduce imports, and strengthen the indigenous supply chain. Additionally, introducing academic curriculums for postgraduate specializations or diploma programs focusing on regulatory affairs in Indian universities could help bridge this gap, producing a larger pool of skilled professionals to meet industry demands. Implementing these reforms will not only enhance compliance and patient safety but also position India as a competitive global hub for medical device manufacturing and innovation. A retrospective review of 46 publications from 2018 to 2024 revealed 14 major challenges confronting the Indian MedTech sector, as detailed in Table 1(a,b), and Figure 2.

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Figure 2:

Analysis of key challenges in the Indian medical devices regulatory framework based on the literature review. PPPs: Public-private partnerships; IVD: In-vitro diagnostics; PMS: Post-market surveillance; SaMD: Software as medical device.

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Comparative analysis with the international regulatory framework

Currently, the Indian medical devices market is valued at around $11 billion, placing India at 16th position in the global ranking.¹¹ The Indian medical device sector is in transition from reliance on imports to a possible worldwide manufacturing center for MedTech by 2030. The Indian MedTech market is expected to grow from its present 2023–2024 valuation of US$12 billion to US$50 billion. Within 25 years, the Indian medical device industry’s present 1.65% worldwide market share is anticipated to increase to 10%–12%.

The US is the main market for India’s MedTech exports, which totaled US$3.8 billion in 2023–2024. However, the recent decisions to increase tariffs by President Donald Trump’s administration could make Indian drug & medical devices more expensive in the US market, potentially shrinking exports and forcing the Indian MD & pharma sector to look beyond the US.

An alternative is the free trade agreement (FTA) with the UK & EU, which is being discussed. This might result in zero tariffs on medical devices imported into the EU from India, potentially increasing the competitiveness of Indian products. However, the EU’s demand for zero tariffs on medical products continues to impose stringent regulations that make it challenging for Indian exports to reach EU markets. Under these circumstances, it is obvious that India would negotiate for reciprocity to reach a fair-trade agreement. The EU is still a significant market in 2024, with USD 1.15 billion in imports and USD 580 million in exports.

Indian gadgets’ adoption in important regulated markets is restricted by their non-participation in the Medical Device Single Audit Program (MDSAP). The MDSAP was developed by the IMDRF to streamline the regulatory process for medical device manufacturers and promote consistency among participating regulatory authorities. Through MDSAP, medical device makers can undergo a single audit to ensure compliance with regulatory standards across many markets, including the US, Australia, Brazil, Canada, and Japan. India must review its participation in these global harmonization programs and implement changes, such as pursuing mutual recognition agreements (MRAs) with the regulated markets in line with the ISO (International Organization for Standardization) harmonized norms, to facilitate exports in the EU and other emerging regulated markets.

To improve India’s standing among the elite groups, various research studies and comparative analyses have been conducted to bridge the gaps between developing and developed countries. Accordingly, this section aims to perform a literature review-based comparative analysis of India in relation to the global medical device market leaders, including the USA, the EU, and Japan. A comparative analysis of these four major regulatory jurisdictions has been shown in Figure 3.

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Figure 3:

Comparative analysis of regulatory jurisdictions between US, EU, India, and Japan. CDSCO: Central drugs standard control organization; EC: European commission; FDA: Food and drug administration; PMDA: Pharmaceuticals and medical devices agency; SME: Small and medium enterprise.

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Regulatory structure

Another disparity lies in the regulatory structure. The USFDA is a single agency overseeing the regulation of food, drugs, medical devices, biologics, cosmetics, etc. This centralized system imposes a complex regulatory ecosystem, potentially impacting efficiency. In contrast, India benefits from a more segregated system with dedicated ministries, departments, and authorities to handle various essential products, allowing for better specialization and focus. To further enhance this advantage, India could explore strategies to optimize coordination and communication between these dedicated entities

Divergence in risk classification

Divergence in risk classification systems highlights variations in regulatory stringency, risk perception, and market access requirements across different jurisdictions. The US has the highest import shares in the Indian MedTech market. According to a report by the United States International Trade Commission (USITC), the US exports 70% of medical goods to India, and has 22% of import shares in its medical device market.⁴² Shristi 2024,²¹ Chatterjee and Dohan 2021,²³ Ganapathy K. 2021,²⁶ Dipika Jain 2022,²⁴ Ramachandran et al. 2023,¹³ and Suravarapu and Yetukuri 2023,²⁸ underscore that the IMDR does not provide a comprehensive definition for all categories of medical devices. For instance, emerging technologies like software-driven or AI-based devices often lack clear classifications or definitions within the framework. This ambiguity can lead to inconsistent regulatory oversight, potentially resulting in some devices being excessively regulated while others remain under-regulated. Additionally, India adopts a harmonized four-tier risk-based classification system, while the USA employs a three-level risk-based classification system for medical devices, which can pose limitations when it comes to effectively regulating a wide range of medical devices. For example, a non-invasive glucose monitoring device might be Class I in the US, but its classification in India could vary in both Class A and Class B category depending upon the device’s exact features, specifications, safety, and purpose of intended use.

Lessons from medical device case studies

A unique feature of medical devices is their classification based on risk levels. Regulatory frameworks across all jurisdictions categorize medical devices into a minimum of three and a maximum of four tiers of classification. A comprehensive risk-based classification of medical devices, IVD, and SaMD within the regulatory frameworks of the IMDRF, India, EU, Japan, and the US have been presented in Table 2. However, the fundamental principle for classification remains the same. The classification starts with low-risk medical devices, for which regulatory approvals are relatively easy, as these devices pose minimal risk to the end user’s health. Examples include bandages, cotton wool, and stethoscopes. But, as the level of risk increases, the probability of harm to life rises. Consequently, risk assessment, quality management, and testing protocols become more stringent, clinical or performance evaluation is a mandatory requirement, inspections and post-market surveillance are intensified, and safety measures are reinforced, leading to heightened regulatory oversight.

However, despite stringent regulatory checklists, the following case studies reported by several studies have highlighted the disparities, lapses, inconsistencies, and negligence, which have resulted in serious adverse events (SAEs). According to Rule 3(zq), Chapter I of the IMDR,⁵³ an SAE is defined as an untoward medical occurrence that leads to death or a serious deterioration in the subject’s health, which can result in:

• i.

  Life-threatening illness or injury;

• ii.

  Permanent impairment of a body structure or a body function;

• iii.

  In-patient hospitalization or prolongation of existing hospitalization;

• iv.

  Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function; or

• v.

  Fetal distress, fetal death, or a congenital abnormality, or birth defect.

Medical device callouts, while crucial for patient safety, could have immediate setbacks, including delays in treatment, financial burden to patients, and increased scrutiny from regulatory agencies, but enable preventative actions to keep patients safe. By identifying design, manufacturing, or usage flaws, data analysis aids in better product development and testing procedures. To make sure that the rules are adjusted and that the devices are continuously enhanced for safety and efficacy, the medical device industry and regulatory bodies can learn a lot from these investigations and evaluate and update procedures.

One world, one forum

India has given the motto of “One Earth, One Family, One Future” at its G20 summit of 2023. The MedTech sector also needs this global collaborative approach to ensure its performance, safety, and quality. The concept of “One World, One Forum” provides a globally unified platform to promote safety, ensure accessibility, improve traceability, and secure vulnerability. Here are some strategic eight suggestions for enhancing the international medical device regulatory framework.