THEMATIC SESSION ON Regulatory Cooperation between Members on
Medical Device Regulation

25 march 2025, 16:30-18:00

Moderator's Report[1]

At the Tenth Triennial Review, Members agreed to continue to hold thematic sessions in conjunction with the TBT Committee's regular meetings from 2025 to 2027 to further deepen the exchange of experiences on specific topics. On this basis, the Committee agreed to hold a thematic session on Regulatory Cooperation between Members on Medical Device Regulation.^[2] Information about the speakers, presentations, and related materials is available on the WTO website.^[3]

1  introductory remarks by the moderator

1.1.  Regulatory cooperation and convergence play an important role in reducing trade barriers and ensuring timely access to essential medical goods, such as medical devices. The 27^th session of the International Medical Devices Regulators Forum (IMDRF), held in March 2025, was mentioned, including the approval of a new industry group, with the first official bilateral meeting with the Management Committee and the new industry group dubbed a "milestone" by global regulators.

2  Guiding questions

·_              What are the main regulatory challenges in the area of medical devices, including in the context of new emerging technologies (such as AI) and new products (such as "personalized medical devices" (PMD) or "software-as-a-medical-device" (SaMD))?  

·_              What are the key regulatory approaches that can help enable flexibility, harmonization, and mutual recognition of medical device regulations? Why and how can these approaches be both beneficial for trade and better for health outcomes?

·_              What are the benefits and key challenges related to the uptake of international standards for medical devices?

·_              How are these approaches and challenges connected to the TBT Agreement disciplines as well as TBT Committee discussions and guidance?

·_              Post-market surveillance (PMS) is critical to ensuring the continued safety and effectiveness of medical devices once they are in use. What are the key challenges in implementing robust post-market surveillance systems, and how can regulatory bodies, manufacturers, and healthcare providers collaborate to improve the collection and analysis of real-world data to better monitor device performance and address emerging safety concerns?

3  Interventions

3.1  Round one

3.1.  Dr Ranga Chandrashekhar (India)[4] emphasized regulators' fundamental responsibility in ensuring the access of patients to safe and high-quality medical devices. He highlighted three strategic regulatory approaches to facilitate trade and health outcomes effectively. First, he underscored the importance of adopting international standards, particularly ISO standards, as a critical first step towards regulatory harmonization and convergence. Second, he underscored the importance of implementing regulatory reliance mechanisms, recommending that regulators recognize authorizations granted by established regulatory authorities internationally, thus avoiding the duplication of work. Third, he proposed conducting joint regulatory reviews and encouraged pursuing both bilateral and multilateral mutual recognition frameworks. Reflecting on India's experiences in granting expedited emergency approvals, he also suggested that the WTO could provide essential support in this area, including by establishing guiding frameworks for mutual recognition, particularly during public health emergencies.

3.2.  Mr Naoki Morooka (Japan)[5] noted that Japan's medical device industry has opted for a proactive approach toward international regulatory convergence, emphasizing Japan's sustained engagement through the IMDRF. Mr Morooka described Japan's support for a stepwise convergence approach, prioritizing compliance with essential principles and international standards during the pre-market conformity assessment phase. He also referred to the newly established IMDRF industry group, which aims to facilitate clearer communication between industry and regulators.

3.3.  Mr Morooka introduced practical mechanisms for harmonizing regulatory approaches and facilitating mutual and multilateral recognition, such as the "Reliance Guidance by WHO or Reliance Playbook by IMDRF". He stressed the crucial role of regional cooperation in effectively addressing regulatory gaps and overcoming existing barriers, highlighting the role of forums such as APEC and IMDRF. Mr Morooka also noted the existence of significant challenges arising from divergent timelines and inconsistent adoption of updated editions of international standards, most notably the IEC 60601-1 standard for medical electrical equipment, where multiple and simultaneous editions created significant uncertainty for manufacturers. To mitigate these difficulties, he recommended strengthening coordination, clearer planning, and synchronized implementation efforts between regulatory authorities and international standardizing bodies such as the ISO and IEC. This approach, he argued, would greatly enhance predictability and reduce regulatory uncertainty for the global medical device industry.

3.4.  Dr Gideon Too (Kenya)[6] presented Kenya's recent experiences in leveraging regulatory reliance mechanisms, notably during urgent situations such as the COVID-19 pandemic and the HIV/AIDS crisis. Dr Too underlined Kenya's strategic shift toward reliance-based regulatory practices, which includes the practices of recognizing approvals from international regulatory authorities, as well as leveraging existing international standards (such as those from the ISO and IEC) and IMDRF guidelines. He stressed the effectiveness of reliance mechanisms in facilitating the authorization and importation of critical medical devices, significantly improving the response efficiency during health emergencies. Dr Too highlighted that regulatory reliance is particularly beneficial for resource-constrained regulatory systems, stressing the importance of continued engagement and capacity-building support for developing Members in adopting these international frameworks to ensure timely patient access to essential medical technologies.

3.5.  Ms Nada Alkhayat (European Union)[7] addressed regulatory complexities arising from the integration of emerging digital technologies, such as AI, into medical devices. She noted that one in four medical devices are either themselves software-based or are software-enabled medical devices, which creates distinct regulatory classification challenges.

3.6.  Ms Alkhayat elaborated on the EU comprehensive regulatory approach, specifically integrating a horizontal AI regulatory framework—through the Artificial Intelligence Act—with existing sector‑specific medical device regulations. She stressed the necessity for agility and science-based decision-making in regulatory processes, acknowledging additional cross-sectoral issues, like cybersecurity and data protection, as significant regulatory concerns. Emphasizing collaboration, Ms Alkhayat underscored the need to harmonize horizontal and sector-specific regulations, recommending sustained international dialogue through platforms like IMDRF to ensure consistent regulatory approaches globally.

3.7.  Ms Elaine Grimes (United Kingdom)[8] highlighted the critical role of effective PMS systems to ensure the safety and effectiveness of medical devices that have been placed on the market. She identified three primary challenges for effective functioning of PMS systems: (i) data collection issues, including significant under-reporting and inconsistent data submissions, illustrated by the fact that approximately 95% of hip and knee replacements in the United Kingdom are discarded after revision surgeries instead of being returned for analysis; (ii) resource constraints, with new regulatory requirements demanding manufacturers to proactively collect user experience data, conduct detailed statistical trend analyses, and engage more extensively with patients and the public; and (iii) complexities arising from varying international reporting obligations, with manufacturers facing differing timelines and scopes for reporting serious incidents, corrective actions, and adverse trends across multiple jurisdictions.

3.8.  To address these challenges, Ms Grimes emphasized the need for enhanced collaboration between regulators, manufacturers, and healthcare providers. She suggested that regulators utilize international platforms, particularly the IMDRF, to harmonize reporting processes and advocate for the widespread adoption of the IMDRF Adverse Event Terminology for consistency. She presented recent UK initiatives in this area, including the comprehensive guidance documentation released by the Medicines and Healthcare products Regulatory Agency, which aims to outline reporting responsibilities, enhance data quality, and facilitate industry compliance.

3.9.  Ms Grimes further underscored the vital role of healthcare professionals in supporting robust PMS systems. She suggested that awareness among healthcare providers regarding their PMS responsibilities should be increased through targeted educational programs, stakeholder engagement events, and practical initiatives. She highlighted the innovative example of the Implant Analysis Service of the UK's National Health Service, which independently assesses explanted medical devices, significantly improving real-world data collection and analysis. Ms Grimes concluded that strengthening PMS practices will substantially enhance regulatory oversight and patient safety, providing a solid basis for implementing regulatory reliance pathways.

3.10.  Mr John Jamieson (Australia)[9] emphasized the importance of having robust regulatory convergence and reliance frameworks to mitigate disruptions caused by seemingly minor divergences in regulatory practices. He noted that, even slight discrepancies in definitions, risk classifications, and device nomenclature standards, could significantly delay market entry, increase compliance costs, and hinder regulatory interoperability across jurisdictions.

3.11.  To strengthen regulatory coherence, Mr Jamieson called for expanded reliance frameworks, recommending greater alignment of domestic regulations with international standards, especially in the area of cybersecurity and data governance. He also noted the importance of intensified international collaboration via IMDRF and similar regulatory fora to streamline regulatory reliance practices and maintain coherent regulatory frameworks, ultimately ensuring faster patient access to advanced and critical medical technologies globally.

3.12.  Ms Sandra Ligia González (Inter-American Coalition)[10] highlighted initiatives aimed at enhancing closer cooperation between trade and healthcare regulatory authorities to support the effective implementation of the TBT Agreement. She noted that trade barriers can be effectively addressed through more active engagement of health authorities, recalling recent discussions between Kenya's Pharmacy, Poisons Board and the Inter-American Coalition. In this context, Ms González stressed that trade authorities should actively assist health authorities in developing and implementing Standard Operating Procedures to ensure compliance with the TBT Agreement's principles as well as Good Regulatory Practices. This institutionalized approach would significantly reduce regulatory divergence and avoid unnecessary technical barriers to trade.

3.13.  Ms González further emphasized the importance of proper implementation frameworks that promote regulatory reliance and convergence. She cited successful examples of international convergence in the medical devices sector, such as the Medical Device Single Audit Program. She suggested that Members actively document and track their compliance with the TBT Agreement's disciplines and share best practices and guidance, as the IMDRF does regarding the implementation of their Guidance Documents by their members.

3.2  Round two

3.14.  Recently, at the 13^th Ministerial Conference, WTO Members reaffirmed the TBT Agreement's relevance to modern global trade challenges and emerging policy concerns, including measures taken to address human health in general and global health pandemics in particular. They noted that close regulatory cooperation among Members was fundamental in addressing the COVID-19 pandemic by facilitating trade through the reduction or suspension of unnecessary regulatory barriers, use of international standards or temporary recognition of multiple standards and decreasing unnecessary costs.[11]

3.15.  Against this background, speakers, in the second round of interventions, discussed how the TBT Agreement principles could contribute to effective regulatory measures in this area, in particular those related to conformity assessment (certification), including the use of equivalence and mutual recognition and what role can the TBT Committee play in this regard.

3.16.  Mr John Jamieson articulated the significant value of the TBT Agreement's disciplines regarding conformity assessment procedures, underscoring their importance in ensuring market coherence and reducing regulatory barriers. Highlighting Australia's longstanding positive experience with reliance mechanisms, he stressed the importance of enhancing international reliance frameworks to minimize divergences, delays, and market disruptions stemming from inconsistent regulatory practices. Mr Jamieson suggested that the TBT Committee actively work to intensify alignment efforts of national regulatory frameworks with internationally harmonized standards and practices, particularly emphasizing cybersecurity, electrical safety, and quality management systems as critical areas where consistency is urgently needed. He further noted that the TBT Committee could expand collaboration and communication channels between regulatory authorities globally, leveraging established forums such as IMDRF, to enhance mutual understanding, streamline regulatory processes, and support coherent global markets for medical devices.

3.17.  Dr Ranga Chandrashekhar underscored the crucial role of the TBT Agreement's disciplines on transparency, harmonization, and equivalence for facilitating international regulatory convergence in the medical devices sector. He emphasized the importance of mutual recognition of conformity assessment results, stressing that regulatory convergence processes remain very slow, with varied regulatory capacities across WTO Members.

3.18.  Dr Chandrashekhar noted that the WTO could significantly accelerate harmonization by developing draft frameworks or guidance documents to assist regulators in progressively achieving convergence through stepwise harmonization and capacity-building. He highlighted the crucial role of trust-building and capacity enhancement among national regulators for advancing effective regulatory cooperation, recommending that the TBT Committee serve as a central forum for dialogue, exchanging experiences, and establishing practical solutions to overcome regulatory divergences.

3.19.  Mr Naoki Morooka emphasized the importance of harmonization disciplines under the TBT Agreement, highlighting how conformity assessment procedures that are based on globally harmonized standards ensure regulatory consistency, reduce market-entry barriers, and support smoother international trade flows. He also noted challenges relating to periodic updates of international standards, noting that inconsistent or staggered implementation timelines across jurisdictions create uncertainty, increase compliance burdens, and inadvertently result in technical barriers to trade.

3.20.  To address these challenges, Mr Morooka recommended that the TBT Committee discuss transition management issues related to updated standards and consider proposing clearer and more synchronized implementation guidance. In this context, he also stressed the importance of improved coordination and proactive communication between standard-setting organizations, regulatory bodies, and industry stakeholders. In addition, he noted that the medical device industry prefers to eventually establish a single window review approach to conformity assessment results, streamlining pre-market approval processes globally.

3.21.  Dr Gideon Too noted that the principles embedded in the TBT Agreement significantly support the development and implementation of effective regulatory frameworks, both nationally and internationally. He underscored that leveraging frameworks, aligned with international standards and IMDRF guidelines, can substantially reduce approval times for medical devices. Furthermore, Dr Too noted that adopting such international frameworks facilitates the regulatory process for health authorities and healthcare professionals, easing their workload in applying consistent regulations across borders. He concluded that the TBT Agreement and aligned frameworks like those of the IMDRF are instrumental for developing Members such as Kenya, enhancing regulatory efficiency, simplifying compliance, and ultimately improving patient access to critical medical technologies.

3.22.  Ms Elaine Grimes highlighted the disciplines under Article 6 of the TBT Agreement, emphasizing Members' obligations to accept results of conformity assessment procedures in other Members when those procedures provide assurance of conformity with applicable technical regulations or standards equivalent to their own procedures. She emphasized that mutual recognition and acceptance of results of equivalent conformity assessment procedures streamline regulatory processes, reduce duplication, and expedite market access for medical devices. Ms Grimes also stressed the importance of ongoing dialogue within the TBT Committee for fostering mutual understanding, transparency, and regulatory coherence among WTO Members.

3.23.  Ms Nada Alkhayat reinforced the critical importance of TBT Agreement principles, such as transparency, proportionality and necessity disciplines, in effectively guiding regulatory interventions, especially given the growing complexity of emerging digital technologies integrated into medical devices. She addressed common misconceptions about regulatory reliance, particularly the understanding that reliance mechanisms diminish regulatory autonomy or negatively affect domestic industries. Based on the EU experience, Ms Alkhayat explained that, in practice, reliance mechanisms strengthen regulatory efficiency, enabling authorities to prioritize high-risk and complex areas without losing sovereign decision-making capability. She also noted that transparency and clear communication are vital for effective implementation of reliance practices. In this context, Ms Alkhayat suggested that the TBT Committee provide targeted guidance and foster open dialogue to dispel misunderstandings around reliance, thus strengthening trust and reliance among WTO Members.

3.24.  Ms Sandra Ligia González discussed concerns regarding whether regulatory reliance might imply a loss of autonomy for national regulatory authorities. Ms González highlighted that despite ongoing international efforts to clearly define and consistently implement the concept of reliance, as per the definition issued by the WHO, variations and differences in interpretation among regulatory authorities persist. She underscored that the ultimate regulatory decision always remains entirely within the domestic regulatory authorities' jurisdiction, safeguarding national autonomy. Ms González further stressed the importance of transparency and access to comprehensive regulatory information for decision-making process by national regulators.

3.25.  Concerning PMS systems, Ms González underlined the need to evaluate the performance, effectiveness, and safety of medical devices after their market approval. She emphasized that, regardless of reliance, final oversight and decision-making power in PMS process rests solely with national regulatory authorities.

3.26.  In closing, Ms González suggested that WTO Members consider formally commit to not develop national regulations or conformity assessment procedures that diverge from internationally recognized standards. In her opinion, such commitment would enhance global regulatory convergence, reduce unnecessary trade barriers, and foster smoother market access for medical devices.

4  comment by the moderator

4.1.  I would like to express my gratitude to the Chair and wider membership for the confidence extended to me to serve as a moderator of the thematic session on regulatory cooperation between Members on Medical Device Regulation. We had an impressive and engaging group of speakers from developed and developing Members as well as the Inter-American Coalition for Regulatory Convergence.

4.2.  I would like to share a few key takeaways from the session:

·_              Speakers emphasized that regulatory cooperation and convergence is essential for ensuring timely access to safe and effective medical devices, particularly in times of public health emergencies. The significant impact of minor divergences in regulatory requirements, such as differences in definitions, risk classifications, or device identification systems, on trade – namely delayed market access – as well as on reduced interoperability of medical devices was highlighted.

·_              It was noted that the IMDRF can play a central role in advancing international convergence, trust-building and cooperation on medical devices. Several speakers referred to the outcomes of the recent 27^th IMDRF session held in Japan — including the establishment of a new international industry group — as a milestone in deepening dialogue between regulators and stakeholders.

·_              The use of international standards (such as those developed by ISO and IEC) was repeatedly highlighted as a foundation for facilitating trade and supporting safety of medical devices.

·_              There was a broad agreement that, to avoid duplication of efforts, regulators could utilize regulatory reliance by, for example, unilaterally granting authorizations for medical devices approved in other countries or establishing bilateral and multilateral recognition systems. In this context, it was noted that regulatory reliance should not be viewed as a loss of autonomy but rather as a strategic tool that enables regulators — especially those with limited resources — to prioritize high-risk areas and streamline market access. Both developed and developing Members shared their experience with utilizing reliance mechanisms, including during the COVID-19 pandemic and HIV responses. As I had noted in the session — this aligns with this Committee's 2024 CAP Guidelines suggestion that regulators may "consider opportunities to rely on the work of other trusted regulators […] in order to make the best use of available resources."

·_              We also discussed how emerging digital technologies (such as AI) transform the medical device sector, with one in four medical devices being themselves software-based or devices enabled by software. These technological developments present valuable opportunities, while also creating complex regulatory challenges in the sector. These include the need to balance horizontal and sectoral regulations and address additional risks (such as cybersecurity or data protection). In this regard, ongoing efforts within IMDRF to address these issues were welcomed.

·_              Post-market surveillance was underscored as a critical component of medical devices regulatory systems. Speakers shared innovative approaches to data collection, healthcare provider engagement, and cross-border cooperation to enhance safety monitoring and real-world performance analysis.

·_              Throughout the discussion, the TBT Agreement's principles — including transparency, harmonization based on international standards, equivalence, and mutual recognition — were cited as key tools to guide regulatory cooperation and reduce unnecessary trade barriers in the area of medical devices. And in this respect — as I noted in the session — this Committee has agreed to hold a thematic session specifically on MRAs across various sectors.

·_              Speakers called for stronger dialogue between trade and health authorities to ensure that health authorities are aware of and comply with relevant disciplines under the TBT Agreement. Speakers also highlighted the importance of promoting good regulatory practices across agencies involved in medical devices regulation to ensure reliance and convergence.

4.3.  I reiterate my gratitude to all our speakers for their insightful contributions, and Members for their active participation in this thematic session. I hope it served as a valuable platform to exchange experiences and practical approaches on regulatory cooperation in this essential sector.

4.4.  I would also like to support a suggestion made by fellow moderator, David Jankowski, that moderators should coordinate on how to spread the time across different thematic sessions, especially when there are disparities in the number of speakers in different sessions.

__________