G/TBT/GEN/287  
 
12 March 2020 
(20-1962) Page: 1/6 
Committee on Technical Barriers to Trade    
 
THEMATIC  SESSION ON GOOD REG ULATORY PRACTICE:  
ENCOURAGING REGULATO RY COMPATIBILITY AND  COOPERATION1  
25 FEBRUARY 2020, 10 :00-13:00  
Moderator's Report2  
The Moderator of the Thematic Session on Good Regulatory Practice  delivered this Report at the 
WTO TBT Committee's meeting of 26 -27 February 2020.  
 
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At the Eighth Triennial Review, Members agreed to continue to hold thematic sessions in conjunction 
with its regular meetings during 2019 to 2021, with a v iew to further deepening the Committee's 
exchange of experiences on specific topics, and to hold a session on good regulatory practice (GRP) 
in February 2020 with a focus on: Encouraging regulatory compatibility and cooperation.3 The 
programme for the them atic session is contained in the Annex of this report. The presentations 
summarized below are available through the WTO website.4  
 
Panel 1: Medical devices  
1.1.  Ms Melissa Torres5 (United States) described examples of regulatory cooperation in the 
medical devices sector: the International Medical Device Regulators Forum (IMDRF); and the Medical 
Device Single Audit Program (MDSAP). The IMDRF seeks to accelerate international medical device 
regulatory convergence, while addressing common public health  regulatory challenges and 
supporting innovation. The IMDRF is comprised of regulatory authorities of the ten Management 
Committee members6 and includes participation of observers and regional harmonization initiatives 
(e.g. APEC and the Asian Harmonisatio n Working Party), which extends participation to additional 
regulatory authorities. There are eight IMDRF working groups, which develop harmonized 
documents, procedures, or regulatory harmonization programs, thereby promoting greater 
regulatory alignment a mongst IMDRF members. One example of an output of IMDRF work was the 
Medical Device Single Audit Program (MDSAP ), which includes participation of five members7, two 
affiliate members8, and two observers9. MDSAP does away with the need for multiple audits o f 
manufacturers, by allowing recognized "Auditing Organizations" to conduct a single on -site audit of 
a medical device manufacturer that will satisfy the relevant requirements of five participating 
Regulatory Authorities. MSDAP minimizes regulatory burden on industry, promotes more efficient 
and effective use of regulator resources, enhances global alignment of regulatory approaches and 
technical requirements, and ensures consistency, predictability and transparency for manufacturers. 
 
1 The final programme was circulated as G/TBT/GEN/285 . It is also in Annex I of this document.  
2 Ms Renata Cristaldo (Paraguay). This R eport is provided on the Moderator's own responsibility.  
3 G/TBT/41 , para. 8.2.a.iv, footnote 300; JOB/TBT/350 . 
4 https://www.wto.org/english/tratop_e/tbt_e/thematic_session_standard_121119_e.htm  
5 Associate Director for Internatio nal Affairs, Office of the Center Director, Center for Devices and 
Radiological Health, US Food and Drug Administration  
6 Australia, Brazil, Canada, China, the European Union, Japan, Russian Federation, Singapore, Korea, 
and the United States  
7 Australia, Brazil, Canada, Japan, US  
8 Argentina and Korea  
9 EU and WHO  G/TBT/GEN/287  
 
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  More than 5,100 medica l device manufacturing sites participate in the program, and the audit model 
is publicly available, further contributing to predictability and transparency.  
1.2.  Ms Nancy Shadeed10 (Canada) outlined the context for regulatory cooperation in the medical 
devices s ector, which includes fast paced technological development, very rapid regulatory reviews 
for market approval, and a wide diversity and complexity of technologies which pose challenges for 
regulators. Canada cooperates with partners through the IMDRF and t he MDSAP, which help to 
accelerate harmonization and convergence building. IMDRF documents developed by its working 
groups were increasingly being adopted by regulators, including in Canada. For instance, the working 
group on Adverse Event Terminology deve lops harmonized terminology and systems to code 
information about adverse events, which ensures that when safety situations do arise regulators are 
using the same coding and avoid discrepancies, to enable international tracking and trending of 
adverse even ts. Health Canada will adopt the IMDRF Adverse Event Terminology later in 2020, and 
other jurisdictions are doing the same. Another example was Health Canada accepting the IMDRF 
Common Table of Contents for Medical Device Regulatory Submissions in 2019, wh ich ensures that 
regulators in different countries will receive the same package of information in submissions, 
facilitating regulator -to-regulator discussion. She explained how the MDSAP took several years to 
develop and was built from an initial pilot be tween the US FDA and Health Canada. This pilot proved 
that a single audit could work and satisfy requirements of both countries, and led to discussions with 
Australia, Japan and Brazil to eventually create the single audit program. The MDSAP global approac h 
pools technology, resources, and services to improve the safety and oversight of medical devices on 
an international scale, while benefiting manufacturers. Reviewing and evaluating novel devices in an 
agile manner is a key challenge for regulators, and t here is a continued need for international 
collaboration to deliver solutions that provide market access and health and safety for patients 
worldwide.   
1.3.  Ms Renata Amaral11 (United States)  introduced the Inter -American Coalition for Regulatory 
Convergence, wh ich is composed of medical technology associations of the Western Hemisphere and 
other private and public sector stakeholders. The coalition will be launched in March 2020 in Mexico 
City, with the aim of promoting regulatory cooperation across the Western Hemisphere to achieve 
internationally aligned medical technology regulations, standards and conformity assessment 
requirements. In this respect, some of the key challenges facing the medical devices sector include: 
the enormous diversity of products and th erefore diversity of standards and regulations; the multiple 
sites involved in the manufacturing of a single medical device and the need for multilingual/multi -
country labels; and the very complex and lengthy registration processes which vary between 
count ries. Two key regulatory and trade challenges are that medical device regulators are not aware 
of the TBT Agreement or are not required to implement its provisions by trade ministries, and that 
medical devices are often improperly regulated as drugs. She h ighlighted the importance of medical 
device regulations applying key elements of GRP, including stakeholder engagement; reliance on 
quality data and sound science when introducing new regulation, impact analysis of proposed and 
implemented regulations; use  of international standards; and transparency such as regulatory 
forecasting. In this respect, she said the US -Mexico -Canada Agreement  (USMCA) Chapter on Good 
Regulatory Practices represents the state of the art in codifying GRP in a trade agreement, and t he 
USMCA Sector Annex on Medical Devices provided important benefits for industry. In addition, the 
TBT Agreement and TBT Committee provide a unique framework for international regulatory 
cooperation contributing to easing trade frictions through, for exam ple, the notification of draft 
measures, harmonization with international standards, and discussion of specific trade concerns.  
1.4.  Mr. Erik Hansson12 (European Union) spoke about efforts in the EU to support global 
regulatory convergence in the field of medical devices. He said that medical devices are a challenge 
to regulate: they cover a very wide area or products (over 500,000 types of medical device s on the 
market), are important economically (over 500 000 people employed in the EU – with about 25,000 
companies) – and with significant annual sales (€500 billion). From a global perspective, the main 
features from a regulatory point of view are similar , there are three main stages: 1) the pre -market 
stage; 2) the on -market stage (labelling) ; and 3) the post market phase (about ensuring the 
continued safety and effectiveness of device).  The "New Approach " applie s to these regulations. This 
 
10 Manager, International Programs Division, Office of Policy and International Programs, Medical Device 
Directorate, Health Canada  
11 Visiting Scholar - American University Washington College of Law, Technical Secretariat – Inter-
American Coalition for Regulatory Convergence for the Medical Technology Sector  
12 Deputy Head of Unit, Directorate -General for Health and Food Safety (SANTE), European Commission  G/TBT/GEN/287  
 
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  mean s that ess ential requirements set out safety and performance requirements which are then 
implemented through harmonized (voluntary) standards. CE marks indicate that requirements are 
met, and conformity was done through third party assessment (by notified bodies). F or market 
surveillance, much emphasis is put on market surveillance under the responsibility of member 
States.  Two new EU Regulations were described which are aimed at increasing the protection of 
patients and health. These regulations, Mr. Hansson said, provide more transparency, support 
innovation and improve requirements for clinical data and evaluation. It was stressed that the EU 
single market for medical devices include s, aside from the EU, also EFTA/EAA, Turkey and 
Switzerland. At a global level, it  was noted that a WHO survey (2015/16) show ed that 58 % of 
countries ha ve regulations, 27% have none and 15% did not provide an answer to the survey. Mr 
Hansson then spoke of the International Medical Device Regulators Forum (IMDRF). This Forum, he 
said, ha s a mission to achieve more convergence. Membership of the forum comprise s several 
countries13, has several work items, including, for example: good regulatory review practices, quality 
of standards for regulatory use, and cybersecurity. Mr. Hansson provide d a few examples of the 
results of this work and stressed, among other things, that this work was informal, non -binding, 
flexible, quick , and involve s the establishment of best practices. Several new EU regulations are 
based on IMDRF principles.  
1.5.  Mr. Minoru Iijima14 (Japan) spoke about regulatory cooperation on medical devices. While 
medical devices ha ve been rapidly globalized, each regulatory authority ha s developed different 
regulations, including definitions, categorizations, quality, non -clinical a nd clinical requirements; this 
could result in overlap and deviation. It was important that each regulatory authority had the 
resources and capacity to keep up with rapid technical developments. Regulatory authorities around 
the world need to promote harmo nization and reliance on common international standards. In this 
regard, WHO work s on the regulatory system strengthening for medical products and promote s 
regulatory cooperation to strengthen capacity of national regulatory authorities. He explained the 
role of Japanese regulatory authorities including the Pharmaceutical Safety and Environmental 
Bureau (MHLW) and the Pharmaceutical and Medical Devices Agency (PMDA), the Japanese approval 
and certification system for medical devices, and risk -based classifi cation of medical devices. Japan 
is a member of the IMDRF and is participating  in the  Medical Device Single  Audit Programme 
(MDSAP) , describing the benefits of its use from the view of both importing and exporting 
manufacturers. In addition, Japan has been providing capacity building seminars for other regulatory 
authorities through PMDA -Asia Training Centre.   
Panel 2: New vehicle technologies  
1.6.  Ms Ivone Kaizeler15 (European Commission) spoke about the UNECE World Forum for the 
harmonization of vehicle reg ulations : the WP.29. The presentation was essentially an example of 
how international guidance (work at UNECE WP.29) is used in EU legislation. In the automotive area, 
she said, this was about drafting regulations – based on international guidance – essent ially for 
safety and environmental objectives. Before placing vehicles on the market, third party mandatory 
conformity assessment is required – or, "type approval ". Three UNECE agreements had been 
adopted that establish regulatory measures for motor vehicl es and motor vehicle equipment : the 
(i) the 1958 Agreement – UN Regulations; (ii) the 1998 Agreement - United Nations Global Technical 
Regulations (UN GTRs); and (iii) the 1997 Agreement - UN Rules (periodical technical inspections). 
Ms Kaizeler focused on  the 1958 Agreement, which sets out uniform technical prescriptions for 
wheeled vehicles, equipment and parts and the conditions for reciprocal recognition of approvals – 
in around 150 regulations and over 60 contracting parties. These regulations govern, among other 
things, safety and environmental aspects. The 1958 Agreement is essentially, she said, a mutual 
recognition agreement done at the multilateral level with rules considered relevant under Article 2.4 
of the TBT Agreement. The regulations were app licable to the EU – meaning that most of them are 
binding in EU law through incorporation of a reference in EU legislation. It was noted that automated 
and connected vehicles is an area that is not yet fully regulated. Several issues would need looking 
into, including how to assess new technologies such as automation, software updates, cybersecurity, 
event data recorders (accidents), awareness of "vulnerable road users' proximity" , and measuring 
emissions . These were areas w here several countries are active  but there is no definitive regulation 
yet. In sum, UNECE work was a good, international forum to find ways and means of reducing 
 
13 http://www.imdrf.org/about/about.asp  
14 Ministry of Foreign Affairs, Ministry of Health, Labour and Welfare, Japan.  
15 Team Leader, Automotive Unit, Directorate -General for Internal Market, Industry, Entrepreneurship 
and SMEs  G/TBT/GEN/287  
 
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  unnecessary technical barriers to trade, to ensure equivalent standards of safety and environmental 
performance – thereby ensu ring high level of consumers protection and at the same time making 
life easier for manufacturers and regulators.  
1.7.  Mr. Kensuke Suzuki16 (Japan)  spoke about Japanese policy on automated driving and its 
contribution to the international activities in this area . Mr Suzuki noted that automated driving is 
expected to significantly decrease traffic accidents caused by drivers ' error. In Japan, up to 95% of 
accidents were due to driver error (in 2018) – thus there was significant scope for reducing mortality 
and inj ury with more automation. Also, automated driving could help Japan overcome challenges 
related to the shortage of professional drivers. There were several levels for automated driving, 
ranging from simple driving assistance (staying on the lane) to fully a utomated driving (the system 
performed the full driving). Mr Suzuki then explained the government's strategy to develop 
increasing automated driving towards 2025 which would, inter alia , reduce accidents, encourage 
innovation and enable societal goals (fre e movement of elderly). To realize these goals, it would be 
necessary to develop national laws compatible with automated driving – this included an amendment 
to the Road Vehicle Law (passed and enacted in May 2019). This included, for example, the domestic  
adoption and implementation of specific technical requirements set out in UNECE WP.29. Thus, at 
the international level, Japan was contributing to discussion held in the UNECE with the objective of 
promoting internationally harmonized regulations to the b enefit of car manufacturers and consumers 
(motor vehicle users) in every country. This was a good way of collaborating at the international 
level because it was a more effective rule -making process. Indeed, G7 transport ministers, in a joint 
declaration (J une 2017 in Cagliari , Italy) had reaffirmed their commitment to identify and remove 
potential barriers to the introduction of automated guidance technology – and to cooperate on 
existing regulation systems at international and country levels . 
COMMENT BY MO DERATOR  
1.8.  On a personal note, the Moderator  made the following remarks.  
1.9.  Finally , let me make a few personal remarks. The presentations were useful in that they 
highlighted the application of good regulatory practices and regulatory cooperation in two very 
different sectors: medical devices and new vehicle technologies. In both cases,  the importance of 
cooperation between regulatory authorities was emphasized, including through development of 
guidance and best practices at the international level, such as through the IMDRF for medical 
devices, or through work in UNECE for cars. The imp ortance of cooperating – particularly in the area 
of new technologies – where regulation has not yet developed, was emphasized. We heard about 
the importance of using relevant international standards to promote regulatory convergence in 
approaches to regul ating new technologies. Several presentations also emphasized the importance 
of following the principles of the TBT Agreement to ensure the avoidance of unnecessary barriers to 
trade while allowing regulations to achieve legitimate objectives in these two sectors, including the 
protection of human safety, as well as the environment. The use of good regulatory practices was 
highlighted, such as transparency, ensuring a scientific basis for regulation, impact analysis, and 
ensuring participation of all releva nt stakeholders in the development of regulation. The discussion 
showed how regulatory cooperation in specific sectors can help regulators better meet public policy 
objectives with fewer resources, while also reducing burdens on industry.  
  
 
16 Ministry of Land, Infrastructure, Transport and Tourism in Japan  G/TBT/GEN/287  
 
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  ANNEX  
 
THEMATIC SESSION ON GOOD REGULATORY PRAC TICE:  
ENCOURAGING REGULATO RY COMPATIBILITY AND  COOPERATION  
25 FEBRUARY 2020 , 10:00 -13:00  
Programme1 
At the Eighth Triennial Review, Members agreed to continue to hold thematic sessions in conjunction 
with its regular meetings during 2019 to 2021, with a view to further deepening the Committee's 
exchange of experiences on specific topics, and to hold a se ssion on good regulatory practice  (GRP) 
in February  2020 with a  focus on: Encouraging regulatory compatibility and cooperation .2 
 
_______________  
 
 
This thematic session  will be  moderated by  Ms Renata Cristaldo (Paraguay) . 
 
Guiding questions:  
• What are the key regulatory compatibility and cooperation challenges in the medical 
devices/new vehicles technologies sectors?  
• What approaches to regulatory cooperation are most effective in promoting regulatory 
compatibility in the medical devices/new vehicle technolo gies sectors?  
 
 
Panel 1: Medical devices  
a. United States : Examples of Regulatory Cooperation in the Medical Device Sector: The 
International Medical Device Regulators Forum (IMDRF) and the Medical Device Single 
Audit Program (MDSAP) , Ms. Melissa Torres, Associate Director for International Affairs, 
Office of the Center Director, Center for Devices and Radiological Health, US Food and 
Drug Administration.  
b. Canada : Canada's Experience in Regulatory Cooperation in the Medical Devices Sector , 
Ms. Nanc y Shadeed, Manager, International Programs Division, Office of Policy and 
International Programs, Medical Device Directorate, Health Canada.  
c. United States : Good Regulatory Practices, Technical Barriers to Trade and the Impact for 
the Medical Technology Sec tor, Ms Renata Amaral, Visiting Scholar - American University 
Washington College of Law, Technical Secretariat – Inter-American Coalition for 
Regulatory Convergence for the Medical Technology Sector.  
d. European Union: Efforts to support global regulatory con vergence in the field of medical 
devices and mechanisms for exchange of post market safety information on medical 
devices with global distribution , Mr. Erik Hansson, Deputy Head of Unit, Medical Devices, 
Directorate -General for Health and Food Safety (SANT E), European Commission.  
e. Japan : Regulatory Cooperation on Medical Devices , Mr. Minoru Iijima, Deputy Director for 
International Trade division, Economic Affairs Bureau, Ministry of Foreign Affairs of Japan, 
(on behalf of Ministry of Health, Labour and Welfare, Japan) . 
Panel 2: New vehicle technologies  
a. European Union: UNECE World Forum for the harmonization of vehicle regulations – a 
global standard bearer and blueprint for EU legislation , Ms Ivone Kaizeler, Team Leader, 
 
1 The draft programme is contained in JOB/TBT/354/Rev.1 . 
2 G/TBT/41 , para. 8.2.a.iv, footnote 300; JOB/TBT/350 . G/TBT/GEN/287  
 
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  Automotive and Mobility Industries, Directorate -General for Internal Market, Industry, 
Entrepreneurship and SMEs (GROW), European Commission.  
b. Japan : Japanese Policy and contribution to the International Activities on Autom ated 
Driving , Mr. Kensuke Suzuki, Deputy Director for Road Transport Policy Planning, General 
Affairs Division, Ministry of Land, Infrastructure, Transport and Tourism of Japan.  
__________