G/TBT/GEN/285  
 
24 February 2020  
(20-1406) Page: 1/2 
Committee on Technical Barriers to Trade    
 
THEMATIC SESSION ON GOOD REGULATORY PRAC TICE:  
ENCOURAGING REGULATO RY COMPAT IBILITY AND COOPERATI ON 
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 
 
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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 tech nologies 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 Se ctor, 
Ms. Nancy 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 Sector , 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 convergence 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 (SANTE), European Commission.  
 
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/285  
 
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  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 H ealth, 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, 
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 Automated 
Driving , Mr. Kensuke Suzuki, Deputy Director for Road Transport Policy Planning, General 
Affairs Division, Ministry of Land, Infrastructure, Transport and Tourism of Japan.  
 
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