Good Regulatory Review Practices

Working Group Chair(s)
Dr Kenneth Cavanaugh
Food and Drug Administration (US FDA)
United States of America
Lai Peng Low
Health Sciences Authority (HSA)
Singapore
Membership
Regulators
Status
Current

The charter of the Good Regulator Review Practices (GRRP) working group is to develop guidance that establishes good regulatory review practices for regulatory authorities and/or their conformity assessment bodies.

The Review Practices (GRRP) working group aims to improve the effectiveness and efficiency of pre-market review. The GRRP working group has produced documents to support pre-market review including those listed below.

Essential Principles of Safety and Performance Workshop

On 11 and 19 September, 2024, the IMDRF organized a two-part workshop focused on building Medical Device National Regulatory Authority (NRA) capacities and awareness of the IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, for current and prospective IMDRF Affiliate Members. This two-part workshop took place in conjunction with the U.S. Food and Drug Administration (USFDA) hosting of the IMDRF meetings.

The workshop was led by representatives of the NRA member bodies of the IMDRF Management Committee joined by select medical device industry representatives to provide real-world perspectives of the application and benefits of the Essential Principles as a cornerstone of effective medical device regulatory frameworks. This workshop was meant to serve as an introductory overview of the topics upon which future IMDRF training sessions may expand.

The recordings and materials shared during the sessions are available from the Medical Device Convergence Project (MDRC) website, IMDRF Training page. 

 

Technical/Informational document

Participants

Boussuge Salvador María Candelaria
National Administration of Drugs, Food and Medical Devices (ANMAT)
Cecilia Carrón
National Administration of Drugs, Food and Medical Devices (ANMAT)
Gabriel Schugurensky
National Administration of Drugs, Food and Medical Devices (ANMAT)

Jie Zhou
Therapeutic Goods Administration (TGA)
Sushil Khatri
Therapeutic Goods Administration (TGA)

Augusto Bencke Geyer
Brazilian Health Regulatory Agency (ANVISA)

Catherine Milley
Health Canada
Maria Carballo
Health Canada

Shiqing Zhang
National Medical Products Administration (NMPA)
Yuxi Yang
Center for Medical Device Evaluation (CMDE)

Aleksandra Rodatus-Gil
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Poland
Mairead Finucane
European Commission
Maria-Chiara Orlandi
European Commission
Mario Gabrielli-Cossellu
European Commission
Patrick Murphy
Health Products Regulatory Authority (HPRA), Ireland

Aoyagi Yumiko
Ministry of Health, Labour and Welfare (MHLW)
Dr Koichi Aizawa
Pharmaceuticals and Medical Devices Agency (PMDA)
Dr Madoka Murakami
Pharmaceuticals and Medical Devices Agency (PMDA)
Takehiro Ichikawa
Pharmaceuticals and Medical Devices Agency (PMDA)

Laith Al Helo
Jordan Food And Drug Administration (JFDA)
Neda Al Shaer
Jordan Food And Drug Administration (JFDA)

Vladimir Antonov
Federal Service for Surveillance in Healthcare (Roszdravnadzor)

Lai Peng Low
Health Sciences Authority (HSA)

Soonyeong Park
Ministry of Food and Drug Safety (MFDS)

Ms Michal Neukamp
Swissmedic
Simone Frank
Swissmedic

Madhavan Srinivasan
Medicines and Healthcare products Regulatory Agency (MHRA)
Rob Higgins
Medicines and Healthcare products Regulatory Agency (MHRA)

Dr Kenneth Cavanaugh
Food and Drug Administration (US FDA)
Melissa Torres
Food and Drug Administration (US FDA)

Deirdre Healy
World Health Organization (WHO)
Irena Prat
World Health Organization (WHO)
Mark Lanigan
World Health Organization (WHO)