This WG is to discuss issues including guidelines related to international regulatory harmonization of medical devices.
(Activity period:：From August, 2022 to September 2024)
Activities
The activities conducted over the last five years.
Symposiums
- HBD East 2023 Think Tank Meeting（December 14, 2023）
- HBD East 2021 Think Tank Meeting（January 14, 2022）
Presentations
- Japanese Regulatory Perspective[536KB]/ The Japanese Regulatory Landscape for Venous Interventional Devices[678KB]/ Japanese Regulatory Considerations for Digital Health Technology[946KB]
Vascular InterVentional Advances 2023, Las Vegas, US, November 2023
- Post-market Vigilance and Adverse Event Monitoring for Medical Device[1.44MB]/ Japan’s Regulatory Updates[548KB]
27th GHWP Annual Meeting and GHWP TC Meeting, Shanghai, China, November 2023
- Regulator Perspectives –Importance of Global Harmonization of Requirements[474KB]/ Overview of medical device regulation in Japan[1.34MB]/ Flow of medical device approval review in Japan[722KB]/ Overview of the Regulation of In Vitro Diagnostics products in Japan[680KB]/ Overview of regulations for SaMD and recent challenges in Japan[779KB]
The MedTech Conference 2023, Anaheim, US, October 2023
- Cybersecurity requirements for medical device product registration[1.08MB]/ Remanufactured-Single Use Device in Japan[577KB]
11th Joint Conference of Taiwan and Japan on Medical Products Regulation, Taipei, Taiwan, October 2023
IMDRF - DITTA and GMTA Joint Workshop, Berlin, Germany, September 2023
- The basic concept of review of BTK devices[1.41MB]/ RWD collection to enable rebalancing of the development of medical devices for children and rare diseases[1.16MB]/ Reviewer's approach to the premarket review – PMDA[971KB]
The 31st Annual Meeting of the Japanese Society of Cardiovascular Intervention and Therapeutics, Fukuoka, Japan, August 2023
- Overview of PMDA and Post-marketing safety regulation for medical device in Japan[2.5MB]/ QMS Regulatory System for Medical Device in Japan[0.98MB]/ The latest trends of MDSAP and its acceptance in Japan[1.56MB]
International Regulatory Seminar for Medical Device, Seoul, South Korea, June 2023
- Update on Japanese medical device regulatory initiatives[4.88MB]/ The Pros and Cons of Global Clinical Studies[4.59MB]/ Framework for RWE use in Japan[5.65MB]
Cardiovascular Research Technologies 2023, Washington D.C, US, February 2023
The 9th Thailand - Japan Symposium, Bangkok, Thailand, January 2023
13th China International Medical Device Regulatory Forum, China（Web）, November 2022
- Fundamental concepts of the review regarding SaMD and AI/ML-enabled Medical Devices[1.24MB]/ Achievement and prospective of HBD-for-Children activity[1.16MB]/ Japan SaMD and AI/ML-enabled Medical Devices regulatory framework[1.11MB]
RAPS Convergence 2022, Phoenix, US, September 2022
- Actions to achieve fast patient access to medical devices[663KB]/ RA’s support to COVID-19 related IVDs development[0.97MB]
The 8th Thailand - Japan Symposium, Web, January 2022
- Regulation system and perspective of SaMD[1.03MB]/ Approach to regulation for NGS-based oncology panel products in Japan[2.18MB]
9th Joint Conference of Taiwan and Japan on Medical Products Regulation, Web, October 2021
12th China International Medical Device Regulatory Forum, China(Web), September 2021
- Review process essentials and the experience of reviewing innovated medical devices developed in Japan[2.78MB]/ Regulation system and perspective for SaMD[1.88M]/ Third Party Certification System in Japan -Selection and Supervision of Registered Certification Bodies-[1.55MB]/ Post-marketing Safety Measures of medical devices[2.67MB]/ Regulatory Efforts to Combat COVID-19 in Japan[1.90MB]/ QMS Inspections to Foreign Manufacturing Facilities and Utilization of MDSAP reports[812KB]
RAPS 2021 Convergence, Web, September 2021
- Update from HBD for Children WG[2.33MB]/ Overview of the concept paper for global clinical trials[2.80MB]
Cardiovascular Research Technologies 2021, Web, January 2021