Japan’s Pharmaceuticals and Medical Devices Agency has been ramping up its regulatory training activities with overseas regulators, and it inviting international regulators to a medical device seminar in Tokyo, Nov. 6-10.
The seminar is intended for medical device and in vitro diagnostic reviewers from overseas regulatory authorities. The event will cover topics ranging from regulations and safety measures to consultations and product reviews. The agency also plans small group discussions among participants.
The agency said 28 regulators from 11 countries participated in a previous seminar in June at the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs in Tokyo. Participants included regulators from Brazil, China, Chinese Taipei, Hong Kong, Malaysia, Myanmar, Philippines, Saudi Arabia, Singapore, Thailand and Vietnam. The program included a site visit to observe a patch manufacturing facility and its quality control measures.
Meanwhile, China and Japan have been in active discussions over device regulations. Officials from the China FDA met with Ministry of Health Labor and Welfare officials in mid-July to discuss how the two countries could strengthen cooperation.