Entering the Japanese Medical Device Market : Pre- and Postmarket Regulations
5 May 2011
12:00–1:30pm EDT
Although Japan has tried to harmonize its medical device regulations globally through the Global Harmonization Task Force (GHTF), some of the Japanese medical device regulations are still unique. In addition, while both the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour, and Welfare (MHLW) provide extensive information in English to the public in a timely manner, there are additional regulations available only in Japanese. These make Japanese medical device regulations somewhat complicated.
This RAPS Webcast will provide a comprehensive overview of Japanese medical device regulations. It will include both pre- and postmarket regulations. The premarket regulations will focus on understanding unique Japanese requirements to help companies navigate the challenges in preparing for the launch of their medical devices in Japan. The postmarket regulations will focus on clinical requirements and activities regulated by PMDA and MHLW.
Learning Level(s): Basic, Intermediate
Learning Objectives
Upon completion of this Webcast, participants should be able to:
- Recognize Japanese medical device regulations and common challenges in preparing submissions
- Describe postmarket requirement including Good Postmarketing Study Practice (GPSP）
- Outline when and how to communicate with PMDA during the submission process
Who Should Attend
- Regulatory, marketing, quality and clinical industry representatives
- Anyone involved in medical device development in Japan currently or in the future
Speakers
Takahiro Uchida, MD, PhD, MSc, medical director international, Boston Scientific Corporation, is a skilled interventional cardiologist who received his medical degree from Fukushima Medical University, followed by an MS in epidemiology from Harvard School of Public Health and a doctorate of philosophy in medicine from Tokyo Women's Medical University. He also graduated from the Harvard Business School’s General Management Program. Uchida worked for the Division of Clinical Biometrics at Harvard Clinical Research Institute as a research fellow. Then, he trained at the Japanese Pharmaceuticals and Medical Devices Evaluation Center (currently Pharmaceuticals and Medical Devices Agency), followed by work at the Japan Medical Association to launch a Japanese national clinical trial promotion program as chief medical/operational officer. Uchida also worked as a medical officer/reviewer for the Interventional Cardiovascular Device Branch of Center for Devices and Radiological Health of the US Food and Drug Administration.
Rica Morris, RAC, regulatory affairs consultant, has more than seven years experience in international regulatory affairs, specializing in Japan. She has worked for numerous industry leaders, including Guidant (both in Japan and the US), 3M and American Medical Systems to develop and implement regulatory strategies for Class I–IV medical devices. She is also an adjunct professor in medical device regulatory affairs and services at St. Cloud State University. Morris has chaired several workshops on Japanese regulations.
Cost
Live Webcast Only: Members: $295 USD; Nonmembers: $369 USD
Webcast On-demand Recording Only: Members: $295 USD; Nonmembers: $369 USD
Live Webcast/On-demand Bundle: Members: $395 USD; Nonmembers: $469 USD
Cost is per site - unlimited participants!