Regulatory Affairs Professionals Society Webcast to Cover Japanese Medical Device Regulations

May 2011 -- The Regulatory Affairs Professionals Society (RAPS) will host a webcast Thursday, 5 May, that will cover Japanese medical device regulations and offer expert insight for regulatory professionals working with companies entering the Japanese market. Although Japan has tried to harmonize its medical device regulations globally through the Global Harmonization Task Force (GHTF), some Japanese 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. This RAPS webcast will provide an expert overview of Japanese medical device regulations and the clinical requirements and activities regulated by PMDA and MHLW.

Who:

- Takahiro Uchida, MD, PhD, MSc, medical director international, Boston Scientific Corporation

- Rica Morris, RAC, regulatory affairs consultant

What:

90-minute webcast entitled Entering the Japanese Medical Device Market: Pre- and Postmarket Regulations

When:

5 May, 12:00–1:30 pm EDT

How to Access:

Members of the working media may request access to this live RAPS webcast by contacting Zachary Brousseau, senior manager, communications, RAPS, at zbrousseau@raps.org or +1 301 770 2920, ext. 245.

About RAPS

The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org