JAPAN
- Japan has the second largest medical device market in the
world at about $25 billion. The drug market is more than twice as large,
at about $58 billion. Choosing the right business and regulatory strategy
for your medical products is the key to being successful. Pacific Bridge
Medical has a number of expert partners and strategic affiliates located
in our Tokyo office who can successfully assist American and European
medical companies with a number of issues ranging from navigating medical
device and/or drug regulations to building a business strategy.
Recently For Sale
Webcasts
- Strategies for Success in China, Japan, and India (July 2010)
- Japan Medical Device Updates (April 2010)
- Japan QMS Audit for Medical Device Registration (January 2010)
- Doing Business in Japan (December 2009)
Recent Articles
Other Information
- Regulatory Body: Ministry of Health, Labor, and Welfare (MHLW)
- Regulatory Body: Pharmaceuticals and Medical Devices Agency (PMDA)
- Compliance with PMDA/MHLW Regulations
- Device and Pharmaceutical/Drug Master File (MF)
- Quality Management Systems (QMS) with Ministerial Ordinance 169
- Summary Technical Document (STED)
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