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 $60 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.
Research Library and Current News
- 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)