JAPAN
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Webcasts
- Updates on Japan's Expanding Medical Device Market (May 2009)
- Japan QMS Audit for Medical Device Registration (January 2010)
- Doing Business in Japan (December 2009)
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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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