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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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Reports

  • Japan Quality Audits 2010
  • Contract Research Organizations in Asia 2010

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Recent Articles

Publications

  • Japan Audit and Accreditation for Foreign Medical Device Manufacturers
  • Medical Device Reimbursement in Japan

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News Briefs

  • Japan Dispatches Liaison to Washington D.C.
  • China-Japan-Korea Working Group (WG) on Drug Clinical Trials
  • Increased Cooperation between Japan, EU, and Canada for Medical Device Regulations
  • US and Japan Commit to Regulatory Reform and Economic Cooperation

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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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