U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. CDRH International Affairs
  4. Medical Device Single Audit Program (MDSAP)
  5. Japan joins the Medical Device Single Audit Program (MDSAP) June 23rd, 2015
  1. Medical Device Single Audit Program (MDSAP)

Japan joins the Medical Device Single Audit Program (MDSAP) June 23rd, 2015

Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are pleased to make the announcement that Japan officially participates in the MDSAP Pilot, which definitely underscores further commitment of MHLW and PMDA  to the international cooperation, including regulatory convergence in this field, with Therapeutic Goods Administration (TGA) of Australia, Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the U.S. Food and Drug Administration.

Through the MDSAP Pilot, MHLW and PMDA are willing to contribute in ensuring appropriate Quality Management System (QMS) and other regulatory requirements are being met by manufacturers, with effective resource allocation, while sharing knowledge and experiences of assessment of auditing organizations with the regulatory authorities, based on the more than 10 year’s assessment experiences in Japan.

As MHLW and PMDA have been active participants in the MDSAP as official observers, MHLW and PMDA believe, with great help of the other participating regulatory authorities, that it is possible to complete a prompt transition in order for the auditing organizations under the MDSAP Pilot to perform an audit with not only the requirements by TGA, ANVISA, Health Canada, and U.S. FDA, but also those by MHLW and PMDA. Once the auditing organizations perform the audits, MHLW and PMDA will utilize these audit reports in both premarket and periodical post market audit under regulations in Japan. Undergoing the MDSAP Pilot audits is expected to reduce some burden on Japanese regulatory processes.

Again, MHLW and PMDA are delighted to make the announcement to become official members and collaborate with TGA, ANVISA, Health Canada, and U.S. FDA, and look forward to working with all the stakeholders.

Back to Top