Formal Acceptance of a MDSAP Report Begins in Japan Early Next Year

The Japanese Ministry of Health, Labor and Welfare issued a notice on September 29, 2021 that stated that Japan has decided to formally start accepting MDSAP reports for medical devices and IVDs as part of the Japanese QMS process for product registration in Japan starting on April 1, 2022.  This was decided in consultation with several Japanese regulatory agencies and industry,  based on the results of the MDSAP trial period that started in 2016.  Generally,  for Japanese QMS, the audit will be either a paper/document-based audit or an on-site audit. However, with an MDSAP report on hand, the QMS audit will only be a paper audit,  with the exception of cell tissue medical devices, radiopharmaceuticals for IVDs, plants that re-manufacture single-use medical devices, etc.

While the MDSAP will help simplify the QMS submission in Japan, it will not replace the QMS requirements in Japan.  Also, since the subsidy provided by the Ministry of Health, Labor and Welfare during the trial period will be terminated early next year, an MDSAP usage application fee ($2,000 per registered factory) will be incurred when applying for MDSAP usage, in addition to the usual government fees for QMS in Japan.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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