The Japanese Ministry of Health, Labour, and Welfare (MHWL) has recently updated the processes and procedures for QMS audit reports of medical device manufacturers and distributors seeking registration for the Japanese market. As Japan has participated in the MDSAP since its inception and is evaluating its usefulness, a trend towards further simplification is emerging. The notification to the MDSAP will come into effect on 1 April 2022.
When it comes to certification for the Japanese market, we are there to support you and explain the important aspects of the regulations. An incorrect application usually leads to long waiting times and additional examinations, blocking access to the important Japanese market.
