Medical Device Single Audit Program (MDSAP) in Japan

The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. 

International partners that are participating in the MDSAP Pilot include:

1. Therapeutic Goods Administration of Australia (TGA)
2. Food and Drug Administration (FDA), USA
3. Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
4. Health Canada
5. Japan’s Ministry of Health, Labour and Welfare (MHLW), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)

Under MDSAP, recognized third-party auditors can conduct a single audit of a medical device manufacturer that will cover ISO 13485 and the respective regulatory requirements of the participating regulatory authorities.

Japan announced its participation to MDSAP Pilot in June 2015. Industry groups in Japan requested for and have supported Japan’s participation to MDSAP Pilot, as it aims to reduce the burden on manufacturers in the QMS inspection processes.

MHLW and PMDA issued guidances about the trial acceptance in June 2016. The current trial program starts from 22nd June 2016 to 31st December 2016.

The complexity of QMS procedures in Japan is high, and the MDSAP trial program can streamline the pathway by saving resources. We at Global Regulatory Partners can help you navigate through the regulatory barriers in Japan and gain market access for medical devices/IVD’s.

For a detailed overview on the MDSAP program for Japan, please click here.

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