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PMDA / JIS T0601-1 Medical Device Compliance

Manufacturers of medical devices looking to sell their products in Japan must comply with Japan’s PMDA (Pharmaceuticals and Medical Devices Agency). PMDA is a Japanese regulatory agency, working together with the MHLW (Ministry of Health, Labor and Welfare). PMDA’s obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.

The good news is that the PMDA and MHLW’s primary medical device standard, JIS T0601-1, is a recognized equivalent of IEC 60601-1. Therefore, a manufacturer who has met the requirements of IEC 60601-1 will have met the requirements on JIS T0601-1.

Keystone Compliance can assist medical device manufacturers looking to sell their products in Japan. With our extensive knowledge and experience of IEC 60601-1, we are able to provide the testing and test report to show compliance to JIS T0601-1. Please contact us to allow us to help you meet all of your Japan medical device and JIS T0601-1 testing needs.