Third Party Certification for Low-Risk Medical Devices in Japan: An Update

Japan’s new Pharmaceutical Affairs Law (PAL) will be fully implemented in April 2005. Included in the changes will be the new requirement that all low-risk medical devices, or controlled medical devices, be evaluated by a third party organization. Japan’s┬áMinistry of Health, Labor and Welfare (MHLW) is establishing standards for third party accreditation and specific responsibilities for third party organizations.

The accreditation of third parties will be based on two main standards: the International Organization for Standardization and International Electrotechnical Commission. The MHLW will provide guidance and management to third parties by establishing guidelines for operational standards, duties, confidentiality regulations, etc. They will also conduct audits on the third parties to ensure compliance with the new regulations.

Marketing Authorization Holders (MAHs) will be required to apply directly to a third party certification organization in order to obtain marketing authorization for low risk medical devices. The third party will be responsible for determining whether the MAH medical device is in compliance with the standards of the MHLW. Additionally, through the review of submitted documents and investigation of the production site, the third party will verify the manufacturer’s conformity with quality control standards. If the medical device and manufacturing site is in full compliance with the MHLW regulations, the third party will grant marketing authorization to the MAH.