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Latest update : 14.06.2013
Access to the Japanese market
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Access to the Japanese market

Certification within the framework of Japanese regulation

Regulatory framework

The marketing of a medical device on the Japanese market needs to be in conformity with the requirements of the Pharmaceutical Affairs Law (JPAL). To be in conformity, quality management system audits (QMS) need to be conducted by the JPAL authorized bodies.

Thanks to a Recognition Agreement with the Japan Quality Assurance organization (JQA) for your medical devices, LNE/G-MED conducts the initial audit of the quality system and the follow-up or renewal audits recognized by the JPAL.

To learn more on the marketing of medical devices in Japan, see our “Registration of Medical Devices in Japan” guide


For information on the LNE/G-MED certification process, see the section Obtaining certification

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