How to Access the Japanese Market with Medical Devices <For Foreign Companies>

Helping medical device manufacturers enter the Japanese market! Introducing the medical device approval (certification) steps.

In Japan, the Ministry of Health, Labour and Welfare (MHLW) regulates the manufacturing, sales, and distribution of medical devices. Medical device approval (certification) requires steps such as "application" and "QMS conformity assessment." Additionally, all application documents and technical documentation must be prepared in Japanese. The DQS Group can assist manufacturers of medical devices entering the Japanese market by dividing roles, so please feel free to contact us when needed. 【Medical Device Approval Steps (Partial)】 ■ Search for the general name of the medical device for which approval is sought, and examine the approval criteria and the status of existing devices in Japan to consider application methods and identify technical issues. ■ Select the applicant (MAH or D-MAH) and prepare the application. ■ Submit the application for medical device certification. ■ Conduct QMS conformity assessment. *For more details, please refer to the PDF materials or feel free to contact us.

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