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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【Companies that can apply, etc.】 ■ Companies with a Medical Device Manufacturing and Sales License (MAH) in Japan can apply (The MAH holds product liability under the Pharmaceutical and Medical Device Act for the products) ■ Foreign manufacturers can designate a company with a Medical Device Manufacturing and Sales License (MAH) in Japan as a Dedicated Marketing Authorization Holder (D-MAH), and the D-MAH can apply (Since the company located overseas holds product liability, the D-MAH can be changed through a simple procedure) *For more details, please refer to the PDF materials or feel free to contact us.
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For more details, please refer to the PDF document or feel free to contact us.
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DQS Japan is a specialized organization with a headquarters in Germany and over 30 years of experience. As a partner to Japanese medical device manufacturers, we provide medical device certification services for both Japan and Europe. In Japan, we operate as a registered certification body, conducting certification for highly controlled medical devices and controlled medical devices. For Europe, we serve as the contact point for DQS Medizinprodukte (DQS Medical Devices), which is a Notified Body under the MDR.