Accreditation of foreign manufacturers of medical devices
Overseas manufacturers intending to manufacture drugs, quasi-drugs or medical devices overseas for export to Japan require MHLW accreditation in the same way as Japanese manufacturers are licensed. MHLW has the authority to grant accreditation to overseas manufacturers, while PMDA examines buildings and facilities of manufacturing establishments for accreditation, which is granted to individual manufacturing establishments according to the category specified by the Enforcement Regulations. A Japanese Marketing Authorization Holder (MAH) that markets drugs and medical devices made by overseas manufacturers can submit accreditation applications on their behalf. However, the name of the applicant on the application form should be the overseas manufacturer’s name.
Under the PAL, product approval application and product certification can be implemented under the manufacturer’s name instead of that of the distributor or subsidiary. The overseas manufacturer assigns a Japanese distributor with a MAH license as the Designated MAH (DMAH), and then puts together/submits the application for approval/certification through the DMAH. In such cases, the overseas manufacturer owns the approval/certification, and the DMAH company works as an agent in Japan. A major advantage of this method is that the distributor can be selected/changed after regulatory approval/certification of the product.