Medicinal Products
Market Authorization Holder (MAH)
Foreign manufacturers should appoint a Market Authorization Holder (MAH) as a prerequisite to market drugs in Japan. However, the Pharmaceuticals and Medical Devices Act (PMD Act) allow the appointment of a Designated Market Authorization Holder (D-MAH). In MAH case, the MAH owns and controls the registration and certificate/approval of the drug. In D-MAH case, a foreign manufacturer owns and controls the registration and certificate/approval of drugs, and the D-MAH acts as a representative in Japan. It is ideal to appoint a D-MAH rather than an MAH, as the process of changing a D-MAH is easier than changing the MAH.
Accreditation of Foreign Manufacturer (AFM)
Foreign Manufacturers who plan to manufacture Medicinal products for exportation to Japan must obtain accreditation as an "Accreditation of Foreign Manufacturer ". The Minister of Health, Labor, and Welfare (MHLW) grants accreditation, while the PMDA examines the buildings and facilities of the manufacturing establishment for accreditation. The accreditation is granted for each manufacturing establishment according to the category specified by the Enforcement Regulations.
Medical Devices
Market Authorization Holder (MAH)
Foreign manufacturers should appoint a Market Authorization Holder (MAH) as a prerequisite to market medical devices in Japan. However, the PMDA medical device regulations allow the appointment of a Designated Market Authorization Holder (D-MAH). In the former case, the MAH owns and controls the registration and certificate/approval of the product. In the latter case, the foreign manufacturer owns and controls the registration and certificate/approval of the product and the D-MAH acts as a representative in Japan. It is ideal to appoint a D-MAH rather than an MAH as the process of changing a D-MAH is easier than changing the MAH.
Foreign Manufacturer Registration (FMR)
All the foreign manufacturing companies which intend to export their devices to Japan must register themselves with the Ministry of Health, Labor, and Welfare (MHLW). This registration procedure is called Foreign Manufacturer Registration (FMR), which was formerly known as the “Foreign Manufacturer Accreditation (FMA)” or the “Accreditation of Foreign Manufacturers (AFM).”
Cosmetics
In Japan, only a local entity qualified as a Marketing Authorization Holder (MAH) can import cosmetics into the country. Thus, it is a mandatory requirement for all foreign companies selling in Japan to assign an MAH to manage their cosmetic product registrations and liaise with Japan’s Regulatory authorities. When any cosmetic products are imported and marketed in Japan, the MAH acts as a representative for those products and is responsible for their import and release, as well as their safety and quality assurance on behalf of the foreign cosmetic manufacturers.
The responsibilities and requirements of an MAH are highlighted below:
Responsibilities
- Cosmetic Product Compliance
- GVP & GQP Compliance (Quality and Safety)
- Product Release and Recalls
Requirements
- Office in Japan
- GQP/GVP Conformity