Celebrating 10 years of innovative, global,
Regulatory solutions & services for Life Sciences industry

Local Representation in Japan

Market Authorization Holder (MAH)

Foreign manufacturers should appoint a Market Authorization Holder (MAH) as a prerequisite to market drugs in Japan. However, the PMDA 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 drug. In the latter 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.

Foreign Manufacturer Registration (FMR)

All the foreign manufacturing companies that intend to export their drugs 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).”

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
Quick Inquiry
x