The Marketing Authorization Holder (MAH) system in Japan came into effect with the new Pharmaceutical Affairs Law (PAL) in April 2005. It was designed to set up a specific structure for companies handling the importation, market release, and postmarket surveillance of medical devices. The MAH structure is separate from the manufacturing process. A foreign company’s Japan office can act as their own MAH, but they must obtain an MAH license for this. Information on MAH options for foreign medical device companies is outlined in Pacific Bridge Medical’s free report, “The New Marketing Authorization Holder (MAH) System for Medical Devices in Japan.”
The main requirement for acting as an MAH is hiring appropriate staff to act as Controllers. In the application, a company must document who their designated Controllers are and how they are qualified for their positions, including their diplomas. This means the hiring must be done before applying. The company must submit a doctor’s certificate that their Controllers have no mental impairment or drug addiction. Other conditions which disqualify an applicant include having in the past three years served a prison sentence, violated the PAL or PAL-related government decisions, or had any medical-related license (such as an MAH) revoked.
Other required documents in the application include:
- Letters of employment for all Controllers
- Information on MAH office, with map showing how to find it
- Copy of official corporate registration
- Chart showing division of duties of members of the board of directors
- Organizational chart of company
- Explanation of company structure showing how it implements Good Quality Practice
- Explanation of company structure showing how it implements Good Vigilace Practice
- Information on storage if conducted in the MAH office (locations of shelves, etc.)
- Floor plan of office, showing locations of labeling, packaging, and storing, if conducted by MAH
- Registration form for Company Code (this will be issued to the company after its application is granted, identifying it as an MAH)
Regarding the company, the application must also provide an organizational chart and overviews of company structure showing how it implements Good Quality Practice and Good Vigilance Practice requirements.
The fees for medical device MAH licenses depend on what medical device classes a company wishes to be licensed for, as well as the prefecture in which the application is made. In Tokyo Prefecture, the fees are: for general (Class 1) medical devices, ¥92,900 (about US$800); controlled (Class 2), ¥128,500 (about US$1,100); and highly controlled (Class 3), ¥146,200 (about US$1,250). It takes at least 35 days to receive approval, and licenses are valid for 5 years.