ANSWERED ON THIS PAGE:
- What is the difference between an MAH and a D-MAH?
- How do I maintain control of my device registration in Japan?
- Can I use my distributor as my MAH/D-MAH?
Japan's Pharmaceuticals and Medical Devices Act (PMD Act) requires all medical device and IVD companies with no location in Japan to appoint a licensed in-country representative known as a Marketing Authorization Holder (MAH). The MAH represents your company to Japanese regulatory authorities, and is responsible for ensuring the marketing, quality, and safety of products placed on the market.
Requirements for obtaining a Japan MAH License
The Marketing Authorization Holder (MAH) requirements are strict, much more so than a European Authorized Representative or US Agent. Your MAH must be based in Japan, formally licensed by the prefectural (regional) government, and employ a General Manager, Quality Manager, and a Safety Manager.
MAHs must also implement a quality management system based on MHLW Ordinance No. 169 and Good Vigilance Practices (GVP). Beyond having their name on your device labels, your MAH/D-MAH is responsible for the quality and safety of your products marketed in Japan so selecting a qualified partner is important.
Difference between an MAH and a D-MAH
Japan's Ministry of Health, Labour and Welfare (MHLW) permits manufacturers with no location in Japan to register their own Class II, III, and IV devices through the Foreign Special Approval System (FSAS). This registration route allows the manufacturers to own the registration of their product under their own name, instead of the MAH's name. In this case, the manufacturer bears full responsibility as MAH, and the appointed MAH is referred to as a Designated MAH, or D-MAH, as they do not own your device registration. Your D-MAH carries some of the same responsibilities that foreign manufacturers are deemed unable to adequately perform, such as final shipment release judgements and vigilance. This is a big decision so be sure to read the Frequently Asked Questions section below.
Japan MAH/D-MAH representation options available to foreign medical device manufacturers
If you have a subsidiary in Japan ...
Your subsidiary can obtain a MAH license and act as your MAH or D-MAH.
If you do NOT have a subsidiary in Japan ...
- You can engage a distributor with a MAH license and obtain marketing approval under their name. If you choose this option, your distributor will have complete control of your products in Japan.
- You can designate your distributor as your D-MAH and obtain marketing approval under your company name through the FSAS. However there are drawbacks to this option. Ask us for details.
- You can designate a third party or regulatory consulting firm like Emergo as your D-MAH. This option gives you the most flexibility.
Emergo is a professional, independent, D-MAH with offices in Tokyo
Emergo Japan holds a Type 1 MAH license from the Tokyo Metropolitan Government. Our goal is to help you maintain full control over your devices in the Japanese market. As your D-MAH, we will:
- Ensure the marketing, quality, and safety of your products.
- Act as your primary contact point for all Japanese regulatory authorities including the PMDA and MHLW.
- Assist in incident reporting in Japan as needed.
- Communicate with your distributor(s) to create your import procedures, prepare your import submissions, and clear products through Japanese customs.
- Communicate with your registered Japanese manufacturer in charge of warehousing of the final product to develop the Quality Agreement and prepare Medical Device File (Seihinhyojunsho) for receiving inspection, labeling and warehousing as applicable.
- Conduct audits of your facility, when applicable. (The MAH/DMAH may conduct QMS audit to your facility on the authority's request in the case of any serious adverse event due to a quality matter)
- Assist with regulatory amendment procedures for product design or manufacturing establishment changes as applicable.
The D-MAH is an important partner for your company in Japan, with significant regulatory responsibilities. Appointing Emergo as your independent D-MAH may make more sense than selecting your distributor to fulfill this role.
Please contact us for more information about Designated Marketing Authorization Holder (D-MAH) services for Japan.