Designated Marketing Authorization Holder (DMAH) Service

Japanese Designated Marketing Authorization Holder (DMAH)

Japan’s Pharmaceuticals and Medical Devices Act (PMD Act) defines the Marketing Authorization Holder (MAH) as the legal manufacture in Japan.The MAH requirements are strict, much more so than for example a European Authorized Representative or US Agent. The MAH must be based in Japan, formally licensed by the prefectural (regional) government, and employ qualified persons, i.e.  a General Manager, a Quality Manager and a Safety Manager. MAHs must also implement a quality management system based on MHLW Ordinance No. 169 (Japan QMS Regulation) and Good Vigilance Practices (GVP). If a manufacturer does not have a place of business in Japan, it may appoint its distributor as the MAH. The MAH will maintain its device approval and registration in their name and therefore selecting the distributor as the MAH implies that the distributor will obtain full control over the manufacturer’s device and market commercialization.

Foreign Special Approval System (FSAS) and DMAH

Japan’s Ministry of Health, Labour and Welfare (MHLW) permits manufacturers of Class II, III, and IV devices to register their product through the Foreign Special Approval System (FSAS). This registration route allows the foreign manufacturer to register their product under their name, instead of the MAH’s name, i.e. foreign manufacturer can be a quasi MAH, and they must appoint a Designated Marketing Authorization Holders (DMAH) who will take regulatory responsibility for activities outlined in the Japan QMS and GVP Regulations.

Why select an Independent DMAH versus a distributor as the MAH?

While it is possible to appoint a distributor as the MAH (Distributor MAH) in Japan, there are many reasons why selecting a distributor as your MAH should be reconsidered, including

  • The Distributor MAH controls your device approval which gives them full control over your device approval in Japan.

  • Selecting an independent DMAH allows flexibility in the selection of distributors and allows for more control over those distributors and their networks. It prevents that your distributor has full control over the commercialization of your devices in Japan.

  • If you decide to change distributors, you may have to re-register your devices again for approval. This is costly, time consuming and may result in being (temporarily) off the market until you have obtained new approval.

  • The MAH/DMAH must have full access to your device technical information, which may include proprietary design information. The DMAH is capable of keeping this information confidential and prevents the necessity of sharing this information with  a distributor.

  • In the event there are reportable incidents or  non-compliances are raised by Japanese authorities with regard to your devices placed on the Japanese market, will l your distributor as the selected MAH defend his company’s interests or yours?

  • Often distributors are not trained, experienced or aware of the responsibilities that come with being a MAH and therefore may not represent you as needed.

Located in Aichi, SMI LLC is a professional, independent, DMAH Service Provider.

SMI LLC holds a Type Ⅱ MAH license for medical device issued by the Aichi Prefecture. Our goal is to help you maintain full control over your devices in the Japanese market, both from a regulatory and commercialization perspective. As your DMAH, we will:

  • Ensure that the Marketing, Quality, and Safety Standards are upheld.

  • Act as your primary contact point for all Japanese regulatory authorities, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labour and Welfare (MHLW).

  • Assist in adverse event and recall reporting in Japan as needed.

  • Communicate with your distributor(s) to create your Import Procedures, and clear products through Japanese Customs.

  • Assist in your behalf  the Japanese Registered Warehousing Manufacturer (your warehouse provider of the final product in developing the Quality Agreement (Torikimesho) and prepare the Medical Device File (Seihinhyojun–sho) for labeling and warehousing, where applicable.                                                                     

The DMAH is an important partner for your company in Japan who has significant regulatory responsibilities. By appointing Micren Healthcare as your independent DMAH you will maintain regulatory and commercial independence from your distributor(s).

Please contact us for more information about our Designated Marketing Authorization Holder (DMAH) services.