Designated Marketing Authorization Holder (DMAH)
Service for Medical Device Japanese
◉ Japanese Marketing Authorization Holder (MAH)
Japan’s Pharmaceuticals and Medical Devices Act (PMD Act) defines the Marketing Authorization Holder (MAH) as the legal manufacture in Japan. Consequently foreign manufacturers are not able to wholesale or sell medical device directly to distributors.
The MAH requirements for Quality and Safety control management are strict more than for example ISO 13485, 21 CFR Part 820. The MAH must be located in Japan, formally licensed by the prefectural (regional) government, and employ qualified persons, such as 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).
Japanese Marketing Authorization Holder license is classified to four class and handling medical devices are also different.
◉ Foreign Exceptional Approval System and DMAH
Japan’s Ministry of Health, Labour and Welfare (MHLW) permits manufacturers of Class II, III, and IV medical devices to register their product through the Foreign Exceptional Approval System. This registration route allows the foreign manufacturer to be a Foreign Restrictive Authorization Holder (FRAH), and to register their product under their name, instead of the MAH’s name. And FRAH must appoint a Designated Marketing Authorization Holders (DMAH) who will take regulatory responsibility for activities outlined in the Japan QMS and GVP Regulations stated in PMD Act 72-3.
◉ Marketing Authorization Holder : MAH
・A person who obtains the marketing license. MAH shall supervise and manage the manufacture, and ensure the compliance with QMS of all manufacturing sites. Ensure proper product release to the market. MAH must be in Japan.
◉ Foreign Restrictive Authorization Holder : FRAH
・A foreign manufacture who obtains the marketing approvals of medical devices in foreign country. FRAH may designate licensed MAH in Japan and have it market the product.
◉ Designated Marketing Authorization Holder : DMAH
・MAH designated by FRAH to conduct required quality control duties inside Japan. FRAH shall have DMAH take necessary measures for the prevention of occurrence of hazards to the public health and hygiene in Japan caused by the product.
◉ 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.
◉ GeoMedi is a professional, independent, DMAH Service Provider.
GeoMedi holds a First-Class MAH license and Manufacturer License and Distribution license for medical device issued by Government. As a MAH/DMAH, we import and sell medical devices, and familiar with the know-how of importing, registration, and selling. We have own experience with registration reviews passed through, and has been entrusted with both Regulatory Affair and DMAH by overseas manufacturer.
As your DMAH, we will support:
・Regulatory Affair Consulting (researching class of medical devices/ registration planning)
・Preparing registration application of Foreign Manufacturer
・Preparing application documents for Medical Device and inquiries correspondence from a review authority
・Preparing application documents for Change/Addition/Abolition of registered medical device
・Preparing application documents of Japan QMS Conformity Investigation
・Shipping to the Distributor
・Preparing application documents of insurance coverage for registered medical device
・As import clearance agent
・Assisting adverse event and recall reporting in Japan as needed
Conduct audits of your facility, where applicable. The MAH/DMAH may conduct QMS audits of your facility on the Japanese authority’s request in case of any serious adverse event due to a quality issue.
Of course, we will contact you in advance if you need to renew your registration.
The DMAH is an important partner for your company in Japan who has significant regulatory responsibilities.
When we obtains your registration order, it undertakes regulatory affair and serves as the main point of contact for Japanese regulatory authorities such as Pharmaceuticals and Medical Devices Agency (PMDA) or the Ministry of Health, Labor and Welfare. After obtaining the approval registration, we will storage the final product at our manufacture and manage it from import to shipment. We have an established Quality Management and Safety Management System as a manufacturer & MAH, we are able to save your time and effort to find other consignee for each business.
Please contact us for more information about our Designated Marketing Authorization Holder (DMAH) services.