SMI LLC Services
We provide comprehensive regulatory affairs services for Medical Devices to enter the Japanese market. We advise our clients and support them in preparing application documents / standards applicable / categories and much more. Over the past years we have created the application documents for multiple overseas clients to reach final approval in Japan. Our aim is to let overseas customers test at their original production facility their products and therefore we cooperate with global Notified Bodies to comply with IEC/ISO/CEN and JIS regulations in one test report, to avoid double shipping and testing.
Multiple overseas and local Japanese manufacturers have benefited this service during the past 5 years according to the Pharmaceutical Medical Device Act. (PMD Act.)) and in return according to 510 (k) and MDD directive. With our global network and over 20 years of experience in this field we are your right source when it comes to IPR protection and providing you the service not to disclose company confidential data to distributors and manufacturers in Japan. You as the original manufacturer will control all certifications and documents at your manufacturing site.
Role of a Marketing Authorization Holder (MAH / DMAH)
The Marketing Authorization Holder (MAH), Designated Marketing Authorization Holder (DMAH) must have an appropriate business license obtained according to the Japanese Pharmaceutical Medical Devices Act. from MHLW (Ministry of Health, Labour and Welfare). To receive this license the DMAH must be based in Japan and employ at least three people. A General Manager (MAH Supervisor), a Quality Manager (GQP) and a Safety Manager (GVP). The DMAH submits and maintain the device approval and registration, and after obtaining the PMDA/RCB certification forward them to the manufacturer. When the medical device is approved and is marketed in Japan, the DMAH act as the responsible organization in Japan for GVP (Good Vigilance Practice) and GQP (Good Quality Practice).
The DMAH is the link between the manufacturer and the Japanese Government, and is responsible of different activities concerning the law. Due to that DMAH companies have the obligation to report GVP related issues to the authorities.
●Act as the primary contact point for all Japanese authorities
●Prepare the required documents for the custom clearance of the products in Japan
●Create documents related to the import procedure
●Establish the Quality Standard (Hinshitsuhyojuncho) and create the release criteria for the
market release of the product before shipping it to the distributor
●Establish the Manufacturing Standard (Seizohyojunsho) for labeling, packing and warehousing
●Register JAN Code to MEDIS for each item
●Procure all government import license on behalf of the manufacturer
●Ensure the marketing, quality, and safety standards of the product to be placed on the market
●Report changes in the manufacturing site to authorities
History and differences MAH and DMAH
In 2005 , the Japanese Ministry of Health, Labour and Welfare (MHLW) implemented the new Pharmaceutical Affairs Law (PAL) and this referred to as a Marketing Authorization Holder (MAH) system. In the past, foreign manufacturer of medical devices without a local office in Japan utilized an In-Country Caretaker (ICC) as their agent to import their medical devices to Japan.Meanwhile this law changed to PMD Act. ( Pharmaceutical Medical Device Act )
Under the PMD Act. all foreign manufacturer have to appoint a MAH. Usually the foreign manufacturer appointed his distributor as a MAH. This could cause some trouble in the business if the manufacturer want to change the distributor, or add other distributor, due the MAH is the license holder of the product license. The MHLW has recognized this challenge for foreign manufacturer and included in the PMDL an opportunity to select an independent ‘designated‘ MAH (DMAH). This is called the ‘Foreign Special Approval System ‘under PMDL.PMDL is renewed as PMD Act.
Differences between MAH and DMAH
(MAH : Marketing Authorization Holder /
DMAH : Designated Marketing Authorization Holder)
●The MAH controls the product license of the medical device, he is the applicant and
becomes the owner of the license.
●The MAH need no signature from the foreign manufacturer if a supplement application
or transfer application of the product license is submitted, the MAH is the owner of
the product license, so he can submit the application under their responsibility.
●In a DMAH case, the foreign manufacturer is the applicant and becomes the owner
of the product license. He controls the registration of the medical device.
●Foreign manufacturer cannot easily obtain the license of MAH, so the manufacturer
must appoint a stationed company based in Japan, who has the appropriate
MAH license, and designated it as DMAH.
●The DMAH act as the representative for the foreign manufacturer during and after
the product registration process.
●The application will be submitted from the DMAH to the authorities, but requires the
signature of the foreign manufacturer.
●Every change or supplement application or transfer application of the product license
require the signature of the representative person of the foreign manufacturer.
Submitted via the DMAH to the authorities.
●Change of the DMAH is much easier compare to the case of MAH. Tasks of the
MAH and DMAH are almost the same, such as responsibility for GVP and GQP.
A foreign manufacturer should determine carefully, by considering the environment, his business partner and the situation of his own company.