D-MAH - Designated Marketing Authorization Holder (MAH) services
In the past, foreign medical device companies without a local office in Japan utilized an In-Country Caretaker (ICC) as their agent to export their products. In 2005, the Japanese Ministry of Health, Labour and Welfare (MHLW) implemented the new Pharmaceutical Affairs Law (PAL) which has now created the Marketing Authorization Holder system. The new PAL requires that all medical device, IVD, and pharmaceutical companies with no location in Japan appoint a Marketing Authorization Holder (MAH).
The Market Authorization Holder must be a resident of OR maintain a place of business in Japan and employ at least three full-time employees to be licensed. If you do not have a place of business in Japan you can appoint your distributor as the MAH. The MAH does, however, maintain your device approval and registration in their name and therefore your distributor has full control over your device and commercialization.
MHLW has recognized this challenge for foreign manufacturers and included in the new PAL law an opportunity to select a Designated Marketing Authorization Holder (DMAH). Just like the MAH, the DMAH is considered fully responsible for the quality and safety of the manufacturer's products placed on the market. However, appointing a DMAH allows the foreign manufacturer to maintain control over the device and its market commercialization.
Emergo Japan K.K. is a fully registered DMAH with offices in Tokyo. As your Designated Marketing Authorization Holder (DMAH) we can:
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Ensure the marketing, quality, and safety standards of the products to be placed on the market.
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Act as the primary contact point for all Japanese authorities.
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Oversee the GQP and monitor shipping and receiving methods.
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Establish and ensure release criteria for each product
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Procure all government import licenses on behalf of the manufacturer.
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Conduct audits of your facility. (The MAH or DMAH must be able to show their audit records if requested by Japanese authorities)
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Obtain PAL certificates and other documentation for each device from the Japanese authorities and forward them to the manufacturer.
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Report manufacturing or in-process control changes.
Advantages of appointing an independent DMAH rather than a traditional MAH/Distributor:
- Selecting a D-MAH like Emergo Japan allows flexibility in the selection of distributors and allows for more control over distributors and the distribution network by the foreign manufacturer.
- If working with a MAH /Distributor and you decide to change distributors, your product(s) must be registered and approved again. This will cost you time and money to get back on the market.
- If the Japanese authorities question an incident or a non-compliance that occurred involving your device or company, will your distributor defend his company or yours?
Contact us to learn more about how Emergo Japan can become your independent DMAH - Designated Marketing Authorization Holder.
