Marketing Authorization Holder (MAH) Representation for Japan

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 (MAH) system. The new PAL requires that all medical device, IVD, and pharmaceutical companies with no location in Japan appoint an MAH. This role is often referred to as a Market Approval Holder, Market Authorization Holder or Designated Marketing Authorization Holder.

The Marketing Authorization Holder must be based in Japan, be formally licensed by the MHLW and employ three people including a General Manager, Quality Manager and Safety Manager. Emergo Japan K.K. is a licensed independent Designated Marketing Authorization Holder.

While it is possible for overseas manufacturers to appoint a distributor as their MAH, it is unwise to do so. The MAH submits and maintains your device approval and registration in its name. Your MAH, therefore, has control over your device and commercialization. Appointing a distributor, may lead to challenges if you decide to switch or add distributors in the future.

The MHLW has recognized this challenge for foreign manufacturers and included in the new PAL an opportunity to select an independent "designated" Marketing Authorization Holder, sometimes called a D-MAH. Just like the MAH, the D-MAH is considered fully responsible for the quality and safety of the manufacturer's products placed on the market. However, appointing an independent MAH allows the foreign manufacturer to maintain control over the device and market commercialization.

Emergo Japan K.K. is a licensed, independent MAH with offices in Tokyo. As your designated Marketing Authorization Holder we are required to:

• Ensure the marketing, quality, and safety standards of the products to be placed on the market.
• Act as the primary contact point for all Japanese authorities.
• Assist in incident reporting.
  
• Oversee the GQP and monitor shipping and receiving methods.
• Establish and ensure release criteria for each product.
• Procure all government import licenses on behalf of the manufacturer.
• Conduct audits of your facility, when applicable. (The MAH must be able to show their audit records if requested by Japanese authorities).
• Obtain PAL certificates and other documentation for each device from the Japanese authorities and forward them to the manufacturer.
• Report manufacturing or in-process control changes to authorities as applicable.
  

Please contact us for more information or a free proposal on independent Marketing Authorization Holder (MAH) representation for Japan.