Marketing Authorization Holder (D-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) and now this is referred to as a 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 sometimes goes by similar names such as Market Approval Holder, Marketing Approval Holder or Market Authorization Holder.

Requirements for the Japanese MAH

The Marketing Authorization Holder (MAH) 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. Like the MAH, the D-MAH is considered fully responsible for the quality and safety of the manufacturer's products placed on the market and therefore incurs considerable risk. However, appointing an independent MAH allows the foreign manufacturer to maintain control over the device and market commercialization. This is called the "Foreign Special Approval System" under PAL.

Emergo is an independent Japan MAH with offices in Tokyo.

Emergo Japan K.K. holds a Type 1 license from the PMDA and is authorized to act as a D-MAH for all classes of medical devices. As a Designated Marketing Authorization Holder (D-MAH) we are required to:

• Ensure the marketing, quality, and safety standards of the products to be placed on the market.
• Act as your primary contact point for all Japanese authorities.
• Assist in incident reporting.
• Oversee the GQP and monitor shipping and receiving methods.
• Communicate with your distributor(s) and create the Import Procedure. We also prepare and submit the Import Submission and clear products through Japanese Customs.
• Responsible for establishing the Quality Standard (Hinshitsu Hyojun Syo) and creating the release criteria for releasing products to the distributor.
• Communicate with your packaging manufacturer to develop the Quality Agreement and indicate to prepare Manufacturing Standard (Seihin Hyojun Sho) for labeling, and warehousing as applicable.
• 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.
• We register JAN code to MEDIS for each item of the products.

Helping you maintain full control over your devices in the Japanese market is our goal.

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