Pacific Bridge Medical (PBM) is now licensed to act as third-party local representation under the Marketing Authorization Holder (MAH) system in Japan and as a Legal Agent in China.

The MAH system is significantly stricter than the previous In-Country Caretaker (ICC) system. Only local entities in Japan qualified as MAHs may import and sell medical products in the Japanese market. In order to qualify as an MAH, an entity must be equipped to handle quality assurance and post-marketing safety management for its imported medical product s. A MAH may be a foreign firm's distributor, its own local Japanese branch or subsidiary, or an independent third party contracted to fill the role. This latter position is referred to as a Designated Marketing Authorization Holder, or D-MAH, which PBM is qualified to act as.

PBM is also qualified to act as a Legal Agent in China. When marketing a drug or medical device in China, even if it is through a Chinese distributor, it may be important to have an independent in‐country representative that is a le gal entity registered in China. This representative serves as the required local entity that deals with the government regarding product registration and renewal, adverse event reporting, etc. Using an independent third party allows for confidentiality of technical information and means less reliance on a distributor.

A leading consulting company specializing in business expansion for medical companies in Asia, PBM was founded in 1988 by Ames Gross. Since then, PBM has worked with over 200 business entities to develop their success in the Asian markets. With a focus on assisting medical device and ph armaceutical drug companies, PBM’s services include : business development assistance such as distributor search and assistance with mergers, acquisitions and licensing, as well as regulatory assistance such as product registration, reimbursement and local representation.

PBM has offices in Shanghai, Tokyo and New Delhi, and partners in Hong Kong, Singapore, Vietnam, Indonesia, Taiwan, Thailand, the Philippines, Malaysia and Korea. With over 20 years of experience, PBM is dedicated to dev eloping strategic solutions for businesses in Asia.