New Labeling Requirements for Medical Devices in Japan

Following the implementation of the New Pharmaceutical Affairs Law (PAL) in Japan on April 1, 2005, foreign companies registering and marketing their products in Japan should be aware of the new regulatory changes that have taken place. These changes include the new requirement to appoint a Marketing Authorization Holder (MAH), new GMP requirements and changes in the classification and labeling of medical devices.

Under the new PAL, the Ministry of Health, Labor and Welfare (MHLW) requires new information be listed on the product insert of all medical devices. First, the classification of the medical device must now be listed. Second, the address of the MAH needs to be included. Prior to April 1, the contact information listed on the packaging could be the company headquarters; under the new PAL, the contact information must be the location where the marketing of the product is handled. In addition to the MAH contact information, all devices manufactured overseas should provide the location of the manufacturing site as well. The MHLW highly recommends that companies should complete the revisions of their product labels by March 31, 2006.

Beginning June 1, 2005, the Pharmaceutical and Medical Device Agency (PMDA) website started to disclose to the public medical device package inserts of products currently on the market in Japan. Listing on this website is optional for companies (but recommended by the PMDA) and requires setting up an account with the PMDA.