Japan PAL Update for Foreign Manufacturers of Medical Devices

The Japanese Ministry of Health, Labor and Welfare recently issued an update to Notification No. 0709004, released last year, which outlined the dossier requirements for obtaining a foreign manufacturer certificate. According to the 2002 Pharmaceutical Affairs Law (PAL), any foreign medical device manufacturer must apply and be approved for a foreign manufacturer certificate before it can produce goods for sale in Japan.

The original PAL included a requirement for a doctor’s letter verifying that the foreign manufacturing plant manager did not have a mental disorder and did not use illegal drugs. The updated PAL now allows the plant manager to submit a “self-declaration†attesting to the above statements if it is impossible or difficult to get a doctor’s letter. However, the plant manager would also be required to explain why the doctor’s letter could not be obtained.

The dossier file for obtaining the foreign manufacturer certificate must also include information on the plant manager’s work experience and background, detailed descriptions of the goods to be exported to Japan and their manufacturing process, a list of all manufacturing equipment to be used, and any domestic licenses held in the manufacturer’s home country. Once granted, the foreign manufacturer certification is valid for five years.