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 doctorâ€™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 â€œself-declarationâ€ attesting to the above statements if it is impossible or difficult to get a doctorâ€™s letter. However, the plant manager would also be required to explain why the doctorâ€™s letter could not be obtained.
The dossier file for obtaining the foreign manufacturer certificate must also include information on the plant managerâ€™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 manufacturerâ€™s home country. Once granted, the foreign manufacturer certification is valid for five years.