In July 2002, the Japanese House of Representatives passed the amended Pharmaceutical Affairs Law (PAL), which is applicable to all the medical devices, drugs, quasi-drugs and cosmetics entering the Japan market. The amended PAL will go into effect on April 1, 2005, serving the purposes of:
- Enhancing the safety measures of medical devices being sold in the Japan's market.
- Strengthening the post-marketing safety measures of medical devices.
- Fortifying medical devices' review system for approval and license while taking international conformity into account.
PAL Before Revisions
Under the current PAL, it is assumed that the legal license holders of any medical devices have their own manufacturing facilities. For each item of product, the legal license holder has to apply for a license to be a recognized manufacturer and an approval of the medical device he manufactures. The license and approval system under the existing PAL is said to have the following inadequacies:
- Post-marketing safety measures for controlling medicaldevices are insufficient.
- Owing to the differences in certification systems, the market practices of Japan are not aligned with those in the United States and Europe.