The Japanese PAL Certificate: medical-device manufacturers operating outside Japan face many challenges. One of them is this certificate, prepared under Japan's Pharmaceutical Affairs Law for organizations that manufacture medical devices to be used in Japan.

Manufacturers based outside Japan must first hold a marketing authorization license to sell pharmaceutical devices manufactured in other countries into Japan.

Japan's Pharmaceutical Affairs Law sets out the amendments covering the manufacture and distribution of medical and pharmaceutical products in Japan. The law was reviewed by the Ministry of Health, Labour and Welfare and came into force on 1 April 2005.

To sell your manufactured medical devices within Japan, you must comply with Japanese medical-device regulations known as JPAL (Japan Pharmaceutical Affairs Law). As more device types come under JPAL scope, certification is needed through a JPAL-registered certification body, and Sistem Patent Kalite is one such body.

Sistem Patent Kalite, as a JPAL-registered certification body, offers JPAL certification and audit consultancy services through our local offices in Japan and around the world. Our certification and testing consultancy services are delivered in your own language through our global network of offices.

Sistem Patent Kalite provides a range of consultancy services on the Japanese PAL Certificate. For more detailed information, our experienced managers and staff are always available to you.