Japan Medical Device Certificate

Medical device manufacturers run into many challenges when operating in another country. One of them is the Japanese Pharmaceutical Affairs Law (PAL) and its regulations for medical device manufacturers in Japan. The Japanese Pharmaceutical Affairs Law sets the legal requirements for manufacturing and distributing medical devices and pharmaceutical products in Japan.

As a third-party certification body registered with the Japanese Minister of Health, Labour, and Welfare, we can carry out certification of your "controlled medical device" under PAL Article 23-2 and ISO 13485.

Benefits: with our Japanese PAL services, you can:

• Access the market of Japan, one of the world's largest economies.
• Achieve conformity with Good Clinical Practice (GCP) and various safety measures under the Japanese Pharmaceutical Affairs Law, Good Quality Practice (GQP), Good Vigilance Practice (GVP), and ISO 13485:2003.
• Keep documentation in line with safety standards and reduce conformity risk.
• Save significant cost and time by using a single source for all testing and conformity needs.

Our services:

• Assessment of the safety and effectiveness of the medical device
• Conformity assessment of the manufacturer's quality management system against ISO 13485 and the specific deviations of the Japanese regulations