Doing business in another country presents many challenges – compliance with local laws can be one of the most challenging. TÜV Rheinland can help with Japan’s Pharmaceutical Affairs Law (PAL).
The intent of the PAL is to harmonize requirements and reduce some of the conflicting demands by incorporating the guidance documents of the Global Harmonization Task Force (GHTF). This includes quality management systems (QMS) requirements based on the ISO 13485:2003 norm.
TÜV Rheinland is registered with the Japanese Minister of Health, Labor, and Welfare as a third-party certification body. We can therefore perform your “control medical device” certification, according to revised PAL Article 23-2. We also perform ISO 13485 certification, as required in the revised PAL.
With Japanese PAL services from TÜV Rheinland, you can be sure of:
Delivered by knowledgeable and experienced experts, our services include:
TÜV Rheinland’s approach is as follows:
Our services cover electromedical products.
Japan’s Pharmaceutical Affairs Law (PAL) establishes regulations covering the manufacturing and distribution of medical devices and pharmaceutical products in Japan. This law was revised by the Minister of Health, Labor and Welfare and went into effect on April 1, 2005.
There are two components of the PAL regulations that are key to doing business in Japan: “Kyoka” and “Shonin”:
If you’re interested in TÜV Rheinland’s Japanese PAL services, you may also be interested in these services: