PAL: Pharmaceutical Affairs Law (Japan)

Certification services for medical devices / in-vitro diagnostic reagents under the new Japanese Pharmaceutical Affairs Law

Under the revised new Pharmaceutical Affairs Law (PAL) from April 2005, registered third party certification bodies are allowed to assess the medical devices classified as class 2 with conformity certification criteria (MHLW notice No. 112 issued on 2005-03-25). For in vitro diagnostic reagents, all classified as class 2 can be assessed by registered third parties.
Manufactures in foreign countries have to have a marketing authorization holder (MAH) in Japan.

TÜV SÜD Japan is officially registered as certification body as of April 1st, 2005 and started to accept the applications for marketing certification.