Japan to require ISO 13485:2003 Certification by 1 APR 2005

The revised Pharmaceutical Affairs Law (PAL) of Japan was issued today and will go into effect 1 April 2005. The revisions change the manner in which medical devices are regulated and marketed in Japan, by requiring manufacturers/exporters to obtain ISO 13485:2003 certification as part of the product licensing process. 

In addition, according to the new law, each exporting manufacturer must appoint a Marketing Authorisation Holder (MAH) - similar to the "in-country caretaker" according to the previous PAL - to be legally responsible for the manufacturers' products, quality system, and vigilance system - and must be located within the country.  Both the MAH and an inspection agency of the Japan Ministry of Health, Labor and Welfare (MHLW) may be required to inspect each manufacturer exporter in addition to imposing the ISO 13485:2003 certification requirement.

There are several concerns associated with the new law.  These include:

- Not enough MHLW accredited ISO 13485:2003 registrars available to manufacturers
- Not enough MAH organisations able to meet the requirements and charging excessive fees
- Many ISO 13485:1996 certified manufacturers have plans in place to achieve certification to the
   revised standard by July 2006.

Related to the revised PAL, requirements for MAH establishments were recently released by the Tokyo Metropolitan Government.  The CRO Group is keeping its clients updated of developments in Japan related to the PAL revision, such as to assist medical device companies in completing the MAH related process, evaluating and selecting accredited registrars, and accelerating the ISO 13485:2003 certification process..