Changes in Taiwan’s Medical Device Regulations

In April 2004, Taiwan’s Department of Health (DOH) published a new draft that will alter the classification and registration system for medical devices in Taiwan. The regulation will be formally announced in late 2004, once the DOH receives feedback from the medical industry.

Currently, Taiwan classifies medical devices into three classes. However, the updated regulation will add new sub-categories to the three classes, which will cause some devices to be reclassified. Currently, Class I products only require Quality System Documentation (QSD) registration with the DOH and are exempt from product registration. This will change in late 2004, when some Class I products will require product registration. Class II and III products will continue to require QSD registration, as well as product registration.

Additionally, several other draft proposals have recently been announced in Taiwan. The DOH released a draft regulation on Post Marketing Surveillance (PMS) in June 2004. Once it goes into effect, designated medical devices will be subject to the PMS regulation for three years after the product license is granted. In July 2004, the DOH released a draft regulation on the Exchange of Letter (EOL) with the Quality of Auditing Third Parties of the European Union (E.U.). The draft, which was put into effect August 2004, recognizes six parties within the E.U.: TÜV PS, TÜV Rhineland, mdc, NSAI, BSI and G-Med. Plants in the E.U. that are certified by one of these parties will have simplified QSD registration requirements (like U.S. plants that have been inspected by the FDA).