Because of the growing living standard and increasing awareness of health issues, the Taiwanese are spending more on healthcare. The medical device market takes profit of this prosperity. Most of the local demand for advanced equipment is imported. As a result, opportunities for 
foreign suppliers of advanced
medical devices are good.

As part of the Pharmaceutical Affairs Act, the Medical Device Regulation and Medical Device Licence Review Regulation came into effect in December 2004. Premarket registration and reviewing of medical devices is required. An ISO 13485 equivalent certificate of an independent auditing organization authorized by the government of the exporting country is obligatory. 

KEMA is in the process with three testing houses in Taiwan and individual Notified Bodies in Europe to recognize each other’s certificates. When this so called Technical Cooperation Programme is formally started, KEMA can give you the one-stop shopping opportunity to gain access to the Taiwanese market. ‘For our European customers it means they will be able to skip one of the two approval phases’, says Gert Bos, ‘The currently obliged quality system requires answering in-depth questions, following detailed procedures and making extensive translations in English. When we are accreditated, this obligation disappears. So manufacturers can save a lot of money and time coming to us.’