Taiwan Technical Cooperation Program (TCP)

Taiwan's Technical Cooperation Program (TCP) allows European medical device manufacturers to significantly reduce the documentation needed to gain market approval.

Medical device manufacturers wishing to sell in Taiwan must follow a lengthy process before their products can be placed on the market. The documents required are as follows:

Section "A"

  • Quality system documents and procedures (in English and/or local Taiwanese language)
  • Floor plans of the manufacturing site
  • Process flow diagrams for each product

Section "B"

  • Technical file for each product (in English and/or local Taiwanese language)

The manufacturer must send everything in Section "A" to a Taiwanese certification body, then to the Taiwanese Department of Health. Section "B" must also go to the Taiwanese Department of Health.

Intertek is one of the few certification bodies to be recognized under Taiwan's Technical Cooperation Program (TCP). If your company is based in Europe, or has European manufacturing sites, you can replace the prolonged Section "A" with an ISO 13485 certificate and letter from Intertek.

By lending a hand with our auditing core competence, we help you go beyond basic compliance to reduce documentation and reach the Taiwanese market faster than ever before.

 

Related Links

Need help or have a question? +1 800 810 1195
 

Need help or have a question?

+1 800 810 1195
UK
+44 (0) 116 296 1620
EMEA
+46 8 750 03 33
Asia Pacific
+86 21 50273066