Taiwan Technical Cooperation Program (TCP)

Medical device manufacturers wishing to sell in Taiwan without using the services of a selected EU certification body are currently required to 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.

The Technical Cooperation Program (TCP), through a letter of understanding between Taiwan and selected EU certification bodies (including Intertek), allows the lengthy Section "A" to be replaced by a current ISO 13485 certificate and a letter supplied by Intertek.

This scheme is limited to European manufacturers or European manufacturing sites.

What the client must do for the TCP

• Appoint a Taiwan-based representative
• Contact Intertek to perform an audit to ISO 13485 and issue the certificate
• Contact Intertek to advise of requirements for Taiwanese approval:
  • Submit Technical File(s) for intended product(s) for the Taiwanese market
  • A copy of the ISO 13485:2003 certificate
  • A copy of the last audit report
  • A letter supplied from Intertek to the Taiwanese Department of Health

To learn more about the TCP

For further information, please contact Ron Nash of our UK office at +44 (0) 1908 857746