Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
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:
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.
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