Taiwan Technical
Cooperation Programme (TCP lll)
Manufacturers planning to enter the Taiwanese market with their medical devices require a licence, which must be applied for by the importer in Taiwan. As part of this product authorisation, the manufacturer must also provide evidence of a quality management system (QMS) by means of comprehensive documentation in English or traditional Chinese.
The aim of the Taiwan Technical Cooperation Programme (TCP lll) is to reduce the application documents relating to the QM system for manufacturers in Europe and to avoid additional auditing by Taiwanese authorities.
mdc - certifying organisation for TCP III
We are one of the few Notified Bodies in Europe to be recognised by the Taiwan Food and Drug Administration (TFDA) in Taiwan under the Technical Cooperation Programme (TCP III).
A quality management system (QMS) certified by us in accordance with ISO 13485 in conjunction with a specially written audit report, a certificate in accordance with ISO 13485 and a cover letter simplifies product approval in Taiwan for our European customers, as the submission of extensive QM documents and an audit by a Taiwanese body are no longer required.
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TCP III - Market access in Taiwan
If a manufacturer based in the EU, Switzerland or Liechtenstein wishes to make use of the Technical Cooperation Programme (TCPIII) as part of its application for approval, it can submit a corresponding request to us in advance of the next audit.
The audit will cover all aspects of ISO 13485 as well as random samples of products supplied to Taiwan and processes affecting Taiwan (e.g. complaints and incidents). Following the audit, a special English-language audit report will be prepared with reference to TCP III. This report is submitted together with the corresponding certificate and a cover letter explaining the procedure via the local importer in Taiwan.
Assuming there are no significant changes, this audit report is routinely prepared and submitted every 3 years.
It should be noted that this report is only part of the authorisation procedure and that further extensive documents must be submitted as part of the product authorisation.
We offer those interested in this additional service the opportunity for an initial exchange of information.
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