Important certificate for market access in Taiwan
Simplified access to the Taiwanese market
Faster product approval in Taiwan
Time and cost savings
Audits by authorities in Taiwan often no longer required
TCP III - Important prerequisite for market approval of medical devices in Taiwan
DQS MED is one of the few notified bodies in Europe that can provide TCP III certification and thus facilitate access to the Taiwan market for EU medical device manufacturers. The proof of a certified QM system according to ISO 13485 with a special audit report written by DQS MED, ISO 13485 certificate and a cover letter simplifies the product approval in Taiwan for our European customers, because no audit by a TFDA recognized auditing body is required anymore.
For which companies is TCP III certification important?
What requirements must be met in TCP III?
The regulatory authority in Taiwan classifies medical devices according to Class 1, 2 or 3 risks. This is based on the scheme developed by the U.S. FDA. Thus, Class 2 and 3 medical devices must first have been approved in their home market before approval can be granted in Taiwan.
How can DQS MED support your company with TCP III?
How does a Technical Cooperation Program (TCP lll) in Taiwan certification work?
In the first step, you discuss your company and the goals of TCP lll certification with us. Based on these discussions, you will receive an individual offer tailored to the needs of your company or organization.
In a pre-audit, we check which prerequisites are already in place to obtain TCP III certification. This could be, for example, a certified QMS according to ISO 13485. Based on the pre-audit, we arrange a project planning meeting with you to discuss the next steps.
The certification audit for TCP III starts with an analysis and evaluation of your system and determines whether your management system is ready for certification or compatible with the standard in Taiwan. In the next step, your on-site DQS auditor evaluates the effectiveness of the management processes using the standards. The results are presented at a final meeting and action plans are agreed upon as needed.
After the audit, the results are evaluated by the independent certification board of DQS MED. If all requirements are met, you will receive a special audit report, ISO 13485 certificate and a cover letter confirming that your QMS meets all requirements of the Taiwanese regulatory authorities.
Either semi-annually or annually, key components of the system are re-audited on-site for further improvement. The certificate expires after no more than three years, but recertification is performed before expiration to ensure continued compliance.
How much does TCP lll certification cost?
For these reasons, the costs for certification according to TCP lll cannot be given as a lump sum. However, we will be happy to provide you with an individual offer for your company, organization or authority.
Why should you have your company certified according to TCP III with DQS MED?
- Personal contacts and customer-oriented service
- Many years of experience with partners from Taiwan