Important certificate for market access in Taiwan

If you plan to enter the Taiwanese market with your medical devices, you need an approval. DQS Medizinprodukte (DQS MED) is recognized according to the Technical Cooperation Programme (TCP III). With your quality management certified by DQS MED, it is easier and faster to obtain product approval 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

Beschreibung Standard/Regelwerk
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TCP III - Important prerequisite for market approval of medical devices in Taiwan

The Technical Cooperation Programme (TCP III) gives EU-based companies the opportunity to sell medical devices on the Taiwanese market without the need for an additional audit by a TFDA-recognized auditing body.

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.

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Zielgruppe
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For which companies is TCP III certification important?

Medical device manufacturers who want to sell their products in Taiwan must meet the requirements of the Taiwan Food and Drug Administration (TFDA). TCP III certification is appropriate for European medical device companies seeking product approval in Taiwan.

Anforderungen
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What requirements must be met in TCP III?

Manufacturers from abroad (or the EU) have to prove that they follow a Good Manufacturing Practice (GMP). For this purpose, a Quality System Documentation (QSD) must be submitted. Since the Taiwanese GMP guidelines are harmonized with ISO 13485, European or foreign manufacturers can use the program as part of the QSD submission to demonstrate compliance with Taiwanese requirements.

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.

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Wie funktioniert
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How can DQS MED support your company with TCP III?

As one of the few Notified Bodies in Europe, DQS MED can audit your medical devices according to TCP III and thus facilitate your market access in Taiwan.

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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 gap assessment, 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 gap assessment, 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.

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How much does TCP lll certification cost?

How much TCP lll certification costs depends on a number of factors. For example, whether a certified management system has already been implemented plays an important role. In addition, the size of your company as well as the complexity of your quality management system have an influence on the audit duration and price.

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.

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Why should you have your company certified according to TCP III with DQS MED?

  • All important audits in the medical sector from one source
  • One of the few certification bodies for TCP III
  • Personal contacts and customer-oriented service
  • Many years of experience with partners from Taiwan
  • Personal contacts and customer-oriented service
  • Many years of experience with partners from Taiwan
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"We will be happy to provide you with a customized quote for TCP III certification."