Taiwan market access for Medical Devices

BSI and the Taiwan Technical Cooperation Programme-III

BSI and the Taiwan Technical Cooperation Programme-III

BSI Group is a TFDA-recognised (MDR/IVDR) Notified Body partner in the Technical Cooperation Programme-III (TCP-III).

Under conditions, TCP-III enables QMS audit reports and QMS certificates to be exchanged between TFDA-recognised Notified Body partners and TFDA-Authorised Auditing Organisations (AAOs).

These documents can support product applications by manufacturers based in the EU, Switzerland, or Lichtenstein, and support EN ISO 13485 applications by manufacturers based in Taiwan.

Announcement

As of 02 September 2022, BSI (NB 2797) is recognised by Taiwan Food and Drug Administration (TFDA) as a Notified Body partner in TCP-III. EU-based clients holding an RvA accredited EN ISO 13485 certificate can now contact BSI to apply for the Taiwan TCP-III scheme. Taiwan-based manufacturers seeking an EN ISO 13485 certificate can now contact BSI to apply for certification supported by a QMS audit report issued by an AAO.

What is the Technical Cooperation Programme-III (TCP-III)

The objective of the Technical Cooperation Programme is to reduce the potential duplication of auditing efforts of EU manufacturers by TFDA-AAOs and Taiwan manufacturers by Notified Bodies resulting in reduced costs for manufacturers and may boost speed to market.

What is BSI's role in market access in Taiwan?

BSI is a partner in The Technical Cooperation Programme (TCP) on exchange of medical device GMP and ISO 13485 Audit Reports between EU AIMD/MDD/IVDD Notified Body Partners and TFDA Authorized Medical Device GMP Auditing Organizations.

Medical device manufacturers with manufacturing facility located in the EU may utilize the TCP by providing a BSI ISO 13485 certificate and audit report to TFDA Authorized Auditing Organizations. The audit report from us replaces the requirement to submit QMS documentation for the purpose of product registration in Taiwan which significantly reduces the time and cost in demonstrating compliance with requirements.

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