Gain market access in Taiwan with TFDA approval

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.

Benefit to manufacturers in the EU, Switzerland, and Lichtenstein

TCP-III enables manufacturers in the EU, Switzerland, or Lichtenstein to use an abbreviated submission route under certain conditions when applying for product registration in Taiwan.

Manufacturers must have completed a QMS audit covering the requirements of EN ISO 13485 and all applicable R.O.C. QMS requirements.

A client that is signed up to the TCP-III scheme with BSI can provide documentation from BSI NL to an AAO as part of their application for product registration:

  • QMS audit report covering EN ISO 13485 and all applicable R.O.C. QMS requirements,
  • RvA accredited EN ISO 13485 certificate,
  • Regulatory Letter issued by BSI as a TFDA-recognised NB partner confirming the requirements of TCP-III are met.

This reduces duplication in the audit of certain elements of the Quality System Documentation (QSD) by an AAO.  Audit of the QSD is only part of the overall product license application in Taiwan and additional registration requirements still apply.

Benefit to manufacturers in Taiwan

Under TCP-III, Manufacturers in Taiwan applying to BSI for EN ISO 13485 certification can submit their QMS audit report (issued by an AAO) to BSI which may result in reduced EN ISO 13485 audit durations under certain conditions.