Accéder au marché taïwanais pour les dispositifs médicaux (page en anglais)

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.

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.

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.

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.