Taiwan market access for Medical Devices
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.