Gain market access in Taiwan with TFDA approval

The UK has officially ceased to be a member of the European Union and we want to clarify what the impact is for Taiwan’s Technical Cooperation Programme (TCP). We are still be able to support our clients’ applications to Taiwan under TCP II until the coming into force of TCP III without any gaps. BSI NL (for RvA certificates) has been designated to TFDA under TCP III.

Pre-market approval is necessary for all classes of medical devices prior to Taiwanese market entry.

Foreign manufacturers must demonstrate their compliance with Good Manufacturing Practice (GMP) requirements by submitting Quality System Documentation (QSD) prior to registration for many devices.

The Taiwanese regulatory system classifies devices as Class I, II or III depending on risk. This system is based on the US FDA medical device classification scheme. Class II and III devices must have home country approval in place prior to Taiwanese registration.

Class I sterile, Class I measuring, Class II and Class III medical devices must comply with GMP requirements before product licenses are granted by the TFDA. TFDA Authorized Auditing Organizations perform on-site inspection for local manufacturers in accordance with GMP and also review Quality System Documentation (QSD) provided by foreign manufacturers.

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.