Taiwan market access for Medical Devices

Taiwan Food and Drug Administration (TFDA), Technical Cooperation Programme (TCP) and ISO 13485

Manufacturers wishing to sell their products in Taiwan must comply with registration requirements of the Taiwan Food and Drug Administration (TFDA) 

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

Update on Taiwan's Technical Cooperation Programme (TCP II)

Following the official announcement on Friday 31 January 2020 that the UK has officially ceased to be a member of the European Union, we want to clarify what the impact is for Taiwan’s Technical Cooperation Programme (TCP).

The UK has now entered a transition period in which it will negotiate future business and trade agreements with the EU. The transition period is due to end on Thursday 31 December 2020.

This means we will still be able to support our clients’ applications to Taiwan under TCP II until the coming into force of TCP III without any gaps. Both BSI UK (for UKAS certificates) and BSI NL (for RvA certificates) have applied to TFDA to be designated under TCP III in the first run.

Please contact TFDA for any further support >

The Taiwanese regulatory system

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.

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.