Taiwan market access

Taiwan Food and Drug Administration of the Department of Health (TFDA) and ISO 13485

Taiwan market accessManufacturers wishing to sell their products in Taiwan must comply with registration requirements of the Taiwan Food and Drug Administration of the Department of Health (TFDA), Republic of China (R.O.C). 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 Practise (GMP) requirements by submitting Quality System Documentation (QSD) prior to registration for many devices.

The Taiwanese regulatory system

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.

We have many years of experience supporting clients’ medical device registration requirements in Asia and we can assist you in properly classifying your device and submitting all necessary application documents so that you can register your device with the TFDA and begin marketing your product in Taiwan.

How can BSI help you achieve compliance with TFDA?

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 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.

Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies which include: