Taiwan Moving towards STED format for Medical Device Technical Document Submission

On May 1, 2012, the Taiwan FDA (TFDA) announced its plan to move towards Summary Technical Documentation (STED). This move is to align with GHTF SG1-N11:2008, Summary of Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices. The Global Harmonization Task Force (GHTF) encourages medical device manufacturers to follow the STED in order to achieve uniformity between different countries’ regulatory bodies.

STED will be implemented in the following stages:

  1. Experimental Stage 1 (July – Dec 2012) for Class III medical devices
  2. Experimental Stage 2 (Jan – June 2013) for Class II and III medical devices
  3. Implementation Stage 3, effective July 2013, for all Class II and III medical devices

Foreign medical device companies are suggested to include the following:

  1. Device Description and Product Specification, including Variants, Components and Accessories
  2. Essential Principles (EP) Checklist includes:
    1. Risk Analysis and Control Summary
    2. Design and Manufacturing Process
    3. Product Verification and Validation
    4. For Class III medical devices, complete test reports per STED should be provided