Taiwan Announces New Documentation for Class III Medical Devices

Beginning January of 2013, the Taiwanese Food and Drug Administration (TFDA) will begin trial of the Essential Principles (EP) and Summary of Technical Documentation (STED) format for class III devices, with mandatory EP/STED required for all 2014 submissions. The move is part of a larger effort by Taiwan to adhere to international standards, set by the Global Harmonization Task Force (GHTF), like North American and European regulatory agencies.

The TFDA STED/EP dossier will require the following:

  1. Device description and product specification
  2. Essential Principle checklist
  3. Risk analysis and control summary
  4. Design and manufacturing information (device design, manufacturing process, design and manufacturing sites)
  5. Product verification and validation
  6. Labeling

Depending on the device, the TFDA may require additional documents, such as sterilization, biocompatibility, software validation, animal study, and clinical evidence, among others.