Major Changes set for Taiwan's Medical Device Registration Process

Friday, April 17, 2015

Source: Mass Device

The Taiwan Food and Drug Administration (TFDA) plans to implement significant changes to its registration and approval system for medical devices, according to Emergo consultants in Taipei.

The regulatory changes will take effect starting July 1, 2015.

First, TFDA will introduce a two-step review program for marketing authorization applicants. The first step of the new process will entail review of administrative documents within 10 days of submission. These documents will have to include:

  • Application forms
  • Quality System Documentation (QSD) approval letters
  • Authorization letters
  • Certificates to Foreign Governments (CFG) or Certificates of Free Sale (CFS)

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