2015 Annual Report
(2) Strengthening Post-market Management of Class 1 Medical Devices
Pharmaceutical firms have many times incorrectly declared the identification scope in the affidavit
for Class 1 medical devices. In order to safeguard medical device usage safety among consumers,
the re-evaluation mechanism for Class 1 medical devices were initiated. A total of 84 permit re-
evaluations were completed in 2014.
(3) Promoting Good Distribution Practice for Medical Devices
To ensure that medical device importers, dealers, and pharmacies are capable of maintaining
product quality specified by the original manufacturer during transport and sales, TFDA
announced the draft of Good Distribution Practice (GDP) for Medical Devices in December 2013.
Subsequently in 2014, a reward program was established to commend those who have voluntarily
implemented the GDP mechanism. TFDA organized three seminars and training sessions as well
as one achievement and commendation meeting. TFDA also visited a total of 10 medical device
vendors and provided GDP counseling to them.
3. Strengthening Awareness of Medical Device Regulations and Technologies
(1) Promoting Key Regulations and Technologies
To facilitate the promotion and implementation of key regulations, TFDA implemented a total of
25 promotional activities in 2014, including Essential Principles (EP) and Summary of Technical
Documentation (STED) of medical device safety and performance to harmonize with global trends,
drafting registration and technical guidances for
diagnostic devices (IVD), holding academic
conferences on international regulatory requirements for nano-medical devices, conducting safety
and risk assessment education and awareness seminars on the application of nanotechnology in
medical devices, implementing Good Submission Practice (GSP) for medical devices, and other key
(2) Strengthening Communication with Industry and Medical Institutions
To improve relevant personnel's competence in purchasing, acceptance verification, maintenance,
and adequate perception of medical device ADR or defective product reporting system, TFDA held
four seminars in 2014 on the appropriate selection and purchasing of medical devices in four city-level
medical institutions in Taipei, Taichung, Tainan and Hualien.
(3) Establishing a Communication Platform for Industry Associations
In 2014, TFDA held two meetings for promoting communication with medical device industry
associations. Through such platform, direct dialogue exchanges were carried out with the industry
in order to achieve a mutually beneficial consensus over policies and facilitate the development and
implementation of policies.
(4) Strengthening the Knowledge Capacity of Medical Device Regulations for Academic and Research
In order to ensure seamless integration of results from academic research institutions with industrial
development and to reduce the gap between the academic field and actual needs of industry,
TFDA has held three regulatory awareness seminars in medical engineering related conferences.
The purpose of the seminars was to encourage academic research institutions to incorporate
regulatory concepts related to medical devices during the early phases of research and development
(R&D), reduce R&D time and cost, encourage commercialization of research results, and generate