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2015 Annual Report


Risk Assessment

Management and

Research Outcomes





Laboratory and

Testing Network

Risk Communication

and Consumer



Cooperation and

Cross-Strait Exchange






Policy and








(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

in vitro

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

economic benefits.