Page 59 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

(3) Promoting Good Distribution Practice (GDP) for Medical Devices
To ensure that medical device importers, dealers, or pharmacies are capable of maintaining
product quality specified by the original manufacturer during transport and sales activities,
the TFDA began implementing regulatory measures for the distribution of medical devices
starting in 2014 and promulgated the Good Distribution Practice (GDP) for Medical Devices on
June 18, 2015. As of the end of 2015, TFDA organized six training seminars and two outcome
presentation seminars, and completed consultation visits to 35 medical device vendors.
(4) Implementing the Unique Device Identi?cation (UDI) System Part II - Key Administrative Results Medical Devices Management
The three issuing agencies and their coding specifications (GS1/GS1-128, HIBBC/HIBC,
ICCBBA/ISBT 128) recommended by the International Medical Device Regulators Forum
(IMDRF) and U.S. FDA were adopted by TFDA to promulgate the Unique Device Identi?cation
(UDI) System Regulation on October 30, 2015. This would allow both importers and domestic
manufacturers to adopt globally recognized UDI coding and barcode specifications for
medical devices in establishing the basis for automated distribution management.
3. Strengthening Awareness of Medical Device Regulatory Policies
(1) Promotion of Key Policies
In 2015, TFDA organized about 30 promotional activities that included training sessions and
seminars for Good Distribution Practice (GDP) of medical devices, introduction and use of
the UDI system, medical device GCP inspection workshop and regulation revisions, medical
device clinical trial IRB forums and symposiums, medical device adverse event analysis and
management, for enforcing the implementation of various key policies.
(2) Enhancing Communication With Medical Institutions
To help medical institution personnel acquire an effective understanding of the causes for
ADRs as well as user experiences of medical devices, and to gain familiarity with proper
handling methods, procedures, and government regulatory practices, TFDA held education
and training courses at six medical institutions in northern, central, and southern Taiwan in
2015. The courses targeted non-ideal situations primarily during the process of operating
medical devices in local medical institutions, such as failure to perform, malfunction, or
anomalies of medical devices, and allowed for information exchanges and sharing of
experiences.

(3) Establishing a Communication Platform for Industry Associations
In 2015, TFDA held two communication meetings with industry associations of medical
devices. The platform allowed direct dialogue with the industry in order to achieve a mutually
bene?cial consensus over relevant policies and facilitate the promotion and implementation of
future policies.
(4) Strengthening Regulatory Knowledge and Capacity for Medical Devices amongst Academic
Research Institutions

TFDA held three seminars promoting awareness of medical device regulations in various
universities, colleges, and medical engineering institutions, with the hope that the academia
and industry may promptly apply regulatory concepts pertaining to medical devices in the
initial phases of research and development (R&D) in order to shorten R&D cycle time and
costs and to commercialize the R&D outcomes as early as possible.
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