Page 78 - 2018食藥署年報(英文版)

Implementation Measures

1. The Administration started to separately plan the medical device law framework and legality

assessment in 2014 by reference to international management regulations and our own national
conditions, and invited the industrial, governmental, academic, and research representatives
to attend the negotiation meeting so as to collect opinions. By the end of 2017, 16 rounds
of workshops and discussion meetings had been held to help concerned parties understand
highlights of the draft. (See Figure 5-1 for the process of promoting the Draft Medical Devices
Act.)
2. In order to realize an open and transparent government, the draft was announced on December
5, 2016 to facilitate the collection of diversified opinions. The WTO reporting procedure was
completed on January 31, 2017. Respective member states had 60 days to provide opinions.

During the period, a total of 34 unions, associations, societies, or institutions submitted
letters expressing their opinions and all the opinions were included while the draft was under
assessment. It was reviewed and approved by the Executive Yuan on December 14, 2017. The
draft consisted of 83 articles in total.
3. The Legislative Yuan passed the first reading of the Draft Medical Devices Act on December
29, 2017, and submitted it to the Social Welfare and Environmental Hygiene Committee of the
Legislative Yuan for review.

‧ Opinions from the regulatory authori-
ty, respective ministries and depart-
ments under the Executive Yuan, local ‧February 9, 2018: Act assessment
government health authorities, and workshop at the Legal Affairs Bureau
unions and associations were collect- of the Legislative Yuan
ed to support the legitimacy of articles ‧March 1, 2018: Briefing sessions on the
included in the draft. draft were organized; a total of around
‧6 rounds of briefing meetings with 80 representatives from health author-
The draft was respective parties were organized. The legislation process ities, medical device and hospital
completed. ‧December 5, 2016: The draft was was launched. unions and associations, and the
announced to facilitate collection of Legislative Yuan took part in those
2014-2015 public opinions. 2017 sessions.
‧Separate planning of the medical 2016 ‧January 31, 2017: WTO was notified and 2018
device law framework and legality the draft was submitted to the WTO for
assessment were started. The draft was launched comments by member states to avoid Legistative procedure
‧Medical device management regu- to solicit opinions. technical trade barriers.
lations in different countries were ‧4 rounds of briefing sessions were orga-
referred to and related articles on nized for businesses concerned in the
medical devices in the Pharmaceuti- draft. A total of around 400 business
cal Affairs Act were combined to operators attended those meetings.
complete the draft. ‧June 15, 2017: The draft was submitted
‧Experts and representatives from to the Legal Affairs Committee of the
local government health authorities Ministry of Health and Welfare for
and unions and associations were review.
asked to attend the policy briefing ‧August 30, 2017: The draft was submit-
session. ted to the Executive Yuan for review.
‧6 rounds of briefing meetings with ‧December 15, 2017: The draft was sent
experts and other interested parties through an official letter to the Legisla-
were organized. tive Yuan for review.
‧December 29, 2017: The Legislature
passed the first reading of the draft.

Figure 5-1. The process of promoting the Draft Medical Devices Act
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