通报号: G/TBT/N/TPKM/372 ICS号: 11.040 发布日期: 2019-03-26 截至日期: 2019-05-25 通报成员: 台澎金马单独关税区 目标和理由: 保护消费者;防止欺诈行为
内容概述: 鉴于医疗设备涉及的科学领域广泛，医疗设备的品种、项目和部件因技术创新而复杂化，卫生福利部提出修订医疗设备管理法规第3条附录I，以澄清分类说明和预期使用情况，并与国际监管趋势保持一致。考虑到过渡期对于制造商遵守新要求是必要的，还提出了对法规第8条的修订。
正文:
世界贸易组织
G/TBT/N/TPKM/372 2019-03-26 19-1884
技术性贸易壁垒
原文：英语
通 报
以下通报根据TBT协定第10.6条分发
1.
通报成员: 台澎金马单独关税区 如可能，列出涉及的地方政府名称 ( 3.2条和7.2 条)：
2.
负责机构：卫生福利部食品药物管理署（FDA）
3.
通报依据条款： [X] 2.9.2 [ ] 2.10.1 [ ] 5.6.2 [ ] 5.7.1 通报依据的条款其他：
4.
覆盖的产品： 医疗设备; 医疗设备（ICS 11.040）。 HS编码：9018 ICS编码：11.040
5.
通报标题： 医疗设备管理法规第3条附录I和第8条修订草案
语言：英语/汉语 页数：10/7 链接网址：
6.
内容简述： 鉴于医疗设备涉及的科学领域广泛，医疗设备的品种、项目和部件因技术创新而复杂化，卫生福利部提出修订医疗设备管理法规第3条附录I，以澄清分类说明和预期使用情况，并与国际监管趋势保持一致。考虑到过渡期对于制造商遵守新要求是必要的，还提出了对法规第8条的修订。
7.
目标与理由：防止欺诈行为和消费者保护;协调。
8.
相关文件： 药事法。
9.
拟批准日期：待定 拟生效日期：待定
10.
意见反馈截止日期： 通报之后60天
11.
文本可从以下机构得到： [ ] 国家通报机构 [ ] 国家咨询点，或其他机构的联系地址、传真及电子邮件地址(如能提供):
正文(英):
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6
1.
Notifying Member: The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu
If applicable, name of local government involved (Article 3.2 and 7.2):
2.
Agency responsible:
Food and Drug Administration
Ministry of Health and Welfare
No.161-2, Kuntang St,
Nangang District, Taipei City 115-61, Taiwan
Tel.: (886-2) 2787-7524
Fax: (886-2) 3322-9492
Email: Kenneth@fda.gov.tw
Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:
3.
Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:
4.
Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Medical Devices; Medical equipment (ICS 11.040)
5.
Title, number of pages and language(s) of the notified document: Draft Amendment of Annex I to Article 3 and Article 8 of the "Regulations for Governing the Management of Medical Device" (10 page(s), in English; 7 page(s), in Chinese)
6.
Description of content: In view of the wide range of scientific fields involved in medical equipment and the complication of medical devices in terms of their varieties, items and components resulted from innovation of technology, the Ministry of Health and Welfare is proposing amendment to Annex I to Article 3 of the "Regulations for Governing the Management of Medical Device" in order to clarify the classification description and intended use situations as well as to harmonize with international regulatory trends. Considering a transition period is necessary for manufacturers to comply with the new requirements, amendment to Article 8 of the Regulation is also proposed.
7.
Objective and rationale, including the nature of urgent problems where applicable: Prevention of deceptive practices and consumer protection; Harmonization
8.
Relevant documents:
· The Pharmaceutical Affairs Act
9.
Proposed date of adoption: To be determined
Proposed date of entry into force: To be determined
10.
Final date for comments: 60 days from notification
11.
Texts available from: National enquiry point [X] or address, telephone and fax numbers and email and website addresses, if available, of other body:
WTO/TBT Enquiry Point
Bureau of Standards, Metrology and Inspection
Ministry of Economic Affairs
No.4, Section 1 Jinan Road,
Zhongzheng District,Taipei City 100, Taiwan
Tel.: (886-2) 2343-1801
Fax: (886-2) 2343-1804
E-mail: tbtenq@bsmi.gov.tw
https://members.wto.org/crnattachments/2019/TBT/TPKM/19_1753_00_e.pdf
https://members.wto.org/crnattachments/2019/TBT/TPKM/19_1753_00_x.pdf
