广东省应对技术性贸易壁垒信息平台
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世界贸易组织
G/TBT/N/BRA/928
2019-10-29
技术性贸易壁垒
通  报
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以下通报根据TBT协定第10.6条分发
1. 通报成员:巴西
2. 负责机构:National Institute of Metrology, Quality and Technology (INMETRO)
3. 通报依据的条款:Technical Regulation (Article 2.9.2)
通报依据的条款其他:
4. 覆盖的产品:HS Codes: 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)
ICS:[]      HS:[]
5. 通报标题:

Draft resolution number 730, 14 October 2019.



页数:18    使用语言:Portuguese
链接网址:
6. 内容简述:

This draft resolution proposes the updating of the Resolution – RDC number 185, 22 October 2001, which establishes the risk classification, market authorization and technical requirements for labelling and usage instructions of medical devices.


7. 目的和理由:Protection of human health or safety
8. 相关文件: Resolution – RDC number 185, October 22nd, 2001
9. 拟批准日期: To be determined after the end of the consultation period.
拟生效日期: 60 days after the date of its publication.
10. 意见反馈截至日期:30/12/2019
11.
文本可从以下机构得到:

Brazilian Health Regulatory Agency (Anvisa)
SIA, Trecho 5, Área Especial 57
Brasília – DF/Brazil
CEP: 71.205-050
Phone.: +(55) 61 3462.5402
Website:
www.anvisa.gov.br


1
Draft resolution number 730, 14 October 2019.

This draft resolution proposes the updating of the Resolution – RDC number 185, 22 October 2001, which establishes the risk classification, market authorization and technical requirements for labelling and usage instructions of medical devices.



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