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) |
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.