| 1. | 通報成員：巴西 |
| 2. | 負(fù)責(zé)機構(gòu)：National Institute of Metrology, Quality and Technology (INMETRO) |
| 3. |
通報依據(jù)的條款：Technical Regulation (Article 2.9.2)
通報依據(jù)的條款其他：
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| 4. | 覆蓋的產(chǎn)品：HS Codes: 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)
ICS：[] HS：[] |
| 5. |
通報標(biāo)題：Draft resolution number 730, 14 October 2019.頁數(shù)：18 使用語言：Portuguese 鏈接網(wǎng)址： |
| 6. |
內(nèi)容簡述： 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. | 相關(guān)文件： Resolution – RDC number 185, October 22nd, 2001 |
| 9. |
擬批準(zhǔn)日期：
To be determined after the end of the consultation period. 擬生效日期： 60 days after the date of its publication. |
| 10. | 意見反饋截至日期：30/12/2019 |
| 11. |
文本可從以下機構(gòu)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.
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