| 1. | 通報成員：俄羅斯 |
| 2. | 負責機構：Eurasian Economic Commission Department for technical regulation and accreditation |
| 3. |
通報依據(jù)的條款：Article 2.9.2 [X], 2.10.1 [??], 5.6.2 [??], 5.7.1 [??]
通報依據(jù)的條款其他：
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| 4. | 覆蓋的產(chǎn)品：Wadding, gauze, bandages and similar products (bandaging material, adhesive plasters,poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Instruments and appliances used in medical, surgical, dental or veterinary sciences,including scintigraphic apparatus, other electro-medical apparatus and sight testing instruments (HS 9018); X-ray, alpha, beta, gamma radiation apparatus; x-ray tubes, x-ray generators, high tension generators, control panels and desks, screens, examinationor treatment tables, chairs and the like (HS 9022); Furniture; medical, surgical, dental or veterinary (e.g. operating tables, hospital beds, dentists' chairs) barbers' chairs; parts (HS 9402).
ICS：[] HS：[] |
| 5. |
通報標題：Draft amendments to the Rules for conducting studies (tests) for evaluation of biological action of medical products頁數(shù)：18 使用語言：俄語 鏈接網(wǎng)址： |
| 6. |
內(nèi)容簡述： The Draft amendments to the Rules for conducting studies (tests) for evaluation of biological action of medical products to medical devices issued for circulation in the territory of the Eurasian Economic Union and provide for the following: |
| 7. | 目的和理由：Protection of human health or safety |
| 8. | 相關文件： ?Draft amendments to the Rules for conducting studies (tests) for evaluation of biological action of medical products to medical devices: https://docs.eaeunion.org/ria/ru-ru/0104121/ria_20072020 Decision No.38 of the Council of the Eurasian Economic Commission of May 16, 2016 http://www.eurasiancommission.org/en/act/texnreg/deptexreg/LS1/Documents/Rules%20for%20Studies%20%28Tests%29%20for%20Evaluation%20of%20Biological%20Action_38.pdf |
| 9. |
擬批準日期：
To be determined 擬生效日期： To be determined |
| 10. | 意見反饋截至日期：60 days from notification |
| 11. |
文本可從以下機構得到：
Eurasian Economic Commission Department for technical regulation and accreditation http://www.eurasiancommission.org/en/act/texnreg/deptexreg/LS1/Documents/Rules%20for%20Studies%20%28Tests%29%20for%20Evaluation%20of%20Biological%20Action_38.pdf |
The Draft amendments to the Rules for conducting studies (tests) for evaluation of biological action of medical products to medical devices issued for circulation in the territory of the Eurasian Economic Union and provide for the following:
- clarification of the concepts;
- determining the grounds for excluding testing laboratories (centers) from the unified register of authorized organizations that have the right to conduct research (testing) of medical devices for the purpose of their registration;
- clarification of the form of the Protocol of studies (tests) for evaluation of biological action of medical products.
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