G/TBT/N/RUS/104-广东省农食产品技术性贸易措施(WTO/SPS)信息平台

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世界贸易组织

G/TBT/N/RUS/104
2020-08-12

技术性贸易壁垒

通报

以下通报根据TBT协定第10.6条分发

1.	通报成员：俄罗斯
2.	负责机构：Eurasian Economic Commission Department for technical regulation and accreditation
3.	通报依据的条款：Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ] 通报依据的条款其他：
4.	覆盖的产品：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.	通报标题： Draft amendments to the Rules for conducting studies (tests) for evaluation of biological action of medical products 页数：18 使用语言：俄语链接网址：
6.	内容简述： 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: - 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.
7.	目的和理由：Protection of human health or safety
8.	相关文件： 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.	拟批准日期： To be determined 拟生效日期： To be determined
10.	意见反馈截至日期：60 days from notification
11.	文本可从以下机构得到： Eurasian Economic Commission Department for technical regulation and accreditation Tel: +7(495)669-24-00 Fax: +7(495)669-24-15 E-mail: dept_techregulation@eecommission.org Web-site: www.eurasiancommission.org, https://docs.eaeunion.org/ru-ru http://www.eurasiancommission.org/en/act/texnreg/deptexreg/LS1/Documents/Rules%20for%20Studies%20%28Tests%29%20for%20Evaluation%20of%20Biological%20Action_38.pdf https://docs.eaeunion.org/ria/ru-ru/0104121/ria_20072020

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.

附件：

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通报原文：