RUSSIA | Draft amendments to the Rules for conducting studies (tests) for evaluation of biological action of medical products

Title of document
Draft amendments to the Rules for conducting studies (tests) for evaluation of biological action of medical products (18 page(s), in Russian)

Description
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.

Notifying member: Russian Federation

Notification: G/TBT/N/RUS/104

Objective tag
Protection of human health or safety

Documents

• Rules%20for%20Studies%20%28Tests%29%20for%20Evaluation%20of%20Biological%20Action_38.pdf

Agency responsible
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

Timing:

• Submission: 11/08/2020
• Reception: 12/08/2020
• Distribution: 13/08/2020
• Final date for comments: 11/10/2020
• Proposed date of adoption: N/A