Russia | Draft amendments to the Rules for registration and examination of safety, quality and effectiveness of medical devices

Title of document
Draft amendments to the Rules for registration and examination of safety, quality and effectiveness of medical devices (104 page(s), in Russian)

Description
The Draft amendments to the Rules for registration and examination of safety, quality and effectiveness of medical devices apply to medical devices issued for circulation in the territory of the Eurasian economic union and provide for the following: - clarification of terms and definitions; - clarification of the mechanism for implementing the procedure for approval by States of the recognition of the expert opinion of the reference state; - determination of cases when changes are made to the registration dossier of medical devices in the notification procedure; - clarification of the procedure for canceling the validity (cancellation) of the registration certificate of a medical device.

Notifying member: Russian Federation

Notification: G/TBT/N/RUS/99

Objective tag
Protection of human health or safety

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: 20/02/2020
• Reception: 20/02/2020
• Distribution: 21/02/2020
• Final date for comments: 20/04/2020
• Proposed date of adoption: N/A