Ukraine | Draft Law of Ukraine "On Medical Devices" (9 page(s), in Ukrainian)

Title of document
Draft Law of Ukraine "On Medical Devices" (9 page(s), in Ukrainian)

Description
the draft Law aims at:  elimination of ambiguous interpretation of the norms regarding classification of medical devices; reduction of the circulation of counterfeit medical devices;  elimination of double proof of safety of medical devices (deregulation);  regulation of advertising of medical devices;  creation of legal grounds for the development of legal acts concerning clinical investigations and performance evaluation;  determination of the legal grounds for taking market surveillance measures for all medical devices, regardless of the method of placing on the market;  simplification of the conformity assessment procedure through the use of remote audits.

Notifying member: Ukraine

Notification: G/TBT/N/UKR/207

Objective tag
Prevention of deceptive practices and consumer protection; Protection of human health or safety

Objective
The purpose of the adoption of the Law of Ukraine "On Medical Devices" is to eliminate aspects of the circulation of medical devices that are not regulated by current legislation of Ukraine.

Agency responsible
Ministry of Health of Ukraine

Timing:

• Submission: 02/11/2021
• Reception: 02/11/2021
• Distribution: 03/11/2021
• Final date for comments: 02/01/2022
• Proposed date of adoption: N/A