Republic of Belarus
- Regulatory Authority:
Republican Unitary Enterprise “Center for Expertise and Testing in Healthcare”
- Language of labeling and documentation:
Belarusian, Russian
- Registration period:
5–9 months
Standard procedure
3–4 months
Simplified procedure
- Legislations:
Resolution of the Council of Ministers of the Republic of Belarus dated 02 August 2008, No.1269 “On Approval of the Regulation on State Registration (Re-registration) of Medical Devices and Medical Equipment”
Resolution of the Ministry of Health of the Republic of Belarus dated 23 April 2015, No.55 “On a set of preliminary technical works preceding the state registration of medical devices” (in edition of August 23, 2023, No.120)
- Authorized Representative:
country resident
- Certificate validity period:
indefinitely
The process of medical device regulation in the Republic of Belarus:
05
Sanitary-hygienic and technical expertise with provision of samples and receipt of the Certificate of expertise
08
Specialized examination of the registration dossier by specialists of the Ministry of Health of the Republic of Belarus with issuance of the Conclusion on compliance of medical devices with quality, safety and efficiency requirements
09
Session of the committee on medical devices of the Ministry of Health of the Republic of Belarus with the decision on state registration of medical devices and issuance of the Notification Letter
10