Uzbekistan - MedStandard

Uzbekistan

State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment of the Agency for Development of Pharmaceutical Industry of the Ministry of Health of Uzbekistan

No.415-I dated April 25, 1997 “On Medicines and Pharmaceutical Activities”

 

No.213 dated March 23, 2018 “On Approval of the Regulations on the Procedure for State Registration of Medicines, Medical Devices and Medical Equipment and Issuance of Registration Certificates”

5 years

Uzbek, Russian

4–6 months

not required

A brief algorithm for registration of medical devices in Uzbekistan:

01

Collection of registration dossier

02

Approval of the Application

03

Drawing up the dossier, obtaining medical device samples and submission to the Regulatory Authority

04

Initial examination (availability of documents according to the approved list)

05

Receipt of the contract and invoice for the expertise, payment initiation

06

Examination of the registration dossier by the New Medical Technology Committee

07

Carrying out laboratory tests

08

Receipt of the registration certificate table (template) and further approval

09

Entering medical device into the State Register

10

Issuance of registration certificate

Final price and terms procedures will be calculated according to your request