UZ(MOH) - Wiselink Group-A More Controllable, Stable, and Future-Oriented Material Direction

Uzbekistan's Medical Device Regulatory Authority

The regulatory authority in Uzbekistan is the Center for Pharmaceutical Products Safety, a state agency under the Ministry of Health (MOH) of the Republic of Uzbekistan. This agency is responsible for the market authorization and regulation of medical devices within Uzbekistan, including the development and implementation of medical device regulations, standards, and guidelines; the approval of medical device registration applications; and the supervision of post-market distribution and use.

Link to the regulatory authority’s official website:https://www.uzpharm-control.uz/en/

Database link: https://www.uzpharm-control.uz/en/registries/certified-medicines

Regulatory Requirements

О лекарственных средствах и фармацевтической деятельности

(the “Law on Medicines and Pharmaceutical Activities”) and Related Amendments.

Risk Level Classification

The Center for Drug Safety uses the same risk-based classification model as EU countries to categorize medical devices into the following classes: Class I, Class IIa, Class IIb, and Class III:

Basis for Registration

ISO 13485 Certificate

Uzbekistan recognizes the registration approvals of the following countries:

①Australia

②Belgium

③United Kingdom of Great Britain and Northern Ireland

④Germany

⑤Denmark

⑥Israel

⑦Ireland

⑧Spain

⑨Italy

⑩Canada

⑪South Korea

⑫Kingdom of the Netherlands

⑬Kingdom of Norway

⑭Slovenia

⑮United States of America

⑯Finland

⑰France

⑱Swiss Confederation

⑲Kingdom of Sweden

⑳Japan

Registration Language

English.

Instructions and labels must be in Uzbek, the official language of Uzbekistan, or in Russian.

License holders in Uzbekistan

In accordance with Uzbek regulatory requirements, the applicant is the certificate holder.

The applicant refers to a commercial entity or legal entity (or an authorized representative acting on its behalf) that applies to the regulatory authorities of Uzbekistan for medical device registration and obtains a certificate.

Registration Process, Timeline, and Official Fees

Registration Process

Registration Period

Registration Fees

Official fees will be determined by the Uzbekistan Medical Device Regulatory Authority after it has assessed the risk class of the device in question.

Chapter 4 FAQ

Q: How long does it take to register a medical device product in Uzbekistan?

A: Registration in Uzbekistan can choose two approaches which are product registration and registration approval:

Registration of the product registration approach takes 7-9 months and requires the submission of CTD dossiers, samples and reference standards for laboratory tests;
The registration approach means obtaining registration certificates from the European Union, Japan and other countries recognized by Uzbekistan, and the cycle is about 1-3 months.

Q: Does it require a QMS certificate for registration of medical devices in Uzbekistan?

A: Yes

Q: Can medical device products be changed after registration?

A: Within the validity period of the certificate, the applicant submits an application for change. The application must be modified using the relevant documents. The audit period of the application and registration materials is 60-90 working days, and the time required for the applicant to respond is not included in the total evaluation period.

Q: How long is the medical device registration certificate valid in Uzbekistan?

A: 5 years.

Fill Form

Whether you need more information or wish to cooperate with us, we will guide you through every step of the regulatory process. Subscribe to our newsletter for the latest global regulatory updates.