Chapter 1 Uzbek MOH Administration Information Abstract

1. Administration and Abstract

The administration in Uzbekistan is the Center for Pharmaceutical Products Safety, a subordinate state agency of the Ministry of Health of the Republic of Uzbekistan (MOH). The agency is responsible for medical device access and regulatory affairs in Uzbekistan, including the development and implementation of medical device regulations, standards and guidelines, approval of medical device registration applications, and supervision of post-market circulation and use.

2. Administrative Regulation

О лекарственных средствах и фармацевтической деятельности 

3. Risk Level Classification

The Centre for Pharmaceutical Products Safety uses the same risk-based classification model as the EU countries to classify medical devices into the following categories: Class I, Class IIa, Class IIb and Class III:

4. Registration Basis

ISO 13485 certificate

Uzbekistan recognizes the approval of registration in the following countries:

①Australian Union

②Kingdom of Belgium

③United Kingdom of Great Britain and Northern Ireland

④Germany

⑤Kingdom of Denmark

⑥Israel

⑦Ireland

⑧Kingdom of Spain

⑨Italy

⑩Canada

⑪South Korea

⑫Kingdom of the Netherlands

⑬Kingdom of Norway

⑭Slovenia

⑮United States of America

⑯Finland

⑰France

⑱Swiss Confederation

⑲The Kingdom of Sweden

⑳Japan

5. Registration Language

English.

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

6. Uzbek License Holder

According to the regulations of Uzbekistan, the applicant is considered as a holder.

The applicant is a business entity, legal entity (or an authorized person acting on its behalf) that has applied for the registration of a medical device and obtained a certificate from the regulatory authority of Uzbekistan.

Chapter 2 Registration Flow

Chapter 3 Registration Cycle, Official Fee

Registration Cycle

Official Fee

The official fee will be determined by Medical Device Regulatory Authority of the Republic of Uzbekistan after determining the risk level of the target device.

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:

①Registration of the product registration approach takes 7-9 months and requires the submission of CTD dossiers, samples and reference standards for laboratory tests;

②The 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.