Question 1

What regulation governs medical device registration in Uzbekistan?

Accepted Answer

Cabinet of Ministers Resolution No. 738 of 24 November 2025, in force from 26 February 2026. It replaces the previous framework.

Question 2

Which authority administers the regime?

Accepted Answer

The Center for Pharmaceutical Products Safety under the Ministry of Health of the Republic of Uzbekistan.

Question 3

How many risk classes are there?

Accepted Answer

Four. Classification is risk-based, and the class determines the evidence required and the review path.

Question 4

What is the recognition pathway?

Accepted Answer

A simplified route for devices already approved by a reference regulator. It reduces the dossier burden and shortens review compared with the national pathway.

Question 5

Which reference regulators are accepted?

Accepted Answer

US FDA, EU CE, UK MHRA, Japan PMDA and Korea MFDS. Approvals from other authorities do not open the recognition route.

Question 6

How long is a registration certificate valid?

Accepted Answer

Five years. Plan the renewal into the product lifecycle from the outset.

Question 7

Do I need a local Authorized Representative?

Accepted Answer

Yes, if the manufacturer is not established in Uzbekistan. The representative must be locally established and recorded on the State Register.

Question 8

How is the Authorized Representative appointed?

Accepted Answer

By a Power of Attorney issued by the manufacturer. Allow time for legalisation and certified translation before submission.

Question 9

What is e-imzo and do I need it?

Accepted Answer

e-imzo is the Uzbek national electronic signature. The electronic dossier submission must be signed with it, normally by the Authorized Representative.

Question 10

What goes into a registration dossier?

Accepted Answer

Technical documentation, clinical evaluation, labelling and instructions for use in the required languages, quality management system evidence, and — on the recognition route — the reference regulator's approval certificate.

Question 11

When does the new regime start applying?

Accepted Answer

26 February 2026. The Resolution itself was adopted on 24 November 2025.

Question 12

What happens after registration?

Accepted Answer

Post-market obligations begin: vigilance reporting, handling of field safety corrective actions, keeping the technical file current, and variations when the device, manufacturing site or representative changes.

Frequently asked questions

basics

classification

pathways

representation

process