
Registration of medical devices in Uzbekistan
Uzbekistan is a country with one of the most rapidly growing populations all over the CIS region. The country has started a massive modernization of the healthcare system in order to cover all people with medical services. For this purpose, in 2020, many legislation acts were adopted, including the Presidential Act about compulsory health insurance.
Nowadays, Uzbekistan is not a member of the EAEU, and all medical device registrations are done according to national law.
This is the chart of the authorized bodies that participate in the registration process:
And here are the main stages of the procedure, in total it should take no more than 155 working days:
The registration consists of 5 quite common for such a procedure steps:
Step 1- takes 5 working days: submit the registration dossier to the Center for Expertise for a revision
Step 2: After the experts’ conclusion, sign a contract wit the Center and pay a relevant fee
Step 3: Import and submit samples to the Center
Step 4 - takes about 130 working days: conduct functional trials in laboratories and receive a positive conclusion
Step 5 - takes about 20 working days: receive your registration certificate and get listed in the National registry
It is also important to keep in mind the following peculiarities:
- starting from 2021, there is a recognition procedure that allows to avoid conducting functional trials if a medical device has already been registered by one of these authorities: FDA (USA), CE (EU), PMDA (Japan), MFDS (Korea) or MHRA (UK)
- manufacturers do not need to carry out clinical trials
- there is no inspection of production sites
- RC has an expiry date and is valid for five years