Medical devices registration in Uzbekistan
Medical devices regulatory affairs agent in the Republic of Uzbekistan
Many great opportunities, with RedMed
Uzbekistan`s population exceeds 36 million people, with 3 million living in its vibrant capital, Tashkent. Medical devices consumption rises accordingly - the market`s volume is $1,8 B in 2024, and grown 21% year-to-year, according to the State Pharmacy Committee.
120 local manufacturers cover only 18% of the medical devices` market demand (data by the State Statistics committee).
Primary import partners for medicine are Russia, China, India, Korea and Germany.
The registration certificate for medical devices in Uzbekistan is issued for 5 years, with easy renewal process
With the RedMed team to help, the registration shall take 2-9 months, depends on a risk class and the MDs complexity.
Note: Only those manufacturers and distributors who hold a GMP/GDP certification will be allowed to participate in state procurement since 2024.
Registration Steps
Step 1. Initial documents selection, notarization and translation
We require an ISO 13485 certificate, a technical file, the device’s registration certificate from its country of origin, and several supporting reports.
To simplify the process, we provide you with a customized, class-specific checklist tailored to your device’s safety class — ensuring you know exactly what’s needed.
All materials meticulously translated into Uzbek and notarized—delivered ready for submission.
Partnering with RedMed means fewer uncertainties and a faster route to the market.
RedMed creates technical file, IfU in Uzbek, application for the registration - all based on requirements of Resolution of the Cabinet of Ministers of the Republic of Uzbekistan dated 23.03.2018 No. 213 'On the procedure for state registration of medicines, medical devices and medical equipment and the issuance of a registration certificate'.
Already CE, FDA, MHRA, or PMDA certified? We unlock express registration in just 45 days—fast-tracked entry into the Uzbek market.
Certificates accepted:
- Food and Drug Administration (FDA), USA;
- Conformité Européenne (CE), EU;
- European Medicines Agency (EMA), EU;
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan;
- Ministry of Food and Drug Safety (MFDS), Republic of Korea;
- Medicines and Healthcare products Regulatory Agency, (MHRA), UK
Step 2. State fee calculation and payment.
The state fee is based on a medical device safety class, a number of items going into one registration certificate, its sterility and operational scope. When the fee is due, the Committee accepts the device`s dossier for review and issuing a Registration Certificate.
Step 3. Samples for the Committee.
Uzbekistan exercises quite strict policy on samples review.
If you intend to register, say, 600 items, be ready to provide these 600 items to the Regulator. The samples later returned. Complete or partial absence of samples will lead to the return or cancellation of the dossier. Our team handles logistics, returns and customs clearance - so you don`t have to.
Note: If your device holds one of the 6 mentioned registration certificates, the samples won`t be requested for reviewing.
Step 4. The State Pharmacy Committee reviews the application
and issues the certificate.
We collect your Registration Certificate from Tashkent`s Regulator Office.
Step 5. Post-marketing activities for further Reg Cert extension.
After 5 years, the Regulator requires feedback from local clinics and hospitals regarding the device’s performance and effectiveness. We support you fully by engaging trusted users of your device and preparing the necessary reports.
Following this stage, the registration dossier must be updated and resubmitted for renewal. The good news: state fees for renewal are reduced by 50%, making the process both efficient and cost-effective.
Ready to enter Uzbekistan's $1.8 B growing market? Contact RedMed today for a free consultation and tailored registration roadmap:
hello@red-med.ru or via chat down on the right
Time to get: up to 9 months
Average time for the registration of medical devices in Uzbekistan with RedMed is 2 to 9 months. The registration is valid for 5 years and must be renewed at least 3 months before expiration.
The state registration for medical devices in Uzbekistan conducted by
"Center For Safety Of Pharmaceutical Products" of the Ministry of Healthcare.
The regulator`s website is www.uzpharm-control.uz
Frequently Asked Questions about the Uzbekistani medical devices registration
Q.: Do I need a local Authorized Representative (AR) to complete the registration?
A.: A local AR is not strictly required to complete the registration process, and if designated, its name does not appear on the Registration Certificate. The locally approved Instructions for Use will indicate the company responsible for product quality and include contact details for communication with the manufacturer. Yet legal developments, as of 2025, build a path for future stronger role of AR in regulatory affairs - we wait for a new law to be passed.
RedMed offers AR services with a local entity based in Tashkent on demand.
Q.: Who is listed as the Holder of the Registration Certificate in Uzbekistan?
A.: The Manufacturer is always designated as the official Holder of the Registration Certificate. The involvement of a local Authorized Representative does not impact the Manufacturer's authority over commercial or marketing activities.
Q.: What are state fees like and is it possible for us to pay state fees directly to the Regulator?
A.: The State fee is paid in Uzbek sum, UZS. A local company we use for AR functions has an UZS account for such transactions.
The State fee consists of a fixed part:
3 750 000 UZS ($300) for the Application, 750 000 UZS ($60) for the State Letterhead.
The varying part consists of state fee specific to device registered, and paid for every modification. The fees vary greatly, from 750 000 UZS ($60) to 129 000 000 UZS ($9900).
Ask us for help with assessing your total fee.
Q.: My devices being produced in Korea, but not registered within Korean FDA yet. Could we apply for registration in Uzbekistan?
A.: Medical devices with no registration at its manufacturer`s country can not be registered in Uzbekistan at the moment. The Regulator asks for initial Registration Certificate being translated to Uzbek and provided for review.
Q.: Is manufacturing site inspection required during the registration?
A.: Unlike most of post-Soviet countries, Usbekistani regulator doesn`t require an inspection.
The country`s Government intends to introduce a mandatory inspection for the first-time registrations in the future.
Q.: How much time does the registration take, from A to Z?
A.: For a general registration, all of works can fit in 9 months including dossier compilation and the regulatory reviewing. For an express registration - FDA, CE, EMA, PMDA, MFDS, MHRA registration certificate holders - it will take up to 2 months.
Q.: Is the express registration certificate still valid for 5 years, or shorter?
A.: So far, any registration certificate issued in Uzbekistan valid for 5 years.
Q.: How much in advance should we begin renewal of our Uzbek registration certificate?
A.: We strictly recommend to begin in 3-4 months before the initial certificate expires. It will allow the regulator to smoothly update the dossier and issue a new registration certificate without pauses and stress.
Q.: What else should I know when I renew my registration certificate for Uzbekistan?
A.: The state fee for the renewal will approximate 50-60% of your initial registration fee paid.
All of items stated in the certificate will be required for the reviewing - sent again to Tashkent.
For more information in regards of medical devices` regulatory affairs in Uzbekistan, write us:
hello@red-med.ru
A.: A local AR is not strictly required to complete the registration process, and if designated, its name does not appear on the Registration Certificate. The locally approved Instructions for Use will indicate the company responsible for product quality and include contact details for communication with the manufacturer. Yet legal developments, as of 2025, build a path for future stronger role of AR in regulatory affairs - we wait for a new law to be passed.
RedMed offers AR services with a local entity based in Tashkent on demand.
Q.: Who is listed as the Holder of the Registration Certificate in Uzbekistan?
A.: The Manufacturer is always designated as the official Holder of the Registration Certificate. The involvement of a local Authorized Representative does not impact the Manufacturer's authority over commercial or marketing activities.
Q.: What are state fees like and is it possible for us to pay state fees directly to the Regulator?
A.: The State fee is paid in Uzbek sum, UZS. A local company we use for AR functions has an UZS account for such transactions.
The State fee consists of a fixed part:
3 750 000 UZS ($300) for the Application, 750 000 UZS ($60) for the State Letterhead.
The varying part consists of state fee specific to device registered, and paid for every modification. The fees vary greatly, from 750 000 UZS ($60) to 129 000 000 UZS ($9900).
Ask us for help with assessing your total fee.
Q.: My devices being produced in Korea, but not registered within Korean FDA yet. Could we apply for registration in Uzbekistan?
A.: Medical devices with no registration at its manufacturer`s country can not be registered in Uzbekistan at the moment. The Regulator asks for initial Registration Certificate being translated to Uzbek and provided for review.
Q.: Is manufacturing site inspection required during the registration?
A.: Unlike most of post-Soviet countries, Usbekistani regulator doesn`t require an inspection.
The country`s Government intends to introduce a mandatory inspection for the first-time registrations in the future.
Q.: How much time does the registration take, from A to Z?
A.: For a general registration, all of works can fit in 9 months including dossier compilation and the regulatory reviewing. For an express registration - FDA, CE, EMA, PMDA, MFDS, MHRA registration certificate holders - it will take up to 2 months.
Q.: Is the express registration certificate still valid for 5 years, or shorter?
A.: So far, any registration certificate issued in Uzbekistan valid for 5 years.
Q.: How long does it take for the updates to the registration certificate to be applied?
A.: It usually takes 2 to 3 months for a full application of updates to existing certificate.
Q.: How much in advance should we begin renewal of our Uzbek registration certificate?
A.: We strictly recommend to begin in 3-4 months before the initial certificate expires. It will allow the regulator to smoothly update the dossier and issue a new registration certificate without pauses and stress.
Q.: What else should I know when I renew my registration certificate for Uzbekistan?
A.: The state fee for the renewal will approximate 50-60% of your initial registration fee paid.
All of items stated in the certificate will be required for the reviewing - sent again to Tashkent.
For more information in regards of medical devices` regulatory affairs in Uzbekistan, write us:
hello@red-med.ru
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