Medical devices registration in Uzbekistan
Medical devices regulatory affairs agent in the Republic of Uzbekistan
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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 3-9 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.
The 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 for the devices, IfU and markings in Uzbek, and 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", as well as The Decree of The President of the Republic of Uzbekistan dated 19.08.2025 No. UP-137 "On additional measures to regulate the circulation of medicines and medical devices".
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 established state fee for medical devices in Uzbekistan system can appear complex at first glance. Each device is listed separately in the State Services Catalogue and assigned its own tariff, expressed in Basic Calculated Values (BCV/БРВ). As of 2025, BCV is 412 000 UZS (33 USD). Depending on the device type and complexity, a single item may be priced at 30, 67, 80 BCV, or even higher.
Additionally, each modification has its own fee, and usually being slightly cheaper than the "main" fee.
If the modification`s GMDN code or purpose differs to the main device, another fee being applied. Overall, Uzbekistan exercises a fee-per-item system,not fee-per-certificate. This rather complicated fee structure applies to both fast-track and ordinary registration pathways.
When you need an exact state fee calculation for Uzbekistan, just drop us a message — via email or in the chat anytime.
We pay all fees at the very beginning of the registration process, in local currency and from our local company`s account.
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: The exception in presenting samples is large or complicated in assembly device.
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.: Historically, regulations allowed a comfortable Registration management - the foreign manufacturer was remaining the Holder of the Registration Certificate. This meant:
The 'e-imzo' is obtained at a local tax body and issued for local entities exclusively.
RedMed provides In-Country Regulatory Representative services through its fully established entity in Tashkent, ensuring compliance and satisfying the Uzbekistani Regulator`s need.
Q.: Who is listed as the Holder of the Registration Certificate in Uzbekistan?
A.: The Manufacturer is not designated as the official Holder of the Registration Certificate anymore, as it was before August 2025. Now, a locally established company being stated as a Holder, yet it can`t manage the Certificate without manufacturer`s approval thru the PoA.
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 soum, UZS. Once a local company we use for AR functions designated as it, we pay State fee on the manufacturer`s behalf.
The State fee consists of a varying part specific to the device and its complexity, number of items, and being paid for every modification.
The fees vary greatly, from 750 000 UZS ($66) 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.
RedMed is able find a contract manufacturing site in Uzbekistan, compliant with GMP and ISO 13485, suitable for your device type (considering sterility category, presence of pharmaceuticcal composition in it, and packaging/labeling requirements).
The device then can be classified as Uzbekistani-made.
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 - we`ll update F.A.Q. then.
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 3 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, unless the Manufacturer is good to provide CE, FDA certificates.
For more information in regards of medical devices` regulatory affairs in Uzbekistan, write us:
hello@red-med.ru
A.: Historically, regulations allowed a comfortable Registration management - the foreign manufacturer was remaining the Holder of the Registration Certificate. This meant:
- an Uzbekistani AR was not formally required to complete the registration,
- and, if designated, the AR’s name did not appear on the Registration Certificate or IfU.
However, legal changes introduced in August 2025 have re-established the role of the AR for better state control: a foreign manufacturer cannot be a holder of the Registration, as the Certificate is always issued on Uzbekistani company, having a local tax number, legal address, and contact information which will be placed to the IfUs.
As well, the AR signs documents with local E-signature 'e-imzo'.The 'e-imzo' is obtained at a local tax body and issued for local entities exclusively.
RedMed provides In-Country Regulatory Representative services through its fully established entity in Tashkent, ensuring compliance and satisfying the Uzbekistani Regulator`s need.
Q.: Who is listed as the Holder of the Registration Certificate in Uzbekistan?
A.: The Manufacturer is not designated as the official Holder of the Registration Certificate anymore, as it was before August 2025. Now, a locally established company being stated as a Holder, yet it can`t manage the Certificate without manufacturer`s approval thru the PoA.
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 soum, UZS. Once a local company we use for AR functions designated as it, we pay State fee on the manufacturer`s behalf.
The State fee consists of a varying part specific to the device and its complexity, number of items, and being paid for every modification.
The fees vary greatly, from 750 000 UZS ($66) 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.
RedMed is able find a contract manufacturing site in Uzbekistan, compliant with GMP and ISO 13485, suitable for your device type (considering sterility category, presence of pharmaceuticcal composition in it, and packaging/labeling requirements).
The device then can be classified as Uzbekistani-made.
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 - we`ll update F.A.Q. then.
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 3 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, unless the Manufacturer is good to provide CE, FDA certificates.
For more information in regards of medical devices` regulatory affairs in Uzbekistan, write us:
hello@red-med.ru
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