In-vitro devices registration in Uzbekistan
IVD regulatory affairs in Uzbekistan
Many great opportunities, with RedMed
In-vitro devices approval for Uzbekistani market could follow one of the ways:
- a fast-track for the devices registered within EMA/CE, FDA, PMDA (Japan), MHRA (UK), MFDS (Korea), TGA (Australia), Health Canada;
- and a full-length registration for all other devices.
The registration certificate in Uzbekistan is issued for 5 years, with easy renewal process.
With the RedMed team to help, the registration will take 3-9 months, depends on a fast-track route and the MDs complexity.
Note: both IVDD and IVDR are accepted equally.
Only those manufacturers and distributors who hold a GMP/GDP certification will be allowed to participate in state procurement.
Registration Steps for IVD
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.
For IVD products, among other, we require these:
- Analytical performance reports (accuracy, precision, linearity, LoD/LoQ, specificity, interference studies);
- Clinical performance / clinical correlation data (depending on analyte risk level);
- Stability studies (shelf-life, open-vial stability);
- Metrological characteristics (for analyzers, calibrators, control materials);
- Reagent composition, safety data sheets (SDS), and shelf-life justification;
- Labeling for reagent kits, calibrators, controls, analyzers;
- Verification protocols for automated analyzers (when applicable).
All materials meticulously translated and notarized locally— delivered ready for submission.
Our dedicated manager gives all the explanations on the documents, notarization requirements, as partnering with RedMed means fewer uncertainties and a faster route to the market.
RedMed creates technical file for each analyte and analyzer/calibrator, IfU 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 fast-track registration in just 45 days - express entry into the Uzbek market.
Certificates participating:
- 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 a 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. Initial Dossier and Samples for the Committee.
Uzbekistan exercises a strict policy on samples review. Each device applied in the Application for registration must be presented for the Regulator`s review.
For IVDs this includes:
- Full reagent kits for each analyte under the registration;
- Calibrators and control materials (if included in the IFU);
- Consumables and cartridges used by the analyzer;
- Analyzer unit (if applicable) for functional demonstration.
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 laboratories regarding the device’s performance and analytical reliability.
We support you fully by engaging trusted users of your IVD system and preparing the necessary performance and usability reports.
Following this stage, the registration dossier must be updated and resubmitted for renewal.
The good news: state fee for renewal are reduced by 50%, making the process 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 3 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
//QR-Markings for Medical Devices in Uzbekistan
As of 2025, medical devices included in the official Government list cover the following HS codes:
- 9018 – medical instruments and equipment
- 9019 – mechanical therapy equipment, massage devices
- 9021 – orthopedic devices, dental devices
- 9022 – radiology and imaging equipment
- 3006 – selected medical consumables
RedMed is a registered operator of QR-markings for local circulation and traceability.
ASL BELGISI is Uzbekistan’s mandatory product marking system introduced in 2022 and actively implemeted in various goods groups. The system aims to ensure authenticity, traceability, 'best before' date compliance and transparency for selected categories of medical devices.
We check each device for the ASL BELGISI requirement and notify you.
To participate in the ASL BELGISI system, local AR handles system registration with locally provided E-signature "e-imzo", requests marking code issue and distribution, data submission, and continuous compliance.
Marking must be applied to each individual unit. All of medical devices falling under the ASL BELGISI codification must be marked before importation.
RedMed supports companies end-to-end: AR services, onboarding to the ASL BELGISI portal, code management, workflow integration, and full post-market compliance - so, an absolute no-brainer for manufacturers.
Frequently Asked Questions about in-vitro devices registration in Uzbekistan
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.
Additionally, the AR files devices within the ASL BELGISI national QR-Marking system - if the devices require such traceability.
RedMed provides In-Country Regulatory Representative services, ensuring compliance and satisfying the Uzbekistani Regulator`s need and Manufacturer`s request.
Q.: Is the Holder = the Distributor?
A.: The Regulator doesn`t require any information on distributors to be stated in the dossier, or in the Registration Certificate. The manufacturer is free to appoint any number of distributors and change them without notifying hence managing market freely. The Registration Certificate Holder in Uzbekistan has no commercial rights to the device, and doesn`t require to report commercial results to state bodies - the AR performs strictly legal, regulatory functions.
However, any change of the Holder`s data like address change, phone number addition, email update requires dossier update.
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).
Q.: Do we need to register devices separately?
A.: Yes. In Uzbekistan, each analyte, calibrator and control is treated as a separate medical device and must be registered under its own Registration Certificate. Even if the analytes used on the same analyzer, each assay has its own intended use, methodology and risk profile — therefore they cannot be combined into one certificate. If several reagents are manufactured and supplied strictly as one inseparable kit with a single intended use, one SKU, one IFU, and unified stability data, then we are good to register them under one Registration Certificate. However, they have to function as a single diagnostic system. It will be imported as one inseparable set, too.
Q.: My devices being produced in Korea, but not registered within Korean FDA yet. Could we apply for registration in Uzbekistan?
A.: Uzbekistan does not allow the registration of medical devices that lack registration in their country of origin. The Regulator asks for initial Registration Certificate being translated to Uzbek and provided for review.
RedMed is able to introduce manufacturers to contract manufacturing sites in Uzbekistan, compliant with GMP and ISO 13485, suitable for your device type (considering sterility category, presence of biological agents, 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 CIS countries, Uzbekistani regulator exercises a comfortable policy and
doesn`t require any inspection at all.
Yet, the country`s Government intends to introduce a mandatory inspection for first-time registrations in the future - we will update our F.A.Q. accordingly.
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 all-in.
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% of your initial registration fee paid.
For more information in regards of medical devices` regulatory affairs in Uzbekistan, write us:
hello@red-med.ru or use chat down right.
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 the 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 tax number, legal address, and contact information 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.
Additionally, the AR files devices within the ASL BELGISI national QR-Marking system - if the devices require such traceability.
RedMed provides In-Country Regulatory Representative services, ensuring compliance and satisfying the Uzbekistani Regulator`s need and Manufacturer`s request.
Q.: Is the Holder = the Distributor?
A.: The Regulator doesn`t require any information on distributors to be stated in the dossier, or in the Registration Certificate. The manufacturer is free to appoint any number of distributors and change them without notifying hence managing market freely. The Registration Certificate Holder in Uzbekistan has no commercial rights to the device, and doesn`t require to report commercial results to state bodies - the AR performs strictly legal, regulatory functions.
However, any change of the Holder`s data like address change, phone number addition, email update requires dossier update.
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).
Q.: Do we need to register devices separately?
A.: Yes. In Uzbekistan, each analyte, calibrator and control is treated as a separate medical device and must be registered under its own Registration Certificate. Even if the analytes used on the same analyzer, each assay has its own intended use, methodology and risk profile — therefore they cannot be combined into one certificate. If several reagents are manufactured and supplied strictly as one inseparable kit with a single intended use, one SKU, one IFU, and unified stability data, then we are good to register them under one Registration Certificate. However, they have to function as a single diagnostic system. It will be imported as one inseparable set, too.
Q.: My devices being produced in Korea, but not registered within Korean FDA yet. Could we apply for registration in Uzbekistan?
A.: Uzbekistan does not allow the registration of medical devices that lack registration in their country of origin. The Regulator asks for initial Registration Certificate being translated to Uzbek and provided for review.
RedMed is able to introduce manufacturers to contract manufacturing sites in Uzbekistan, compliant with GMP and ISO 13485, suitable for your device type (considering sterility category, presence of biological agents, 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 CIS countries, Uzbekistani regulator exercises a comfortable policy and
doesn`t require any inspection at all.
Yet, the country`s Government intends to introduce a mandatory inspection for first-time registrations in the future - we will update our F.A.Q. accordingly.
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 all-in.
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% of your initial registration fee paid.
For more information in regards of medical devices` regulatory affairs in Uzbekistan, write us:
hello@red-med.ru or use chat down right.
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