Medical devices registration in Uzbekistan
Medical devices regulatory affairs agent in the Republic of Uzbekistan
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Uzbekistan`s population exceeds 38 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 2025, and grown 21% year-to-year, according to the State Pharmacy Committee.
Good news: Since January 1, 2025, the Сustoms clearance fee for medical devices has been abolished, what makes import to Uzbekistan cheaper and more streamlined.
Note: Only those manufacturers and distributors who hold a GMP/GDP certification will be allowed to participate in state procurement since 2024.
120 local manufacturers cover only 18% of the medical devices` market demand (data by the State Statistics committee). Primary import partners for medicinal products are Russia, China, India, Korea and Germany.
Good news: Since January 1, 2025, the Сustoms clearance fee for medical devices has been abolished, what makes import to Uzbekistan cheaper and more streamlined.
Note: Only those manufacturers and distributors who hold a GMP/GDP certification will be allowed to participate in state procurement since 2024.
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, the MDs complexity and eligibility for the fast-track.
Newest Government Decree no. 738 "On Approval of Regulations on the Procedure for State Registration of Medicines and on the Procedure for State Registration of Medical Devices" sets a regulatory framework for medical device registration in Uzbekistan since 24th of February 2026.
The new regulation modernizes the registration process a lot, and brings it closer to well-recognized regulatory practices like MDR and EAEU. A recognition-based Fast Track pathway remains available.
Key changes:
- Electronic submission only - dossiers must now be submitted electronically through the Regulator's portal using the Authorised Representative's local E-signature. Previously, we `ve been submitting documents in printed versions. As part of our Authorised Representative service in Uzbekistan, we provide our clients with the E-submission and pay the official government charges on their behalf.
- Enhanced technical and scientific assessment of the devices`s dossiers, focusing on safety, performance, and quality instead of previous "facts and tests results compilation" practice.
- Manufacturers' QMS and production controls documents now mandatory and require full ISO 13485 Audit report.
- Introduction of Inspection of manufacturing facilities. Just like Russia and Kazakhstan, Uzbekistan now applies this new requirement to Manufacturers with devices of classes 2a S, 2b and 3, who enter the market. Fast-track devices are exempt.
- More structured registration timings for regulatory review:
- 60 business days for Class 1 devices;
- 90 business days for Class 2a devices;
- 120 business days for Classes 2b and 3 devices.
This is an enhancement from previously applied term of 155 business days for most of devices. The above-mentioned timings, however, do not include: the shortcomings elimination identified in the documents during the review; clinical tests, if apply; a QMS Inspection, if applies.
Contact our team today for a tailored registration timeline and a detailed cost breakdown.
Our Regulatory Affairs team in Tashkent assists manufacturers with navigating through the Uzbekistani regulations on both new registrations and lifecycle AR management of existing devices - a turnkey regulatory service covering all of stages of the process.
Registration Steps
Step 1. Initial documents selection, notarization and translation
We require a specific set of the device`s documents including ISO 13485 certificate, a technical file, IFU, 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 our experienced team in Tashkent 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 the Decree of The President of the Republic of Uzbekistan dated 19.08.2025 No. UP-137.
Already CE, FDA or Japan-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
Although the fast-track regulatory review is completed within 15 business days, the overall registration process typically takes around 45 business days we mention, from dossier preparation to the Regulator's registration decision. The documentation requirements, official charges remain the same as under the standard registration pathway in Uzbekistan.
In order to get all of the express registration details within the State Pharmacy Committee of Uzbekistan, just drop us a message — via email or in the chat anytime.
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 2026, BCV is 412 000 UZS (33 USD). Depending on the device type and complexity, a single item may be priced at 30, 67, 80 BCVs, or even higher.
Additionally, each modification has its own fee, and usually being slightly cheaper than the "main device" 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.
On top of that, the Regulator charges Applicants with initial fee for the review, per each application.
We pay all fees at the very beginning of the registration process, in local currency and from our local company`s account.
Note: Official fees paid to the Regulator are non-refundable under any circumstances, including withdrawal or cancellation of the registration application by the Manufacturer.
Step 3. Samples for the Committee.
Uzbekistan exercises quite strict policy on samples review.
If you intend to register, say, a 600-items set, please be ready to provide all 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, or devices of risk class 1 (except for sterile, measuring or invasive devices of that risk class - these have to be presented), or the device following the fast-track procedure. The ISO 13485-complied devices are not exempted from the samples provision in Uzbekistan.
Step 4. The State Pharmacy Committee review.
The Regulator checks documents we created, does tests in its own laboratory, and issues the Registration certificate.
We answer all of commentaries and eliminate detected shortcomings to the dossier (if any, for sure), and collect your Registration Certificate from Tashkent`s Regulator Office.
Step 5. Post-marketing activities for further Registration extension.
After 5 years, the Regulator requires feedback from local clinics and hospitals regarding the device’s performance and effectiveness in order to proceed with the new registration term. We support you fully by engaging trusted users of your device and preparing the necessary reports on your behalf.
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 9 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 2026, 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 UDI system (Data Matrix 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 the Uzbekistani medical devices registration
Q.: Do I need a local Authorized Representative (AR) to complete the registration?
A.: Legal changes introduced in August 2025 have re-established the role of the AR for better state control: a foreign manufacturer remains a holder of the Registration, yet the Certificate is issued on a name of Uzbekistani company, with a local tax number, legal address, and contact information be placed to the IfUs and markings.
As well, the AR signs devices` documents with local E-signature 'e-imzo'.
The 'e-imzo' is obtained at a local tax body and issued for local tax residents exclusively.
Furthermore, whether the devices require State UDI-markings being applied on them, the AR must contract with the State operator of digital markings and register every batch imported.
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 designated as the official Holder of the Registration Certificate. A locally established company being stated as an Applicant/Authorized representative, and it can`t manage the Certificate without the manufacturer`s approval through 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 our local company is designated to provide AR functions on your behalf, we will be able to pay the State fee.
The State fee consists of a varying parts 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 expense.
Q.: My devices being produced in Korea, but not registered within Korean FDA yet. Could we apply for registration in Uzbekistan?
A.: Yes, medical devices with no registration at its manufacturer`s country can be registered in Uzbekistan - instead of the Registration certificate we will require a Free Sales certificate or Export Certificate, issued by your Chamber of Commerce and duly apostilled.
The Regulator asks for the country-of-origin document being translated to Uzbek and provided for review - we do it locally in Tashkent.
Q.: We seek for OEM opportunities in Uzbekistan. How could your team help?
A.: RedMed is able to establish your strategic partnership with a contract manufacturing site (OEM) in Uzbekistan, among general devices` and IVD manufacturers, as well as compliant with GMP and ISO 13485 and suitable for your device type. We consider sterility category, presence of a pharm composition in it, and packaging/labeling requirements. There is a number of local manufacturers good to produce medical devices of many types, from syringes and fillers to IVD reagents and MRIs. The medical devices may then be recognized as locally manufactured for participation in public procurement by state healthcare institutions.
Q.: Is manufacturing site inspection required during the registration in Uzbekistan?
A.: Unless your devices hold one of the 6 Registration certificates eligible for the "fast-track", or an ISO 13485, an on-site QMS Inspection is required. Basically, 95% of our applicants do not go for the QMS Inspection due to meeting of one or both requirements.
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 9-10 months before the initial certificate expires. It will allow the regulator to update the dossier smoothly and issue a new registration certificate without pauses and stress. RedMed team always warns our clients about the need to commence renewal procedure.
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.
All of items stated in the certificate will be required for the reviewing - being sent 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.: Legal changes introduced in August 2025 have re-established the role of the AR for better state control: a foreign manufacturer remains a holder of the Registration, yet the Certificate is issued on a name of Uzbekistani company, with a local tax number, legal address, and contact information be placed to the IfUs and markings.
As well, the AR signs devices` documents with local E-signature 'e-imzo'.
The 'e-imzo' is obtained at a local tax body and issued for local tax residents exclusively.
Furthermore, whether the devices require State UDI-markings being applied on them, the AR must contract with the State operator of digital markings and register every batch imported.
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 designated as the official Holder of the Registration Certificate. A locally established company being stated as an Applicant/Authorized representative, and it can`t manage the Certificate without the manufacturer`s approval through 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 our local company is designated to provide AR functions on your behalf, we will be able to pay the State fee.
The State fee consists of a varying parts 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 expense.
Q.: My devices being produced in Korea, but not registered within Korean FDA yet. Could we apply for registration in Uzbekistan?
A.: Yes, medical devices with no registration at its manufacturer`s country can be registered in Uzbekistan - instead of the Registration certificate we will require a Free Sales certificate or Export Certificate, issued by your Chamber of Commerce and duly apostilled.
The Regulator asks for the country-of-origin document being translated to Uzbek and provided for review - we do it locally in Tashkent.
Q.: We seek for OEM opportunities in Uzbekistan. How could your team help?
A.: RedMed is able to establish your strategic partnership with a contract manufacturing site (OEM) in Uzbekistan, among general devices` and IVD manufacturers, as well as compliant with GMP and ISO 13485 and suitable for your device type. We consider sterility category, presence of a pharm composition in it, and packaging/labeling requirements. There is a number of local manufacturers good to produce medical devices of many types, from syringes and fillers to IVD reagents and MRIs. The medical devices may then be recognized as locally manufactured for participation in public procurement by state healthcare institutions.
Q.: Is manufacturing site inspection required during the registration in Uzbekistan?
A.: Unless your devices hold one of the 6 Registration certificates eligible for the "fast-track", or an ISO 13485, an on-site QMS Inspection is required. Basically, 95% of our applicants do not go for the QMS Inspection due to meeting of one or both requirements.
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.
In case of reorganization or change of the name of the Manufacturer's production site without changing the location and technology, the AR is obliged to submit an application for reissue of the Certificate within one month. Such update takes 5 days to proceed.
Q.: How much in advance should we begin renewal of our Uzbek registration certificate?
A.: We strictly recommend to begin in 9-10 months before the initial certificate expires. It will allow the regulator to update the dossier smoothly and issue a new registration certificate without pauses and stress. RedMed team always warns our clients about the need to commence renewal procedure.
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.
All of items stated in the certificate will be required for the reviewing - being sent 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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