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Medical equipment registration in Uzbekistan
Equipment for clinics and laboratories, including service documents.
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Registration pathways
Since 01.01.2026 medical products and medical equipment are registered as medical devices (Decree UP-137, item 3). The procedure is set by the Regulation approved by Cabinet Resolution No. 738 (Annex 2). Medical devices fall into four risk classes: I, IIa, IIb, III (Regulation, item 4). Registration follows the standard procedure or recognition. The registration certificate is issued for five years (Regulation, item 8).
Standard registrationFor medical devices that do not qualify for recognition, including locally made devices.
For medical devices that do not qualify for recognition, including locally made devices.
Registration stages
- 1Determine the risk class under the Ministry of Health classification (Order No. 16 of 24.12.2025, MoJ reg. No. 3751 of 12.01.2026).
- 2File the application (Annex 2) and the full set of registration documents (Annex 3) electronically with the applicant's digital signature.
- 3Provide samples and the required control materials. Class I needs no samples, except sterile, invasive and measuring devices (item 10).
- 4Pass the primary review. 30 working days are given to fix the deficiencies found (item 17(a)).
- 5After a positive primary review, laboratory testing and the specialised review run in parallel. 60 working days are given to answer comments. Classes IIa, IIb and III need clinical studies unless there are grounds for exemption (item 17; Annex 1).
- 6Pass a manufacturing inspection against the national standard harmonised with ISO 13485, unless a valid national certificate exists or another exemption applies (item 17(e)).
- 7Receive the registration certificate with the agreed instructions and labelling: after a positive decision they are sent within two working days (items 18, 19).
- Review term
- Class I: 60 working days; IIa: 90; IIb and III: 120 working days.Постановление КМ № 738, прил. 2 (Положение о МИ), п. 14; приложение 1 к Положению
- Clock stops
- The 30- and 60-working-day deficiency periods, clinical trials, manufacturing inspection, and waiting for a foreign authority's reply.Постановление КМ № 738, прил. 2 (Положение о МИ), п. 14
- Class I
- No clinical trials; laboratory testing only for sterile, measuring and invasive devices.Постановление КМ № 738, прил. 2 (Положение о МИ), п. 17 «б», «г»
- Refusal over inspection
- Refusal if no inspection request is filed within 30 working days of scheduling, or if the applicant refuses an on-site inspection.Постановление КМ № 738, прил. 2 (Положение о МИ), п. 17 «д»
- Fee
- Set by the Ministry of Health in agreement with the Ministry of Economy and Finance, the business ombudsman and the Chamber of Commerce; not refunded on withdrawal or refusal. The act gives no figure.Постановление КМ № 738, прил. 2 (Положение о МИ), п. 13
- Certificate validity
- 5 yearsПостановление КМ № 738, прил. 2 (Положение о МИ), п. 8
Legal basis
- Постановление Кабинета Министров, № 738, 24.11.2025, прил. 2 (Положение о МИ), п. 4, 8, 10-20; приложения 1 и 3 к Положению
- Указ Президента, № УП-137, 19.08.2025, п. 3
- Приказ министра здравоохранения, № 16 (рег. МЮ № 3751 от 12.01.2026), 24.12.2025, Номенклатурная классификация и правила классификации по степени риска (в силе с 26.02.2026; изм. приказом рег. № 3751-1 от 02.05.2026)
Registration by recognitionThe device is registered by the FDA (USA), CE certificate issuing bodies (EU), the EMA (EU), PMDA (Japan), MFDS (Republic of Korea) or MHRA (UK), under item 4 of the Regulation approved by Cabinet Resolution No. 738.
The device is registered by the FDA (USA), CE certificate issuing bodies (EU), the EMA (EU), PMDA (Japan), MFDS (Republic of Korea) or MHRA (UK), under item 4 of the Regulation approved by Cabinet Resolution No. 738.
Registration stages
- 1Provide the valid foreign registration certificate or CE certificate and its expiry date (items 4, 9).
- 2File the application (Annex 2) and the full document set (Annex 3) electronically with the applicant's digital signature. Device samples and the materials of item 10(c), (d) are not required (items 10, 11).
- 3Pass the primary review in up to 2 working days and the specialised review in up to 11. The Center checks that foreign documents are genuine. If an official request gets no answer within 60 working days, registration is refused (Annex 1; item 17(c)).
- 4Decision and notice to the applicant. After a positive decision the certificate is sent through the information system within two working days (Annex 1; item 19).
- Review term
- 15 working daysПостановление КМ № 738, прил. 2 (Положение о МИ), п. 14; приложение 1 к Положению
- Testing and inspection
- No laboratory testing, clinical trials or manufacturing inspection.Постановление КМ № 738, прил. 2 (Положение о МИ), п. 8, 17 «б», «г», «д»
- EMA on the list
- Decree UP-77 removed EMA from the recognised list in Decree UP-6221 from 12.05.2026. Regulation No. 738 still names EMA.УП-77, прил. 4, п. 1 «а»; УП-6221, прил. 3, поз. 3; Постановление КМ № 738, прил. 2, п. 4
- Certificate validity
- 5 yearsПостановление КМ № 738, прил. 2 (Положение о МИ), п. 8
Class I: recognition based on a declaration of conformityClass I medical devices can be registered by recognition based on a declaration of conformity.
Class I medical devices can be registered by recognition based on a declaration of conformity.
Registration stages
- 1Confirm Class I under the Ministry's classification rules (MoJ reg. No. 3751).
- 2Prepare the declaration of conformity with safety and performance requirements (Annex 3 to the Regulation, item 4).
- 3File the application (Annex 2) and the full document set (Annex 3) electronically with the applicant's digital signature.
- In force from
- 12.05.2026УП-77, прил. 4, п. 1 «б» (дата вступления в силу по карточке lex.uz)
IVD: WHO prequalification and registration in epidemicsIn vitro diagnostic medical devices (IVD): devices prequalified by the WHO and registered in cooperation with it, and devices used in epidemics and pandemics of dangerous infections.
In vitro diagnostic medical devices (IVD): devices prequalified by the WHO and registered in cooperation with it, and devices used in epidemics and pandemics of dangerous infections.
Registration stages
- 1File the application (Annex 2) and the full document set (Annex 3) electronically with the applicant's digital signature.
- 2Pass the primary review in up to 10 working days and the specialised review in up to 48. No laboratory testing, clinical studies or manufacturing inspection (item 17; Annex 1).
- 3Decision and notice to the applicant within 2 working days (Annex 1).
- Term for WHO-prequalified
- 60 working daysПостановление КМ № 738, прил. 2 (Положение о МИ), п. 14; приложение 1 к Положению
- Epidemic IVDs
- 30 working days; one-off registration for 1 year.Постановление КМ № 738, прил. 2 (Положение о МИ), п. 14
Oncology: registration by recognition from the Council's listFor medical devices not made in Uzbekistan and approved for medical use abroad, including those with a declaration of conformity. They must be intended for the Republican Specialised Scientific and Practical Medical Centre of Oncology and Radiology and be on the list approved by the Council.
For medical devices not made in Uzbekistan and approved for medical use abroad, including those with a declaration of conformity. They must be intended for the Republican Specialised Scientific and Practical Medical Centre of Oncology and Radiology and be on the list approved by the Council.
Registration stages
- 1The device is put on the list approved by the Coordinating Council for cancer control projects.
- 2State registration by recognition.
- 3Import subject to certification in the set procedure, with quality control and identification on selected parameters.
- In force from
- 25.06.2026ПП-238 (дата вступления в силу по карточке lex.uz)
- Review term
- Not set.ПП-238, п. 8 «з»
Import and use without registrationRegistration exemptions (item 5), orphan and outbreak devices ordered by the Ministry of Health, humanitarian aid (item 6), temporary shortages (MoJ reg. No. 3749).
Registration exemptions (item 5), orphan and outbreak devices ordered by the Ministry of Health, humanitarian aid (item 6), temporary shortages (MoJ reg. No. 3749).
Registration stages
- 1Check exemptions: reagents inside IVD kits, custom-made devices, devices for research, clinical trials and exhibitions (item 5).
- 2Orphan devices and devices against highly dangerous and epidemic infections are imported on a Ministry order; humanitarian aid needs a positive Ministry conclusion (item 6).
- 3For shortages, Order 3749 applies: working-group decision, published list, importer selection, certification (except devices not subject to mandatory certification) (items 9-19).
- Research and exhibitions
- The exemption was added by Decree UP-74, in force since 07.05.2026.Постановление КМ № 738, прил. 2, п. 5 (в ред. УП-74, прил., п. 13)
- Export
- Export-only devices are registered only at the applicant's choice.Постановление КМ № 738, прил. 2, п. 5
Related procedures
- Renewal of the registration certificate (re-registration)The renewal application is filed within the nine months before the certificate expires. The procedure follows the registration rules. If no quality-related changes were made to the registration documents, laboratory testing is skipped; the device then goes through mandatory post-marketing quality control. Circulation and import are not suspended during renewal. Opinions of Uzbek clinics on the device's safety and effectiveness are attached. For 180 calendar days after renewal, production, import, quality control and sale under the previous documents are allowed, and circulation until the shelf life ends.Постановление КМ № 738, прил. 2, п. 28; приложение 3 к Положению, примечание
- Changes to the registration documentsThe application is reviewed in no more than 50% of the registration term (not for devices registered by recognition). An extra contract manufacturing site is added after laboratory testing and an inspection against the national standard harmonised with ISO 13485. The fee is set by the Ministry of Health. For 180 calendar days after the change, production, import, quality control and sale under the previous data are allowed, and circulation until the shelf life ends.Постановление КМ № 738, прил. 2, п. 23-25
- Certificate reissueAfter a reorganisation or a name change, with the same manufacturing site and technology, the application is filed within one month. Reissue takes up to 5 working days; no fee is charged.Постановление КМ № 738, прил. 2, п. 26-27
- Suspension and cancellationArticles 32-34 of the Law on licensing, permit and notification procedures apply. If an inspection finds the manufacturing site out of line with the national standard harmonised with ISO 13485, certificates for that site's devices are suspended. They resume after all non-conformities are fixed and a repeat inspection passes.Постановление КМ № 738, прил. 2, п. 17 «д», 29-30
- Oncology reagentsReagents for immunohistochemical, molecular and genetic tumour testing skip clinical-laboratory trials at registration.Постановление КМ № 738, прил. 2, п. 15
- Conformity certificate and ISO 13485From 01.07.2027, a conformity certificate for a medical device requires the manufacturer's certificate under the national ISO 13485 standard. Not required for recognition-registered, WHO-prequalified, and Ministry-ordered orphan and outbreak devices.УП-137, п. 5 «б», п. 6
How registration works
Consultation
We study the device and documents and set the timeline and cost.
Contract
We fix the scope, schedule and people responsible.
Dossier
We prepare the documents, translate them and compile the dossier to the set requirements.
Submission and review
We submit the dossier and follow the expert review.
Certificate
We hand over the certificate and help plan its renewal.
Registration package
- Technical file and equipment passport
- Operation and service manual
- Manufacturer's quality system certificates
- Test reports
The exact list depends on the product. We check your documents at the consultation.
Legislation
Acts from the knowledge base for this product type.
- Presidential Resolution · No. PP-238 · 24 June 2026Improving prevention, early detection and treatment of cancer
- Presidential Decree · No. UP-77 · 5 May 2026Improving management efficiency in the healthcare system
- Order of the Minister of Health · No. 12 · 27 April 2026Amendments to medical-device nomenclature and risk-classification rules
- Order of the Minister of Health · No. 2 · 14 April 2026Procedure for inspecting the manufacturing conditions of medical devices during state registration
- Order of the Minister of Health · No. 16 · 24 December 2025Medical-device nomenclature and risk classification
- Cabinet of Ministers Resolution · No. 738 · 24 November 2025State-registration procedures for medicines and medical devices
- Presidential Decree · No. UP-137 · 19 August 2025Additional measures regulating the circulation of medicines and medical devices
- Order of the Minister of Health · No. 6 · 28 July 2025Amendments to the list of medicines and devices allowed for use and import without state registration subject to mandatory certification