🇺🇿 Uzbekistan medical device regulatory data

Under Article 16 of the Law "On Medicinal Products and Pharmaceutical Activity", information on medicines and medical-purpose products is provided in the procedure established by the Ministry of Health, while advertising of medicines and medical-purpose products is carried out in the procedure established by (general) legislation.

Devices manufactured while the certificate was valid may undergo quality control, be imported and sold for 180 calendar days after the certificate expires, and used until their shelf life expires; the same 180-day rule applies after changes and after extension.

The device registration certificate is issued for a validity of five years. Under PF-137, registration certificates previously issued for an indefinite term are also capped at five years from the decree's entry into force.

The certificate validity extension application must be filed within nine months before expiry and is processed under the registration procedure; where no quality-related changes were made, laboratory testing is not performed but the devices undergo mandatory post-market control, and circulation and import are not suspended during extension. Extension applications must be accompanied by Uzbek clinics' conclusions on the device's safety and efficacy.

State registration of medical devices and issuance of registration certificates is carried out by the State Institution "Centre for Pharmaceutical Products Safety" («Фармацевтика маҳсулотлари хавфсизлиги маркази») under the Ministry of Health of the Republic of Uzbekistan.

Presidential Decree PF-137 of 19.08.2025 consolidated medical products and medical equipment into a single category of "medical devices" (тиббий жиҳозлар), classified into four safety (risk) levels, from 1 January 2026.

Where information in the registration documents changes during the certificate's validity or extension, the applicant must submit a change application through the information system with documents, samples and standards as needed; the Centre refuses changes that may negatively affect the device's quality, efficacy or safety. A fee for change applications is levied in MoH-approved amounts based on the Centre's costs. Change applications are reviewed within periods not exceeding 50 percent of the registration timelines (recognition-route registrations exempt).

Axis

Safety (potential risk) classes I, IIa, IIb and III (CM Resolution 738, Annex 2, para 4).

Classes

• Id

  i

  Label

  Class I

  Normalized Risk Level

  low

• Id

  iia

  Label

  Class IIa

  Normalized Risk Level

  medium

• Id

  iib

  Label

  Class IIb

  Normalized Risk Level

  high

• Id

  iii

  Label

  Class III

  Normalized Risk Level

  highest

Regulator

Ministry of Health

Notes

• Four classes: I low, IIa medium, IIb high, III highest; the four-level classification was mandated from 01.01.2026 by Presidential Decree PF-137 para 3(г).
• The class is declared by the applicant in the trilingual application (field 'Potensial xavf sinfi') and displayed in the State Register and on the certificate; class drives review time (60/90/120 working days), laboratory testing and clinical-study duties.

Devices are registered based on the positive results of clinical studies (PF-137); the Regulation exempts from clinical studies: class I devices; WHO-prequalified IVDs registered in cooperation with WHO; devices whose clinical studies were previously conducted in Uzbekistan; and recognition-route devices. The dossier for classes IIa, IIb and III must contain a clinical efficacy and safety report; the Centre determines study types and clinical bases, evaluates programs/protocols and sends a binding instruction via the information system. For class I, clinical efficacy documentation is not required except for sterile, measuring and invasive devices.

In vitro diagnostic devices («in vitro» ташхис тиббий жиҳозлари) are products used to examine, diagnose, monitor or establish compatibility of samples taken from the human body outside the organism, together with their consumables and components.

Medical devices (тиббий жиҳозлар) are instruments, apparatuses, equipment, devices, units and software permitted for use in medical practice for prevention, diagnosis, treatment, rehabilitation, monitoring or modification of body functions and contraception, which do NOT achieve their principal action by pharmacological, immunological or metabolic means.

Software intended for one or more medical purposes (diagnosis, monitoring, treatment, decision support) that performs its functions independently of a medical device — including platform software interoperating with other device or non-device software and IVD software — is defined as a medical device.

The applicant submits: the trilingual application form; registration documents in electronic form confirmed by the applicant's electronic digital signature per Annex 3 (device information incl. GMDN and UDI where available, manufacturer and site information, standards list, risk-management report, sterilization validation for sterile products, verification/validation test reports, biological evaluation, stability with state-language translation, adverse-event and withdrawal report plus post-market data collection/analysis plan, clinical safety/performance report for classes IIa-III, labeling and IFU); device samples; ISO 13485 certificate copy; declaration of conformity; certificate of registration in the country of manufacture or free-sale/export certificate with state-language translation; photos/catalogues; production inspection report; IP documents.

Submitted foreign certificates and registration certificates are verified for authenticity against the issuing authority's official registers (websites); where verification through open sources is impossible, all official documents must bear an apostille or consular certification.

Ministry of Health Order No. 10 of 20.05.2026 (registered by the Ministry of Justice No. 3888 on 07.07.2026) approves the Guidance (Йўриқнома) establishing the requirements for medical-device state-registration documents.

The applicant is the developer, manufacturer, registration-certificate holder, or a legal entity acting on their behalf under a power of attorney (ишончнома); where an application is filed through a representative, the power of attorney must be notarized, apostilled or consularly legalized.

From 1 January 2026 the retail-licence requirement for medical devices is abolished; retail proceeds by notifying the authorized body. Devices that must be certified may not be retailed without conformity certificates, and purchase, wholesale and retail of unregistered, substandard or counterfeit medicines and devices is prohibited.

Wholesale of medicines and medical devices may be carried out only by manufacturers and wholesale organizations holding a pharmaceutical-activity licence, under Ministry of Health rules; manufacturers may wholesale only devices they produce unless they hold a wholesale licence.

A fee (йиғим) is levied for reviewing a device-registration application; the amounts are approved by the Ministry of Health in agreement with the Ministry of Economy and Finance, the Business Ombudsman and the Chamber of Commerce and Industry, and are transferred to the Centre's personal treasury account. The fee is not refunded if the applicant withdraws the application or registration is refused.

No fee is charged for considering an application to re-issue the registration certificate (e.g. after reorganization or renaming with unchanged production site and technologies); the certificate is re-issued within 5 working days.

Registration dossier must include labeling and packaging information with color mock-ups (13-18 cm) and labeling text in the state (Uzbek) language, and for foreign manufacturers in Russian or English; the instructions for use / application instructions must be in the state language and in Russian or English. The Centre's Director agrees the instructions for use and labeling.

Cabinet of Ministers Resolution No. 738 of 24.11.2025 (devices Regulation in Annex 2) entered into force on 26.02.2026 and repeals CM Resolution No. 213 of 23.03.2018; all new applications, renewals and changes are examined under No. 738 from 26.02.2026.

Under Article 6 of the Law "On Medicinal Products and Pharmaceutical Activity" (No. 415-I of 25.04.1997, current version), medical-purpose products (изделия медицинского назначения) are subject to mandatory state registration; the registration procedure is determined by the Cabinet of Ministers.

The registration dossier must include a list of adverse events and withdrawal report and a plan for collecting and analyzing post-market data on the device's safety and efficacy. Devices extended without laboratory testing (no quality-related changes) undergo mandatory post-market control; quality control after expiry follows the documents approved during the certificate's validity.

From 26.02.2026 new state-registration applications for medical devices are filed through the Centre's information system «Darmon»; under the Regulation the documents are uploaded individually into the Centre's information system confirmed by the applicant's electronic digital signature. The my.gov.uz service page (service 330) still exists but cites the repealed CM Resolution No. 213 (2018).

MoH order (adopted 14.04.2026, registered 25.05.2026 No. 3838, in force 27.08.2026) sets the inspection procedure: document analysis within 15 working days, inspection program within 10 working days of the on-site decision, and inspection report (compliance or non-compliance) within 20 working days of completion. It does not apply to recognition-route devices, WHO-prequalified IVDs, or devices with a valid national ISO 13485-standard certificate whose production conditions were inspected during manufacture.

At registration the manufacturer's production quality system is inspected for conformity with the Uzbek national standard harmonized with ISO 13485; the dossier must include a copy of the current manufacturer's ISO 13485 QMS certificate issued by a valid accredited body, submitted before registration, and the inspection may run in parallel with registration. Exempt: recognition-route devices, WHO-prequalified IVDs registered in cooperation with WHO, and devices holding a current national ISO 13485-standard certificate.

If an inspected production site is found non-conforming with the national ISO 13485-harmonized standard, certificates of devices previously manufactured and registered at that site are suspended; validity is restored only after all non-conformities are eliminated, re-inspection is passed with positive results.

Suspension, cancellation and termination of the registration certificate follow Articles 32-34 of the Law "On Licensing, Permitting and Notification Procedures"; a single gross violation of the registration requirements of para. 9 (sub-paragraphs three-four and six-nine) is grounds for cancellation.

Devices undergo state registration either by the ordinary procedure (умумий тартиб) or by the recognition route (тан олиш йўли); recognition applies to devices already registered by specified foreign regulators.

The review deadlines exclude: the 30-working-day period to cure deficiencies behind an acceptance refusal; time awaiting a foreign regulator's reply to an official authenticity request; the 60-working-day period to cure deficiencies found in specialized expertise; time for conducting clinical studies; and time for the ISO 13485 production-conditions inspection.

Import without state registration is allowed for: devices for diagnosing and treating orphan diseases and for especially dangerous and epidemiologically dangerous infections imported by order of the Ministry of Health; and devices imported as external gratuitous aid and humanitarian assistance, which may enter and be used without registration subject to a positive Ministry of Health opinion.

Under MoH Order No. 24 (reg. No. 3749, 09.01.2026, in force 12.01.2026), medicines and devices in temporary shortage may be permitted for import and use in medical practice without state registration, subject to mandatory certification: a Permanent Working Group (with the Pharmaceutical Industry Development Agency, the Centre and the Procurement Center) decides, the product list is published on the Ministry website within 1 working day, importer proposals are submitted within 15 days, and quantities are sized at a 3-month minimum need.

Registration is not required for: reagents included in an IVD kit that cannot independently serve as a diagnostic means; custom-made devices (индивидуал буюртма); and devices imported for scientific research, preclinical and clinical studies, or demonstration at exhibitions, fairs and international congresses. Devices intended for export may be registered at the applicant's option.

Where the measuring and test means or test conditions required for device sample testing do not exist in Uzbekistan, the tests may be conducted at the foreign manufacturer's testing laboratory or at other foreign laboratories with the participation of the Centre's specialists.

The applicant has the right to complain, in the established procedure, against refusal of registration and against actions (inaction) of officials of the Centre. Refusal of registration is allowed only on the exhaustively listed grounds (uncured 60-day deficiencies, unreliable/false information, previously used samples, substantiated negative conclusions of laboratory/clinical/inspection/expert evaluations); refusal on other grounds, including inexpediency, is not allowed.

Deficiency notices are sent through the information system with 30 working days to cure acceptance-stage deficiencies (failure leads to a refusal decision, after which a new application is treated as newly filed) and 60 working days for specialized-expertise deficiencies; the certificate (Annex 4 form) or a reasoned refusal is sent to the applicant within 2 working days of the decision.

The Centre maintains the State Register of medicines and medical devices permitted in medical practice; it is published on the official websites of the Ministry of Health and the Centre and is open to everyone. Device entries show the device name (model, modification, version, format, size), country and manufacturer details with production-site addresses, field of application, certificate number and date, change date, potential risk class and device nomenclature (where available).

The trilingual application form and the registration certificate include the device's Unique Device Identification (UDI) and Global Medical Device Nomenclature (GMDN) "if available"; the Regulation defines UDI as a unique code created under international standards to identify a device and track it in circulation.

The applicant must continually submit to the Centre information on adverse effects (ножўя таъсирлар) that become known during use of the device in medical practice, in the procedure established by the Ministry of Health, and must immediately inform the Centre if the device's registration certificate is suspended, cancelled or withdrawn in other states or a certificate application was refused there.