Registration of Medical Devices in Uzbekistan

The legal regulation of the circulation of medical devices, including medical technology, equipment and other related products, is of particular importance for the healthcare system, since medical devices are directly used in prevention, diagnosis, treatment, rehabilitation, monitoring of a patient's condition, as well as in supporting medical processes. Unlike ordinary industrial products, a medical device has increased social and legal significance: defects, incorrect labeling, insufficient clinical evaluation or non-compliance with safety standards may directly harm human life and health.

In the Republic of Uzbekistan, the state registration of medical devices is not merely an administrative procedure for admitting products to the market, but also a comprehensive mechanism for preliminary control of the quality, safety and effectiveness of a device. The adopted Regulation on the Procedure for State Registration of Medical Devices, approved by Resolution of the Cabinet of Ministers of the Republic of Uzbekistan No. 738 dated 24 November 2025, establishes a modern regulatory model focused on a risk-based approach, digitalization of procedures, recognition of international registration results and strengthening of the post-registration responsibility of the registration certificate holder.

Concept of a Medical Device and Scope of Registration Regulation

The Regulation establishes a broad definition of a medical device. Medical devices include products, apparatuses, instruments, devices, equipment, complexes and software permitted for use in medical practice for prevention, diagnosis, treatment, rehabilitation, support of such processes, determination, restoration, replacement or modification of the condition and functions of the human body, monitoring and prevention of pregnancy. An essential qualifying feature is that such a device does not exert its principal pharmacological, immunological or metabolic action on the human body.

This definition has important practical significance because it allows medical devices and medicinal products to be distinguished. If the therapeutic effect is achieved primarily through pharmacological, immunological or metabolic action, the object should generally be regulated as a medicinal product. If, however, the principal function is achieved by mechanical, physical, diagnostic, software-based, measuring or other non-pharmacological means, the object may be classified as a medical device.

Software occupies a special place. The Regulation expressly classifies as medical devices software intended for one or more medical purposes, including diagnosis, monitoring, treatment and support in decision-making, where such software performs functions independently of medical devices or interacts with them. This reflects the modern trend of including digital health solutions, AI/ML systems, diagnostic platforms and clinical decision-support tools within the scope of medical regulation.

Objectives of State Registration of Medical Devices

The purpose of registration is to ensure the safety, effectiveness and quality of medical devices manufactured, imported, circulated or used in the territory of the Republic of Uzbekistan. The Regulation covers the entire life cycle of a device — from design to the final stage of operation. This approach corresponds to international practice, where registration is regarded as an instrument for protecting public interests, primarily public health. The regulator assesses not only the formal availability of documents, but also:

1. technical characteristics of the device;
2. the manufacturing process;
3. the quality management system;
4. laboratory test results;
5. clinical effectiveness and safety;
6. risk management;
7. labeling and operational documentation;
8. post-market safety data.

Subjects of the Registration Procedure

The Regulation identifies several key subjects of registration relations. The applicant is the developer, manufacturer, registration certificate holder or a legal entity acting on their behalf under a power of attorney. The registration certificate holder is a legal entity entitled to hold the registration certificate and responsible for the safety, quality and effectiveness of the medical device. The Center for Pharmaceutical Product Safety is the competent authority responsible for registration, examination, issuance of the certificate, maintenance of the information system and interaction with the applicant.

This distinction has practical significance in the contract manufacturing of medical devices and in technology transfer. Regulatory responsibility is distributed not only according to the formal criterion of holding the certificate, but also according to actual participation in the production and technological chain.

Classification of Medical Devices by Risk Level

One of the central elements of the Regulation is the risk-based classification of medical devices. The risk class affects the scope of documents, registration timelines, the need for laboratory testing, clinical investigations and manufacturing site inspection.

General Procedure and Registration by Recognition

The Regulation provides for two main models of state registration: registration under the general procedure, and registration by recognition. Registration by recognition applies to medical devices registered by authoritative foreign regulators, including the FDA of the United States, CE bodies in the European Union, EMA, PMDA of Japan, MFDS of the Republic of Korea and MHRA of the United Kingdom.

Recognition of foreign registration reduces the administrative burden on the applicant, since such devices do not require separate laboratory testing, clinical investigations or inspection of manufacturing conditions, provided that the conditions of the Regulation are met.

At the same time, recognition does not mean automatic admission of the device. The Center retains the authority to verify documents and the authenticity of foreign certificates, and to refuse registration where statutory grounds exist.

Registration Timelines

The Regulation establishes differentiated timelines for reviewing applications. Note that the review periods do not include periods granted for remedying deficiencies, waiting for a response from a foreign regulator, or conducting clinical investigations and manufacturing inspections.

Documents and Samples Required for Registration

For registration, the applicant submits an application in the prescribed form, an electronic version of the registration documents certified by an electronic signature, and samples of the medical device in the quantity necessary for testing. The Regulation prohibits requiring from the applicant documents and samples not provided for in the established list — a provision that limits administrative discretion and increases the predictability of the procedure. The registration dossier includes the following document blocks:

• Device information — intended use, description, types, composition, GMDN, UDI
• Manufacturing information — information about the manufacturer, manufacturing process, packaging and product release
• Risk management — risk management and analysis report
• Software — architecture, life cycle, cybersecurity, verification and validation
• Clinical evaluation — report on clinical effectiveness and safety
• Labeling — mock-ups, packaging, labeling text, instructions in Uzbek and Russian or English
• ISO 13485 — manufacturer's quality management system certificate
• IP documents — documents relating to trademarks, industrial designs or an opinion of the authorized body

The inclusion of IP documents in the registration dossier deserves special attention. Registration of a medical device may be refused where there is an opinion of the authorized body confirming infringement of intellectual property rights. Legal clearance of the trade name, design, and labeling therefore becomes a mandatory element of the registration strategy.

Laboratory Testing

Laboratory testing is aimed at confirming the safety and effectiveness of a medical device, covering electromagnetic compatibility, electrical safety and assessment of biological impact. Laboratory testing is not conducted for:

1. in vitro medical devices that have passed WHO prequalification and are registered in cooperation with WHO;
2. medical devices and components registered by recognition;
3. Class I medical devices, except sterile, measuring and invasive devices.

If the necessary testing facilities are unavailable in Uzbekistan, testing may be conducted in the laboratory of the foreign manufacturer or in other foreign laboratories with the participation of specialists of the Center.

Clinical Investigations and Clinical Evaluation

The Center decides whether registration is possible without clinical investigations or whether such investigations must be conducted. Clinical investigations are not required for Class I medical devices, in vitro devices that have passed WHO prequalification, devices that have previously undergone clinical investigations in Uzbekistan, and devices registered by recognition. This differentiated approach avoids an excessive burden for low-risk devices while maintaining strict control over devices that may directly affect patient health.

Inspection of Manufacturing Conditions and ISO 13485

During state registration, the quality system of manufacturing conditions is inspected for compliance with the national standard harmonized with ISO 13485, except for devices registered by recognition and WHO-prequalified in vitro devices. For devices manufactured under a contract or through technology transfer, the availability of an ISO 13485 certificate becomes particularly important.

Localization of medical device manufacturing in Uzbekistan or transfer of the technological process requires not only contractual documentation, but also a fully functioning quality system compliant with ISO 13485.

Grounds for Refusal of Registration

The Regulation establishes an exhaustive list of grounds for refusal. Refusal on other grounds, including reasons of inexpediency, is not permitted — a provision that strengthens the principle of legal certainty.

Validity, Renewal and Amendments

Following registration, a registration certificate is issued for a period of five years. An application for renewal must be submitted within nine months before expiry. If no qualitative changes have been made to the registration documents, laboratory testing is not repeated — quality is instead subject to mandatory post-market control.

If information in the registration documents changes during the validity period, the applicant must apply to the Center for amendments. Changes may concern the manufacturing site, labeling, instructions, software, technical characteristics, packaging, shelf life, and information about the manufacturer or certificate holder. Failure to notify the Center in a timely manner may be regarded as a violation of registration requirements.

Suspension and Cancellation of the Certificate

Violation of a number of registration requirements is recognized as a single gross violation and constitutes grounds for cancellation of the certificate. Such violations include failure to provide accurate information, failure to ensure quality and safety, non-compliance with ISO 13485, and failure to notify the Center of suspension, recall or refusal of registration in other countries. A registration certificate is therefore not an unconditional authorization — the certificate holder retains ongoing obligations to monitor safety, maintain quality and inform the regulator.