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.

From a scientific perspective, this model may be characterized as a regulatory model based on control over the product life cycle. It differs from narrow administrative authorization in that 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.

This approach corresponds to international practice in the regulation of medical devices, where registration is regarded as an instrument for protecting public interests, primarily public health.

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, which applies to the Center for Pharmaceutical Product Safety under the Ministry of Health of the Republic of Uzbekistan for registration of a medical device.

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 customer is a legal entity entitled to hold the registration certificate for medical devices manufactured with the involvement of another pharmaceutical manufacturing organization.

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. The Regulation expressly provides that responsibility for the safety, quality and effectiveness of devices manufactured under a contract or as a result of technology transfer rests with the customer, the technology transfer holder and the manufacturer. Consequently, 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. Medical devices are registered according to the following safety levels:

Class	Risk level	General description
Class I	Low risk	Devices with minimal potential impact on the patient’s health
Class IIa	Medium risk	Devices requiring a more detailed technical and clinical assessment
Class IIb	High risk	Devices with significant potential risk for the patient
Class III	Highest risk	The most critical devices requiring the strictest examination

The risk-based approach affects the scope of documents, registration timelines, the need for laboratory testing, clinical investigations and manufacturing site inspection. The higher the risk class, the stricter the requirements for evidence of safety and effectiveness.

General Registration Procedure and Registration by Recognition

The Regulation provides for two main models of state registration:

1. registration under the general procedure;
2. registration by recognition.

Registration by recognition applies to medical devices registered by authoritative foreign regulators or organizations, 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.

This model is of substantial importance for accelerating access to modern medical technologies in the Uzbek market. 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, the authenticity of foreign certificates and registration certificates, and to refuse registration where statutory grounds exist.

Registration Timelines for Medical Devices

The Regulation establishes differentiated timelines for reviewing applications:

Category of medical device	Review period
Registration by recognition	15 business days
In vitro devices used during epidemics and pandemics	30 business days
Devices prequalified by WHO	60 business days
Class I	60 business days
Class IIa	90 business days
Classes IIb and III	120 business days

At the same time, the review periods do not include periods granted for remedying deficiencies, waiting for a response from a foreign regulator, conducting clinical investigations and manufacturing inspections, as well as other periods expressly specified in the Regulation.

Accordingly, the nominal registration period may differ substantially from the actual calendar period, especially for high-risk devices, devices with an incomplete dossier, products with foreign certificates whose authenticity cannot be verified through open sources, and devices requiring clinical investigations.

Documents and Samples Required for Registration

For registration, the applicant submits:

1. an application in the prescribed form;
2. an electronic version of the registration documents certified by an electronic signature;
3. samples of the medical device in the quantity necessary for testing;
4. reference samples, control materials, special reagents, test strains, diagnostic test systems and other materials, where required for testing.

It is particularly important that the Regulation prohibits requiring from the applicant documents and samples not provided for in the established list. This provision has anti-corruption and rights-protective significance, since it limits administrative discretion of the regulator and increases the predictability of the procedure.

The list of registration documents includes, in particular:

Document block	Content
Device information	Intended use, description, types, composition, GMDN, UDI
Manufacturing information	Information about the manufacturer, manufacturing process, packaging and product release
Standards	List of standards or common specifications
Risk management	Risk management and analysis report
Sterilization	Sterilization validation, bioburden, endotoxins, packaging
Software	Architecture, life cycle, cybersecurity, verification and validation
Clinical evaluation	Report on clinical effectiveness and safety
Labeling	Mock-ups, packaging, labeling text
Instructions	Instructions in the state language and in 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. Therefore, the legal clearance of the trade name, design, labeling and other IP elements becomes not an optional, but a mandatory element of the registration strategy.

Laboratory Testing

Laboratory testing is aimed at confirming the safety and effectiveness of a medical device. As examples, the Regulation refers to electromagnetic compatibility, electrical safety and assessment of biological impact. Testing is conducted in laboratories for compliance with national or adopted international standards.

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 or conditions 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. This provision is of practical importance for complex high-tech equipment that cannot be tested locally.

Specialized Examination

Specialized examination is an in-depth analysis of technical data, the manufacturing process, risk management, test results and compliance of the device with applicable standards.

As part of the specialized examination, the Center:

1. analyzes the technical documentation;
2. assesses the safety, quality and effectiveness of the device;
3. verifies laboratory test reports;
4. where necessary, sends samples for additional testing;
5. verifies the authenticity of foreign certificates and registration certificates;
6. prepares an assessment report.

If deficiencies are identified, the applicant is granted 60 business days to remedy them. An incomplete response to an additional request may result in refusal to issue the registration certificate. This makes the quality of the initial registration dossier a critical factor for successful registration.

Clinical Investigations and Clinical Evaluation

The Regulation provides for analysis of the safety and effectiveness of medical devices based on scientific literature, previous clinical experiments and, where necessary, clinical investigation reports. The Center decides whether registration is possible without clinical investigations or whether such investigations must be conducted.

Clinical investigations are not required for:

1. Class I medical devices;
2. in vitro medical devices that have passed WHO prequalification;
3. devices that have previously undergone clinical investigations in Uzbekistan;
4. devices registered by recognition.

This regulation demonstrates a differentiated approach: clinical investigations are not applied automatically, but depend on the risk class, the availability of previous data and the international status of the device. This makes it possible to avoid an excessive burden for low-risk devices while maintaining strict control over devices that may affect patient health.

Inspection of Manufacturing Conditions and ISO 13485

One of the key elements of the new procedure is inspection of manufacturing conditions for compliance with the requirements of the national standard of the Republic of Uzbekistan harmonized with ISO 13485. ISO 13485 is the international quality management system standard for manufacturers of medical devices.

The Regulation provides that, during state registration, the quality system of manufacturing conditions is inspected, except for devices registered by recognition and in vitro devices that have passed WHO prequalification and are registered in cooperation with WHO.

For devices manufactured under a contract or through technology transfer, the availability of an ISO 13485 certificate becomes particularly important. The customer, the technology transfer holder and the manufacturer must have the relevant certificate. In addition, the organization that has accepted the technology transfer is subject to inspection control at least once a year.

From a practical standpoint, this means that 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 of registration. These include:

Ground for refusal	Practical significance
Failure to remedy deficiencies within 60 business days	The applicant must respond to the Center’s requests in a timely and complete manner
Inaccurate, incorrect or false information	Increases the importance of legal and technical verification of the dossier
Submission of a previously used sample	Requires control over the status and origin of samples
Negative conclusions based on testing, clinical investigations, inspection or examination	The device fails to confirm safety, quality or effectiveness
Non-compliance of at least one model, modification, version, format or size	Risk of refusal for the entire declared group of devices

It is especially important that refusal on other grounds, including reasons of inexpediency, is not permitted. This provision limits the regulator’s discretion and strengthens the principle of legal certainty.

Validity Period of the Registration Certificate and Renewal

Following registration, a registration certificate is issued for a period of five years. After the certificate expires, the sale and use in medical practice of devices manufactured during the validity period of the registration certificate is permitted.

An application for renewal of the certificate must be submitted within nine months before its expiry. Renewal is carried out in accordance with the procedure established for registration. However, laboratory testing is not conducted if no qualitative changes have been made to the registration documents. In such case, the quality of the devices is subject to mandatory post-market control.

This regulation is aimed at ensuring continuity in the circulation of medical devices and preventing artificial shortages of products due to administrative renewal.

Amendments to Registration Documents

If, during the validity period of the certificate, information contained in the registration documents changes, the applicant must apply to the Center for amendments and additions. If the changes may negatively affect the quality, effectiveness and safety of the device, the Center may refuse to introduce such amendments.

An application for amendments is reviewed within periods not exceeding 50 percent of the periods established for registration, except for devices registered by recognition.

From a practical standpoint, amendments may concern:

1. manufacturing site;
2. labeling;
3. instructions for use;
4. composition of the set;
5. software;
6. technical characteristics;
7. quality control methods;
8. packaging;
9. shelf life;
10. information about the manufacturer or certificate holder.

For manufacturers and importers, it is particularly important to classify changes in advance as substantial or non-substantial, since failure to notify the Center in a timely manner may be regarded as a violation of registration requirements.

Suspension, Cancellation and Termination of the Certificate

The Regulation provides that suspension, cancellation and termination of the registration certificate are carried out in accordance with the legislation on licensing, permitting and notification procedures. At the same time, violation of a number of registration requirements and conditions is recognized as a single gross violation and constitutes grounds for cancellation of the certificate.

Such violations include, in particular:

1. failure to provide accurate information;
2. failure to ensure quality, safety and effectiveness;
3. non-compliance with ISO 13485 requirements;
4. failure to provide information on adverse effects;
5. failure to notify the Center of suspension, recall or refusal of registration in other countries for reasons related to quality, effectiveness or safety.

Thus, a registration certificate is not an unconditional authorization for the entire period of its validity. The certificate holder retains ongoing obligations to monitor safety, maintain quality and inform the regulator.

Comparative Table of Medical Device Registration Procedures

No.	Criterion	Registration under the general procedure	Registration by recognition	Key difference
1	Legal nature of the procedure	Full national procedure for state registration of a medical device in Uzbekistan	Simplified registration based on recognition of registration issued by authoritative foreign regulators	Under recognition, the Center relies on the foreign regulatory assessment already conducted
2	Grounds for application	Applies to all medical devices unless they fall under the recognition procedure or another special procedure	Applies to devices registered by FDA, CE, EMA, PMDA, MFDS, MHRA	Recognition is possible only if registration by specified foreign authorities exists
3	Competent authority in Uzbekistan	State Institution “Center for Pharmaceutical Product Safety” under the Ministry of Health of the Republic of Uzbekistan	The same Center	The authority is the same, but the scope of review differs
4	Purpose of the procedure	Independent assessment of the safety, quality and effectiveness of the medical device	Confirmation of the possibility of admitting the device to the Uzbek market taking into account prior foreign registration	Under the general procedure, assessment is full; under recognition, it is limited
5	Categories of devices	Class I, IIa, IIb and III devices, including devices not registered by recognized foreign regulators	Devices registered by recognized foreign organizations	The general procedure has broader coverage
6	Risk classes	Timelines and scope of examination depend on the risk class: I, IIa, IIb, III	Risk class is considered, but the procedure is shortened	Under the general procedure, risk class significantly affects timing and scope of testing
7	General registration period	Class I — 60 business days; Class IIa — 90 business days; Classes IIb and III — 120 business days	15 business days	Recognition is significantly faster
8	Preliminary examination	Up to 5 business days for Class I; up to 10 business days for Classes IIa, IIb and III	Up to 2 business days	Preliminary review is shortened under recognition
9	Laboratory testing	Conducted, except for statutory exceptions	Not required	One of the main advantages of recognition
10	Laboratory testing period	Up to 33 business days for Class I; up to 45 business days for IIa; up to 65 business days for IIb and III	Not applicable	This stage is excluded under recognition
11	Specialized examination	Conducted in full: technical data, manufacturing process, risks, reports, standards	Conducted in reduced scope — up to 11 business days	Under recognition, examination focuses on document review and foreign registration
12	Clinical investigations	Required for Classes IIa, IIb and III unless exemption grounds exist	Not required	Recognition exempts from clinical investigations in Uzbekistan
13	Inspection of manufacturing conditions	Conducted for compliance with requirements of the national standard harmonized with ISO 13485	Not required	Manufacturing inspection is not conducted under recognition
14	ISO 13485	As a rule, the manufacturer’s quality system certificate is required; inspection may also be conducted	Certificate and foreign documents are checked, but inspection in Uzbekistan is not conducted	Under the general procedure, control over the quality system is deeper
15	Medical device samples	Submitted in the quantity necessary for testing, except for exceptions	Usually not required for testing because laboratory testing is not conducted	Recognition reduces the material burden on the applicant
16	Technical documentation	A full set of technical documentation is submitted	Registration dossier is submitted with emphasis on documents confirming foreign registration	Under recognition, the scope of actual technical review is smaller
17	Verification of foreign certificates	May be conducted if foreign documents are used	Central element of the recognition procedure	For recognition, confirmation of the authenticity of foreign registration is critical
18	Apostille / consular legalization	May be required if foreign documents cannot be verified through open sources	Particularly important because the procedure is based on foreign certificates and registration certificates	Under recognition, the risk of delay is higher where foreign documents are not verifiable
19	Request to foreign regulator	Possible where authenticity of documents cannot be verified	Possible and practically more likely	If no response is received from the foreign authority within 60 business days, refusal is possible
20	Decision of the Center	Registration or refusal of registration	Registration or refusal of registration	The final decisions are the same; the assessment process differs
21	Notification of decision	No later than 2 business days after the decision is made	No later than 2 business days after the decision is made	No differences at the final stage
22	Validity period of the registration certificate	5 years	5 years	The certificate validity period is the same
23	Right to use the device in medical practice	Arises after issuance of the registration certificate	Arises after issuance of the registration certificate	Even under recognition, an Uzbek registration certificate is required
24	Possibility of refusal	Possible in case of inaccurate information, negative conclusions, incomplete remedy of deficiencies, violation of IP rights, etc.	Possible in case of inaccurate information, failure to confirm foreign registration, inconsistency of documents, etc.	Under recognition, the main risk is failure to confirm foreign registration
25	Grounds for refusal related to quality, safety and effectiveness	May be based on laboratory, clinical, inspection and expert results	Usually based on document review, foreign registration and authenticity of documents	Under the general procedure, the evidentiary basis for refusal is broader
26	Role of intellectual property	Existence of rights to IP objects, including trademarks and industrial designs, is checked	The need to confirm rights or absence of infringement also remains	IP review is relevant for both procedures
27	Suitable for new devices without foreign registration	Yes	No	Recognition is impossible without registration by the specified foreign authorities
28	Suitable for imported devices of well-known international manufacturers	Yes, but less favorable in terms of timing	Yes, if FDA / CE / EMA / PMDA / MFDS / MHRA registration exists	Recognition is preferable for international manufacturers
29	Administrative burden	High	Reduced	Recognition reduces the scope of testing and the review period
30	Financial burden	Higher due to testing, examinations, possible inspection and preparation of a full dossier	Lower due to absence of laboratory testing, clinical investigations and inspection	Recognition is more economically advantageous
31	Regulatory risk	Related to test results, clinical data, inspection and technical examination	Related to confirmation of foreign registration and correctness of documents	The risk profile is different
32	Need for local testing in Uzbekistan	Yes, except for statutory cases	No	Recognition excludes local laboratory testing
33	Need for local clinical data	May arise	Does not arise	Clinical investigations are not conducted under recognition
34	Manufacturing site	May be inspected	Not inspected under recognition	Under the general procedure, the manufacturing site is an object of control
35	Applicability to Class I devices	Yes, period — 60 business days; clinical investigations are usually not required	Yes, if the device is registered by a recognized foreign regulator	Recognition is still faster for Class I
36	Applicability to high-risk devices	Yes, but the procedure is the longest and strictest	Yes, if foreign registration by a recognized authority exists	Recognition is especially advantageous for high-risk devices
37	Applicability to devices prequalified by WHO	A separate special procedure is provided — 60 business days	Not identical to recognition of FDA/CE and others	WHO prequalification is an independent preferential category
38	Post-registration obligations	Remain in force: quality, safety, effectiveness, notification of adverse effects, changes and foreign restrictions	Remain in full	After registration, obligations are the same
39	Amendments to documents	Reviewed within periods of up to 50% of the registration periods	For devices registered by recognition, a special approach applies and is expressly excluded from the general 50% rule	After recognition, amendments may require separate assessment
40	Practical recommendation	Choose where there is no recognized foreign registration or where the device is local/new	Choose where valid FDA, CE, EMA, PMDA, MFDS or MHRA registration exists	Where grounds for recognition exist, recognition is usually the preferred route