Registration of Medical Devices in Uzbekistan

The registration of medical devices is a key element of the state system ensuring the safety of medical products and protecting public health. It serves as a mechanism for admitting to the domestic market only those devices that meet established requirements of quality, efficacy, and safety. In Uzbekistan, this procedure is governed by Resolution No. 213, developed in accordance with the Law “On Medicines and Pharmaceutical Activities” and Presidential Decrees No. PP-3489 and No. PP-3532, which aim to develop the pharmaceutical industry and improve the regulation of medical product circulation.

The main executive body for registration is the State Institution “Center for Pharmaceutical Product Safety” under the Ministry of Health. The Center receives applications, conducts document reviews, and organizes laboratory tests.

Other participating bodies include:

• Pharmacopoeial Committee – evaluation of chemical-pharmaceutical and biological characteristics;
• Pharmacological Committee – assessment of pharmacological, toxicological, and clinical data;
• Committee for New Medical Equipment – verification of technical and operational properties of devices;
• Pharmaceutical Inspection (Pharminspection) – inspection of manufacturing conditions for compliance with GMP standards;
• Committee on Drug Control – in cases involving narcotic, psychotropic, or precursor components.

Objects and Conditions of Registration

Registration is required for:

• all medical devices and equipment intended for diagnosis, prevention, or treatment of diseases;
• new combinations of previously registered medicines;
• medical devices manufactured by a different producer or in a new dosage or release form.

Exempt from registration are products intended solely for scientific research, exhibitions, or humanitarian aid.

Registration Procedure and Stages

Stage	Content	Duration
1. Application submission	Submission through the electronic system of the Center; electronic copies of registration documents, product samples, and proof of fee payment must be attached.	—
2. Preliminary examination	Verification of completeness of documents and initial assessment of compliance with intellectual property rights (IPR).	up to 15 days
3. Laboratory testing	Chemical-technical tests and safety analysis.	15–120 days depending on product class
4. Expert committee review	Comprehensive evaluation and recommendations for approval or rejection.	up to 155 days
5. Certificate issuance	Upon positive decision, the Center issues a Registration Certificate confirming the product’s authorization for medical use.	1 working day

The total review period does not exceed 155 days, excluding time for addressing remarks or conducting clinical trials.

Documents and Requirements

The applicant must submit:

• an application in the approved form;
• an electronic registration dossier;
• product samples;
• documents confirming intellectual property rights;
• clinical trial data (if required);
• proof of GMP compliance for manufacturing facilities.

It is prohibited to demand documents not specified in the regulation.

Financial Conditions

A state fee of 10 BCV (base calculation value) is charged for the review of the application and 2 BCV for issuance of the certificate. For foreign manufacturers, the certificate is valid for 5 years; for domestic manufacturers, it is perpetual.

Expertise and Control

The expert evaluation of medical devices assesses:

• quality and technical characteristics;
• compliance with national and international standards;
• safety for human health;
• observance of intellectual property rights;
• manufacturing conditions and quality system (GMP).

Results are formalized in an expert opinion, which forms the basis for the registration decision.

Recognition of Foreign Registrations

The regulation allows simplified registration for devices already approved in countries with high regulatory standards and/or recognized by the WHO. Such devices may be registered without repeated clinical trials, provided certification and quality confirmation are submitted.

Scientific and Practical Significance

The registration process ensures:

• state control over product quality and safety;
• harmonization of national standards with international norms (GMP, GCP, ISO);
• development of Uzbekistan’s pharmaceutical industry;
• increased public confidence in the healthcare system.

Registration of medical devices in Uzbekistan is a complex yet transparent mechanism for market authorization. It is based on principles of scientific justification, independent expertise, and international recognition of quality standards. Further system development requires digitalization, reduction of review timelines, and integration with international databases.

Step-by-Step Algorithm of Medical Device Registration

№	Stage	Responsible Body	Description	Duration	Result / Document
1	Preparation of dossier	Applicant	Formation of a registration dossier including technical documentation, manuals, GMP/ISO certificates, and safety and efficacy data.	—	Complete dossier
2	Submission of application	Applicant → Center for Pharmaceutical Product Safety (CPPS)	Electronic submission through CPPS system with attachments and fee payment (10 BCV).	—	Electronic receipt
3	Preliminary review	CPPS Registration Department	Verification of dossier completeness and IPR data.	up to 15 days	Decision to proceed to expertise
4	Contract and sample transfer	CPPS ↔ Applicant	Signing of contract for expertise; transfer of samples to laboratories.	up to 3 days	Payment and transfer confirmation
5	Laboratory research	CPPS laboratories	Conducting chemical, biological, and toxicological tests; evaluation of compliance with standards.	15–120 days	Laboratory test report
6	Document expertise	Pharmacopoeial, Pharmacological, and New Equipment Committees	Analysis of dossier for quality, safety, efficacy, regulatory compliance, and IPR verification.	up to 155 days	Expert conclusion
7	Expert Council meeting	Ministry of Health	Review of committee conclusions and decision on registration or refusal.	within 5 days after expertise	Registration decision
8	Certificate issuance	CPPS	Preparation and issuance (or electronic dispatch) of State Registration Certificate.	1 working day	Registration Certificate
9	Entry into State Register	CPPS / Ministry of Health	Entry of data into the State Register of authorized medical devices.	immediately after registration	Publication in the Register
10	Post-registration control	CPPS / Pharminspection	Ongoing monitoring of quality, complaints, pharmacovigilance, and changes in composition or technology.	continuous	Pharmacovigilance report

Classification of Medical Devices by Risk Level and Registration Duration

Class	Risk Characteristics	Example Devices	Main Requirements / Scope of Expertise	Registration Time (working days)
Class I (low risk)	Minimal impact on human body; short-term or external use.	Bandages, syringes, thermometers, gauze, disposable gloves.	Review of technical documentation, laboratory tests (if required), ISO 13485 compliance.	up to 15 days (simplified)
Class II-a (moderate risk)	Limited impact or short-term internal use.	Infusion systems, catheters, contact lenses, dental materials.	Dossier expertise, lab tests, compliance with technical regulations.	up to 60 days
Class II-b (increased risk)	Longer or invasive use; clinical data required.	Diagnostic reagents, endoscopes, physiotherapy devices, medium-complex implants.	Clinical trials (≤ 90 days), toxicological and pharmacological studies.	up to 120 days
Class III (high risk)	High impact on vital functions; invasive or implantable.	Pacemakers, artificial heart valves, orthopedic implants, artificial organs.	Full cycle of expertise: lab, toxicological, clinical, GMP certification, IPR review.	up to 155 days

Additional Provisions

• Devices approved by the WHO or registered in countries with high regulatory reliability may undergo simplified registration without clinical trials, upon confirmation of GMP and ISO certificates.
• Certificates for domestic manufacturers are permanent, while for foreign manufacturers they are valid for 5 years.
• All devices are entered into the State Register of Medical Devices, serving as official authorization for circulation in Uzbekistan.