Registration of Medical Equipment in Uzbekistan

The registration of medical equipment (devices) is a key element of state control in the field of public health protection. The main goal of this procedure is to ensure the safety, quality, and effectiveness of medical devices used in medical practice. In Uzbekistan, the legal framework for registration is established by Resolution of the Cabinet of Ministers No. 213 dated March 23, 2018, which approves the Regulation on the Procedure for State Registration of Medicinal Products, Medical Devices, and Medical Equipment.

The regulatory basis consists of:

• The Law of the Republic of Uzbekistan “On Medicines and Pharmaceutical Activities”;
• Presidential Resolutions Nos. PP–3052, PP–3489, and PP–3532;
• Cabinet of Ministers Resolution No. 213 of March 23, 2018.

These acts aim to harmonize the national system with international standards such as GMP, GCP, and ISO.

Competent Authority

The key authority responsible for registration is the State Institution “Center for Safety of Pharmaceutical Products”, under the Ministry of Health of the Republic of Uzbekistan. The Center performs the following functions:

• Examination of documentation;
• Assessment of quality, safety, and efficacy;
• Maintenance of the State Register;
• Issuance of the Certificate of Registration.

Scope and Objects of Registration

The following are subject to registration:

• Medical devices and equipment (apparatuses, instruments, devices);
• Newly developed or modified types of already registered products;
• Imported devices intended for medical use.

Exemptions: Registration is not required for samples imported for:

• Scientific research;
• Clinical trials;
• Exhibitions, fairs, or humanitarian aid.

Registration Procedure

Stage 1. Application Submission

The applicant (manufacturer or authorized representative) submits:

• An application in the prescribed form;
• An electronic package of registration documents signed with an electronic digital signature (EDS);
• Samples of medical equipment for testing;
• Documents confirming intellectual property rights (patents, trademarks).

Stage 2. Preliminary Examination

The Center verifies the completeness and accuracy of the information, compliance with regulatory documentation, and the existence of intellectual property rights.

Stage 3. Laboratory Tests and Expert Evaluation

This stage includes:

• Technical, biological, and toxicological tests;
• Assessment of clinical data and labeling;
• Verification of compliance with GMP and ISO 13485 standards.

Stage 4. Expert Committees

Expert assessments are conducted by:

• The Pharmacopoeia Committee;
• The Committee on Pharmacology;
• The Committee on New Medical Equipment;
• The Committee on Control of Narcotic Substances (if applicable).

Stage 5. Decision Making

Based on the expert conclusions, the Expert Council of the Ministry of Health makes a decision on registration and issues a Certificate of State Registration.

Registration Terms and Fees

• For domestic manufacturers — registration is indefinite;
• For foreign manufacturers — valid for 5 years;
• Registration fee:
  • 10 base calculation units (BCU) — for application review;
  • 2 BCU — for issuance of the registration certificate.

Application Review Deadlines

Category of Devices	Processing Time
Recognition by WHO or foreign regulators	15 days
Pharmacopoeial plant raw materials, bandages, and similar products	120 days
Other medical devices and equipment	155 days
Correction of deficiencies	up to 45 additional days

Grounds for Refusal of Registration

Registration may be refused if:

• The submitted materials fail to meet safety requirements;
• Efficacy has not been proven;
• Intellectual property rights are violated;
• Test results are unsatisfactory.

International Recognition

The Regulation provides for accelerated registration of devices already certified or registered in countries and organizations recognized by Uzbekistan (such as the EU, WHO, FDA, etc.), which significantly simplifies the import of innovative medical equipment.

The registration of medical equipment in Uzbekistan is a systematic and scientifically grounded process aimed at ensuring the safety and quality of medical devices. Resolution No. 213 established a modern regulatory framework aligned with international standards and greatly enhanced the transparency of market access for medical technologies.

Algorithm of Medical Equipment Registration

Stage	Description of Procedure	Participants	Documents / Requirements	Timeline
1. Preparation of documents	Determination of the product type and its classification as “medical equipment.”	Manufacturer or authorized representative	Product passport, technical documentation, instructions, ISO/GMP certificates, test data.	Before application submission
2. Application submission	The application is submitted to the State Institution “Center for Safety of Pharmaceutical Products.”	Applicant	Application form, electronic package of registration documents, EDS.	Any working day
3. Submission of samples	Transfer of samples for laboratory and technical testing.	Applicant → Center	Samples, standard reference materials, reagents.	Together with application
4. Preliminary examination	Verification of documentation completeness, IP rights, and correct classification.	Registration Department of the Center	Registration dossier review, trademark rights verification.	Up to 15 days
5. Laboratory tests	Conducting technical, toxicological, and biological tests.	Center laboratories	Test reports, compliance with ISO 13485 and GMP standards.	60–120 days
6. Expert committees	Expert review of documentation and laboratory findings.	Committees on Pharmacopoeia, Pharmacology, New Medical Equipment	Protocols, expert conclusions.	Parallel with stage 5
7. Expert Council decision	Review of final materials and decision-making.	Expert Council of MoH	Recommendation: “Register / Refuse.”	Within 10 days
8. Certificate issuance	Issuance or dispatch of the Certificate of State Registration.	Center → Applicant	Certificate of registration, entry into the State Register.	1 working day
9. Validity period	For local manufacturers — indefinite; for foreign — 5 years.	Ministry of Health	Maintenance of dossier, compliance monitoring.	Ongoing
10. Amendments and renewal	In case of changes to design, labeling, or production — submission of supplements and re-evaluation.	Applicant → Center	Supplementary application, new test protocols.	Within 60 days