Uzbekistan Medical Device Registration CIS National Certification

Many medical device manufacturers are unfamiliar with the registration procedures for medical devices exported to Uzbekistan. The following is a detailed introduction.
Decree of the Cabinet of Ministers of the Republic of Uzbekistan on the approval of the state registration procedure for medicines, medical products and medical devices, as well as the rules for issuing registration certificates.

Basic Definition of Uzbekistan Medical Device Registration:

1. Medicinal products

2. Medicinal substances

3. Substances or mixtures with specific dosage forms, with pharmacological activity and safety confirmed in preclinical studies, which are subjects of clinical research;

4. Medicinal herbal raw materials: plants or plant parts containing bioactive substances for pharmaceutical production;

The Center for Specialized Technical Regulation and Standardization of Medicines, Medical Devices and Equipment under the Ministry of Health of Uzbekistan (hereinafter referred to as the National Center) serves as the executive body of the national pharmaceutical regulatory authority. It is responsible for state registration, quality control, standardization and certification of medicines and medical devices.

Scope of State Registration in the Republic of Uzbekistan:

1. Medicines;

2. New combination drugs registered in Uzbekistan;

3. Generic drugs previously registered in Uzbekistan but produced in different dosage forms, dosages or by other manufacturers;

4. Medical devices;

5. Medical supplies;

6. Drugs dispensed by pharmacy prescriptions, radioactive drugs, and non-commercial drugs produced locally or imported from abroad are exempt from registration.

7. Different drugs with the same trade name, or identical drugs with the same ingredients under different trade names from one manufacturer shall not be registered.

8. Registration certificates will be issued with a validity period of 5 years upon completion of review.

9. The registration certificate is an official document proving state approval and legal use of medicinal products and medical devices in medical practice.

10. The registration and certification of foreign medicines and medical devices shall be implemented in accordance with these regulations.

11. The National Center shall be responsible for the confidentiality control of classified information in registration documents.

The validity period of registration certificates may be extended upon application. Renewal applications must be submitted to the National Center three months before expiration. The renewal process shall follow the same rules as initial registration.