Uzbekistan Medical Device Registration

Understanding Medical Device Registration in Uzbekistan

Updated On: 19/01/2024

Regulatory Authority: Ministry of Health of the Republic of Uzbekistan

The Ministry of Health of the Republic of Uzbekistan is the central healthcare management organ in the country, subordinated to the Cabinet of Ministers. It works with state administration bodies, executive bodies, regions, Tashkent city, and public organizations.

The Ministry follows the Constitution, laws, and international agreements on health care issues. It is responsible for issuing normative legal documents for execution by governmental organs, establishments, organizations, and individuals on Uzbekistan’s territory.

The Ministry, along with the Ministry of Health of the Republic of Karakalpak Stan, health care management bodies in regions and Tashkent city, forms a single system of health care management bodies.

Link for Regulatory Authority: https://www.uzpharm-control.uz/en/pages/state-register-of-medicines-and-medical-products

Local Regulation: Regulations on the procedure of the state registration of medicinal products, medical devices and medical equipment and the issue of a registration certificate

Classification: Classes I, IIa, IIb and III

Listing or Registration Requirements: There are 2 options for state registration of medical devices and medical equipment in Uzbekistan:

• National state registration procedure that stipulates examination of the registration dossier and conducting laboratory tests of the medical device/medical equipment samples and takes about 6-8 months without consideration of time for preparation of responses to the remarks
• Simplified procedure of the state registration of medical devices/medical equipment certified by one of the authorized bodies listed below:
  • Food and Drug Administration, USA;
  • Bodies authorized to issue a European Certificate of Conformity, EU;
  • European Medicines Agency, EU;
  • Pharmaceuticals and Medical Devices Agency, Japan;
  • Ministry of Food and Drug Safety, Republic of Korea;
  • Medicines and Healthcare products Regulatory Agency, United Kingdom

Documents Required:

• Application form with the attached documents:
  • Legalized Power of Attorney from the applicant to the representative
  • General information about a medical device including the information about its manufacturer
  • Copies of registration certificates and/or other certificates issued by the competent authorities of countries, where said medical device is registered or marketed, or justification of their absence
  • Medical device testing methods
  • Passport, manual for operation, instruction for use of a medical device
  • Technical description of a medical device
  • Protocols of laboratory tests, technical tests, preclinical and clinical studies
  • Legalized copies of documents confirming the compliance of the conditions of the manufacture of medical device with the requirements of international standards
  • Information about the absence of infectious agents in a medical device (required for in vitro diagnostics products prepared from biological materials)
  • Stability data within the storage of a medical device (if applicable)
  • Illustrated advertising materials, brochures, catalogues, photo of size not less than 13×18 cm
  • Proposed mock-ups of primary and secondary packaging for the market of Uzbekistan
  • Additional information about quality, efficiency, and safety of a medical device.
• Samples of a medical device and standard samples if applicable in an amount required for conducting tests.

Registration Timeline:

• Depending on the type of product and whether registration with the metrological committee is required medical device registration process can range between 6 to 9 Months
• For Class III devices, this process can take up to a year.

Registration Fee:

License Validity: Registration licenses issued in Uzbekistan are valid for 5 years. The additional metrological certificate is valid for 3 years.

License Renewal: The procedure of the renewal of registration must be initiated within 3 months before expiration of previous registration. The usual renewal procedure lasts for about 6-8 months without considering the time for preparation of responses to the remarks.

Special Labelling Requirements: A registration dossier can be submitted in English with the translation of a part of the documents into Russian. The registration dossier is submitted with a draft instruction for use in Uzbek and Russian.

Additional Comments:

• During the examination of tests, questions and/or remarks may arise. The Applicant shall prepare responses (eliminate defects) within 45 working days.
• The total registration period of the medical device makes up 155 working days from the date of receipt of the application, and until the decision on registration. The deadline to respond to remarks is not included in the total registration period.

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

• Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk