About Us
In accordance with Order No. 360 of the Minister of Health of the Republic of Uzbekistan dated November 25, 2024, a Certification Body for Quality Management Systems was established within the State Institution "Center for Pharmaceutical Product Safety" under the Ministry of Health of the Republic of Uzbekistan. The activities of the body are carried out in accordance with the Regulation on the Procedure for Certification of Management Systems, approved by Annex No. 4 to Resolution No. 502 of the Cabinet of Ministers of the Republic of Uzbekistan dated August 14, 2024, "On Approval of Regulations on the Procedure for State Registration of Products and Conformity Assessment."

Our mission is to ensure independent and impartial evaluation of quality management systems to enhance the safety and effectiveness of medical devices. The body is headed by Shodibekov Kozimbek Bakhtiyorovich, under whose leadership processes are developed to ensure transparency and impartiality in certification activities.

Staff Composition
The staff of the certification body consists of highly qualified specialists with extensive experience in the field of medical devices and medical technologies. All employees hold international certificates in accordance with the ISO 13485 standard and have been certified in compliance with Resolution No. 177 of the Cabinet of Ministers of the Republic of Uzbekistan dated March 30, 2024, "On Additional Measures to Improve Standardization Activities." pecialists are authorized by the state to conduct inspections in the field of certification, confirming their competence and ability to provide an objective assessment of quality management systems.

Certification and Audit Processes
The processes for certification audits, surveillance audits, and recertification are developed in accordance with the requirements of ISO/IEC 17021-1 and include the following stages:

• Development of an audit program and plan, taking into account the scope and purpose of certification.
• Analysis of quality management system documentation.
• On-site audit to assess compliance with the ISO 13485 standard.
• Identification and resolution of nonconformities.
• Decision-making on the issuance of a certificate.

Surveillance audits are planned to be conducted annually, and recertification every three years. All procedures are approved within the framework of 15 internal documents and will be available for review after the completion of accreditation.

Decision-Making on Certificates
Decisions on the issuance, confirmation, renewal, suspension, cancellation, as well as expansion or reduction of the scope of certificates, are made by an independent commission based on audit results. The decision-making process is regulated by internal procedures and ensures objectivity and impartiality. Detailed information will be published after the completion of accreditation.

Types of Management Systems and Certification Schemes
The certification body conducts certification of quality management systems for medical devices in accordance with the ISO 13485 standard. Certification is carried out according to a scheme that complies with international requirements, including IAF MD 9. As the body develops, the list of certified standards may be expanded.

Publicly Available Information in Accordance with ISO/IEC 17021-1
The certification body provides the following information in open access, as required by clause 8.1.1 of the international standard ISO/IEC 17021-1 and Resolution No. 502 of the Cabinet of Ministers of the Republic of Uzbekistan dated August 14, 2024:

• Audit processes: including planning, conducting, reporting, and follow-up actions.
• Decision-making processes: issuance, refusal to issue, confirmation, renewal, suspension, or cancellation of a certificate, as well as expansion or reduction of the certification scope.
• Types of management systems audited: currently, quality management systems under ISO 13485; other certification schemes may be introduced in the future.
• Use of the body’s name and logo: conditions and restrictions for using the certification mark.
• Processes for handling requests: including the procedure for submitting information requests, complaints, and appeals.
• Impartiality policy: measures taken to ensure the objectivity of certification.

Submission of Complaints and Appeals
Interested parties may submit complaints, claims, or appeals through the feedback form on the via email at farmkomitet@ssv.uz All requests are reviewed by an independent commission within 30 calendar days. The review procedure is approved and will be available for review after the completion of accreditation.

Impartiality Policy
The certification body adheres to a strict impartiality policy that eliminates conflicts of interest. Key measures include:

• Prohibition on providing consulting services to certified organizations.
• Establishment of an independent impartiality committee.
• Regular analysis of risks related to impartiality.

The policy is approved within the framework of internal procedures and will be published after the completion of accreditation.

Contact Information
Address: 100002, Tashkent, Ozod Street (formerly Usmonkhojayev), K.Umarov Passage, 16.
Phone: +998 71 203-01-01.
Email: farmkomitet@ssv.uz
Website: https://www.uzpharm-control.uz.

Information is provided upon written request, through the feedback form on the website, or in person at the office.

Note: The information on this page is valid as of May 8, 2025. The data will be updated as the accreditation process progresses.