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Tajikistan Medical Device Registration

Tajikistan Medical Device Regulation

Navigating Medical Device Registration & Post-Market Surveillance in Tajikistan

Updated on: 22/01/2024

Overview on Medical Registration:

In Tajikistan, medical devices, equipment, and patient care items are required to be registered under the Law of the Republic of Tajikistan “On Medicines and Pharmaceutical Activity”. The registration process is outlined in the Order of the Ministry of Health and Social Protection of the Population of the Republic of Tajikistan No. 736 dated August 21, 2015. The registration is performed in the name of the Applicant (Marketing Authorization Holder), who can be a legal entity, resident, or non-resident of the Republic of Tajikistan. The registration dossier should include copies of protocols, reports, certificates of quality, certificates of origin, product photos, and a regulatory document. The user’s manual should also be submitted in Russian or Tajik. The registration process takes 2 to 6 months, and the certificate is issued for 5 years.

Regulatory Authority: Ministry of Health and Social protection of the health of the population of Republic of Tajikistan

 Ministry of Health and Social Protection of the Republic of Tajikistan is the central executive body of the Republic of Tajikistan responsible for the development and implementation of a unified state policy and regulation of legal norms in health and social protection sector of the population.The Ministry, relevant subdivisions of local executive authorities and the ministries (departments) of the republic form a unified system of state administration, ensuring the implementation of a unified state health and social protection sector policy.

Standards, provisions, norms, and regulations developed and approved by the Ministry in health and social protection sector in accordance with the established procedures have a binding effect on all ministries and departments of the Republic of Tajikistan, local executive authorities, enterprises, institutions, and organizations, regardless of the form of ownership and departmental affiliation, as well as individuals.

 Link for Regulatory Authority: https://moh.tj/en/

Local Regulation: Order No. 736 – On Approval of the Procedure for state registration of medicines and medical goods in the republic of Tajikistan

Classification:

  • Class I
  • Class II
  • Class III

Listing or Registration Requirements:

  • Registration is performed in the name of the Applicant (Marketing Authorization Holder – MAH). The MAH can be a legal entity, resident, or a non-resident of the Republic of Tajikistan.
  • Registration procedure requires submission of the Application and set of documents, in some cases import and submission of the samples can be also required. The registration dossier is submitted in translation into Russian or Tajik language.

Documents Required for Registration:

The dossier should contain copies of protocols and reports relating to technical, hygienic (preclinical) and clinical data, certificates of quality, certificate of origin of the medical device, product photos, as well as a specific regulatory document drawn up in accordance with national requirements. 

  • Application form for state registration of a medical device.
  • Certificate of state registration of the manufacturer (if the applicant is not the manufacturer).
  • Certificate of free sale or equivalent document issued by the competent authority of the country of manufacture.
  • Copy of the product’s specifications.
  • Instructions for use and labelling in Tajik, Russian, or English.
  • Preclinical and/or clinical study reports, if applicable based on the device’s risk classification.
  • Other documents as specified in the regulations.

Registration Timeline:2 to 6 months

License Validity: 5 years

License Renewal: Renewal of the registration certificate is required3 months before its expiration date. The renewal process involves submitting an updated dossier and payment of applicable fees.

Special Labelling Requirements:Instructions for use of the medical device (user’s manual) should be submitted in Russian or Tajik language.

Post Market Surveillance:

Tajikistan’s regulatory framework for medical devices, including post-market surveillance (PMS), is still under development. However, there are some existing regulations and practices relevant to monitoring the safety and performance of medical devices after they are placed on the market.

The State Supervision Service for Health Care and Social Protection of the Population of the Republic of Tajikistan (SSSHSPP) is responsible for the registration and post-market surveillance of medical devices.

PMS Activities

  • Adverse event reporting: Healthcare professionals and manufacturers are required to report adverse events associated with medical devices to the SSSHSPP. However, the reporting system is not well established, and underreporting is likely.
  • Field inspections: The SSSHSPP can conduct inspections of healthcare facilities and distributors to ensure compliance with medical device regulations. These inspections may also identify potential safety issues with devices.
  • Import controls: The Agency for Standardization, Metrology, Certification and Trade Inspection can detain or reject imports of medical devices that do not meet Tajikistani standards.

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: [email protected]