Medical devices, medical equipment and patient care items are subject to mandatory state registration in Tajikistan. The main legislative act is the Law of the Republic of Tajikistan “On Medicines and Pharmaceutical Activity”. The requirements for the registration procedure are stipulated by the Order of the Ministry of Health and Social Protection of the Population of the Republic of Tajikistan No. 736 dated August 21, 2015 “On Approval of the Procedure for State Registration of Medicines and Medical Goods in the Republic of Tajikistan”.
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. Cratia can represent the interests of the MAH acting as an attorney.
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. 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.
Instructions for use of the medical device (user’s manual) should be submitted in Russian or Tajik language.
The registration procedure takes from 2 to 6 months.
The registration certificate is issued for 5 years.
Changes and variations
During the validity of the Marketing Authorization, the Applicant (MAH) must inform the competent authority of any changes. The types of changes are not described in the legislation, the requirements for the content of the documentation should be discussed with the competent authority.
Renewal procedure
Application for renewal should be submitted not later than 3 months before the expiry of the registration certificate. The renewal procedure and its duration are almost identical to the initial registration, as well as the content of the registration dossier.
As a result of the renewal procedure, a Marketing Authorization (registration certificate) is issued for the next 5 years.
Cratia provides professional services of state registration of medical devices in Tajikistan. We have an excellent knowledge of national legislation, necessary experience and resources.
To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.