Registration of medical devices in Tajikistan.
Currently, the pharmaceutical sector is one of the priorities for development in Tajikistan. In 2020, the government of Tajikistan issued a resolution “On the State Program for the Development of the Pharmaceutical Industry in the Republic of Tajikistan for 2021-2025”. One of the objectives of the Program is to improve the legal framework of the Republic of Tajikistan in the field of production, registration, import, export and sale of medicines and medical products in accordance with the requirements of international standards. In this article we will talk about how things are with the registration of medical products (including medical devices and medical equipment).
According to the Law of the Republic of Tajikistan “On Medicines and Pharmaceutical Activities”, medical devices are part of the category of medical products:
“Medical products” are products and materials used in medical practice for the diagnosis, treatment, and prevention of diseases. These include materials (dressings, sutures, consumables) and devices (medical, medical equipment, patient care items).
Registration of medical products is carried out in accordance with national requirements and is regulated by the same law (Decree No. 736) as the registration of medicines. It should be noted that in this law, much more attention is paid to drugs rather than to medical products, and some formulations cannot be called unambiguous and understandable enough. Perhaps this is due to the subtleties of translation.
In general, the process of registration of medical products can be represented as follows:
- The applicant submits to the authorized body an application for registration of medical products, a registration file and samples of the medicinal product in the amount of 5 copies.
- The authorized body accepts documents, samples of medical products, conducts an initial examination of the submitted documents for compliance with their established requirements.
- If there are no comments on the documentation submitted for registration, the documents are submitted to the State Unitary Enterprise “Expertise and Testing of Pharmaceutical and Medical Products” or independent experts for expert work. Expert work is carried out within the terms determined by the contract.
- If the documentation meets the established requirements, documents on the specifics and 1 sample of medical products are sent to the department of preclinical and clinical examination and to the standardization department (if necessary, to the Pharmacological and Pharmacopoeia committees – a period of 60 days with a possible extension of 30 days for each examination) for carrying out the main expert assessment.
- Based on the positive decision of the expert commission, a protocol is drawn up and a registration certificate is issued for a period of 5 years.