Registration of medical devices Tajikistan
Medicinal products and medical goods are manufactured, sold and used within the territory of the Republic of Tajikistan after their state registration according to the procedure determined by the Ministry of Health of the Republic of Tajikistan.
01
What types of medical devices need to be registered?
According to Decree of the Ministry of Health and Social Protection of the Population of the Republic of Tajikistan No. 736 “On Approval of the Procedure for State Registration of Medicines and Medical Products in the Republic of Tajikistan” dated 21 August 2015,
the following products are subject to state registration:
- New medicinal products
- New combinations of previously registered medicinal products
- Medicinal products previously registered, but produced in other dosage forms, with a new dosage, produced using a different excipient composition
- Reproduced (generic) medicinal products
- Generic medicinal products (generics)
- Synthetic detergents
- Cosmetics having therapeutic and prophylactic properties
- Therapeutic and prophylactic foods
- Dietary supplements
- Disinfectants
- Baby food
- Medical goods and diagnostic tools
02
Registration stages:
01
Preparation of the registration dossier, collection of all necessary documents
02
Preliminary analysis of the registration dossier, evaluation of the collected package of documents and making adjustments
03
Import of samples of medical devices
04
Filing the application for the procedure, filing the application with the state body
05
Primary expert examination of the documents, analysis of the documents of the registration dossier with the issuance of an invoice for the expert examination upon completion of the stage
06
Specialised expert examination, including analytical testing
07
Making payment according to the invoice
08
Issuance of the registration certificate, with the placement of information in the State Register of the Republic of Tajikistan, and the issuance of the paper registration certificate
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