Registration of medical devices Turkmenistan

The purpose of the state registration of medicinal products and medical devices is to determine their compliance with the requirements established by this Law and other laws and regulations of Turkmenistan, as well as to prevent the import into Turkmenistan, production, and circulation of medicinal products and medical devices that may pose a danger to human life and health, as well as to human genetics.

- Russia
- Kyrgyzstan
- Georgia
- Kazakhstan
- Belarus
- Tajikistan
- EAEU

What types of medical devices are not subject to registration?

According to Law of Turkmenistan No. 319-V “On Medical Supplies” dated 12 January 2016, the state registration is carried out by the authorised body in accordance with the Regulations on the state registration of medicinal products and medical devices approved by the Ministry of Health and Medical Industry of Turkmenistan.

The following medicinal products and medical devices imported into Turkmenistan are not subject to state registration:

samples (samples of pharmaceutical substances) intended for state registration in an amount not exceeding ten packages;

those intended for preclinical and clinical studies;

those which are exhibition samples not intended for sale or use in the future;

those intended for personal use.

Registration stages:

Preparation of the registration dossier, collection of all necessary documents;

Preliminary analysis of the registration dossier, evaluation of the collected package of documents and making adjustments;

Import of samples of medical devices;

Filing the application for the procedure, filing the application with the state body;

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;

Making payment according to the invoice;

Specialised expert examination, including analytical testing;

Issuance of the registration certificate, with the placement of information in the State Register of Turkmenistan, and the issuance of the paper registration certificate.

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