The main legislative act that establishes the registration requirements and circulation of medical devices is the Law of Turkmenistan “On Drug Provision”. Placing on the market of Turkmenistan and putting into operation of the medical devices is allowed only after state registration.
The competent authority responsible for the registration of medical devices is the State Registration Center for Medicinal Products of the Ministry of Health and Medical Industry of Turkmenistan.
The Applicant (Нolder) of the Мarketing Аuthorization can be both a resident and a non-resident of Turkmenistan. The Applicant must appoint (authorized) a local representative in Turkmenistan for regulatory purposes, which can be Cratia company.
The registration dossier should be submitted in the national format in Russian, Turkmen and (or) English language. The dossier should be submitted in paper form, with one identical copy. Samples of the medical device are submitted upon request of the competent authority.
Instructions for use and the package labeling are submitted and approved in Turkmen and/or Russian, and/or English languages.
The procedure of state registration includes the following steps:
- Submission of an Application and dossier to the competent authority;
- Expert evaluation of documents;
- Inclusion of devices in the State Register;
- Issue of the Marketing Authorization.
The validity of the Marketing Authorization (state registration certificate) is 5 years.
Changes and amendments
Marketing Authorization Holder must submit the Application for variations to the competent authority within 30 days from the date of approval of such changes in the MAH’s or manufacturer’s country, or as soon as MAH became aware of the necessity to implement such changes. The procedure of the assessment and approval of the suggested variations can take from 1 to 3 months from the date of submission of the Application and payment of the state fees.
The renewal procedure
Application for renewal of the registration should be submitted not later than 3 months before the expiry of the registration certificate.
The duration of the renewal procedure is 3-4 months. This period does not include the time required for the Applicant to pay state fees, and to reply to comments/questions of the state experts.
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 Turkmenistan. We have an excellent knowledge of national legislation, necessary experience and resources.