Turkmenistan, a Central Asian nation with a growing healthcare sector, has established a regulatory framework for the registration and circulation of medical devices. As a regulatory affairs manager, understanding the key aspects of this process is crucial for successfully introducing medical devices into the Turkmenistan market. Let us review the registration requirements, procedures, and important considerations for medical device registration in Turkmenistan.
Legislative Framework
The primary legislative act governing the registration and circulation of medical devices in Turkmenistan is the Law of Medicines Supply. This law establishes the legal basis for the registration, manufacturing, import, and distribution of medical devices in the country.
Competent Authority
The Center for Registration and State Quality Control of Medicinal Products under the Ministry of Health and Medical Industry of Turkmenistan is the authorized body responsible for the registration of medical devices. This center oversees the evaluation, approval, and monitoring of medical devices in the country.
Applicant Eligibility
Both residents and non-residents of Turkmenistan can apply for medical device registration as the Marketing Authorization Holder (MAH). However, non-resident applicants must appoint a local representative in Turkmenistan who can act on their behalf under a Power of Attorney.
Registration Dossier Requirements for Medical Devices
The registration dossier for medical devices in Turkmenistan must be submitted in a national format, following the approved list of documents. The dossier can be prepared in Russian, Turkmen, or English and must be submitted in two copies: the original and an identical copy. The list of documents required for medical device registration includes:
- Application for registration or re-registration of medical devices or medical equipment in the approved format.
- Document confirming the state registration of the manufacturing enterprise as a legal entity, including details such as the organization’s name, registration number, type of activity, legal address, form of ownership, and information about the head of the manufacturing enterprise.
- Documents characterizing the conditions of production and confirming compliance of the medical device with the requirements of national or international regulatory documents, such as:
- Certificate/declaration of conformity of production conditions and product quality requirements
- Certificate of compliance of production conditions with the requirements of ISO standards
- National certificates for the quality control (management) system of medical device production
- Documents confirming the compliance of the medical device with the requirements of technical specifications or standards, such as:
- Free sale certificate
- Other documents issued by the authority supervising the circulation of medical devices on the market (registration certificate)
- Any other certificates indicating that the product is used in other countries and meets the requirements for efficacy and safety
- Regulatory document and accompanying documents confirming the compliance of the medical device with its requirements or technical specifications, or the requirements of toxicity and medical testing standards (test report for this type of product).
- Stability test report (for consumables with a shelf life, such as solutions, reagent kits, test systems).
- Instructions for use, containing sufficient information for effective and safe use by qualified personnel in the medical institutions where the registered product is intended to be supplied.
- Instructions for use intended for the country where the medical device is manufactured (in Russian/English).
- Document confirming the trade name of the medical device (patent, if available).
- Promotional materials and images of the medical device.
In addition to the above documents, samples of the medical device may be requested by the State Center for Registration of Medicines. Instructions for use and packaging labels must be submitted and approved in Turkmen, Russian, English, and other languages.
Medical Device Registration Procedure in Turkmenistan
The state registration process for medical devices in Turkmenistan involves the following steps:
- Submitting an application and dossier in accordance with the established procedure
- Reviewing the applicant’s documents by the competent authority
- Adding the approved products to the State Register of Medical Devices
- Issuance of the Registration Certificate
The Registration Certificate is valid for 5 years from the date of issuance.
Key Points
- A comprehensive set of documents is required for state registration of medical devices in Turkmenistan, covering various aspects such as legal status of the manufacturer, compliance with national and international standards, product specifications, stability data, and instructions for use.
- Documents must be submitted as originals or certified/notarized copies in Russian, Turkmen, and/or English.
- The registration process involves submitting an application and dossier, review by the competent authority, inclusion in the State Register, and issuance of the Registration Certificate, which is valid for 5 years.
- Providing all the necessary documents in the required format is crucial for a smooth registration process.
Post-Registration Variations
If any changes or additions to the registered medical device or its dossier are required, the applicant must submit an Application and relevant documents to the authorized body within 30 calendar days of the manufacturer’s approval of such changes.
The duration of the change approval process ranges from 1 to 3 months, depending on the complexity of the changes.
Re-Registration of Medical Devices in Turkmenistan
To maintain the registration status of a medical device, the applicant must apply for re-registration no later than 3 months before the expiration of the current Registration Certificate.
The re-registration process typically takes 3 to 4 months and, if successful, results in the issuance of a new Registration Certificate valid for the next 5 years.
Time to Register Medical Devices in Turkmenistan
The medical device registration process in Turkmenistan requires a thorough understanding of the legislative framework, dossier requirements, and procedural steps. By carefully preparing the registration dossier, adhering to the established timelines, and maintaining open communication with the competent authority, regulatory affairs managers can successfully register their medical devices in Turkmenistan.
To streamline the registration process and ensure compliance with local regulations, consider partnering with experienced consultants or local representatives who have in-depth knowledge.
Delta Medical provides regulatory support for medical device and pharmaceutical registrations in Turkmenistan and Central Asia. Our experts can assist with product registration, licensing, compliance, and all documentation needed to meet local requirements. Contact Delta Medical today to learn more about bringing your medical devices to new markets across the region.
