New registration, renewal and variations

Cratia provides professional medical device registration (market authorization, conformity assessment, notification) services in 12 countries and the Eurasian Economic Union (EAEU):

Azerbaijan Georgia Moldova Turkmenistan
Armenia Kazakhstan Mongolia Uzbekistan
Belarus Kyrgyzstan Tajikistan Ukraine

All in-country activities (submissions, communication with competent authorities etc.) are performed out by our local employees with high qualifications and experience, knowledge of national legislation and language. All activities are coordinated by our central office, whose experts communicate with the Customer, verify and prepare documentation, control the quality and timelines.

The Head office is located in Ukraine, the country with the most developed and high regulatory requirements. In 2013, Ukraine adopted Technical Regulations for medical devices based on Directives 93/42/EEC, 98/79/EC and 90/385/EEC. We have successfully applied the many years of experience and knowledge gained on the national market to scale services in other countries. Our experts have deep knowledge of the national legislation of each country, specific requirements for registration materials and approval procedures, use professional terminology and monitor all changes.

For more than 10 years for all our customers we distribute a free newsletters on the major regulatory changes in the region. We conduct seminars and webinars, write analytical articles and advice on various issues.

 

National requirements in brief:

Azerbaijan  State registration of medical devices is not carried out. For the import of medical devices and medical equipment, it is necessary to receive a confirmation letter regarding the classification of such a product, and then obtain a hygiene certificate from the competent authority.
Armenia Armenia is a member of the EAEU. Registration of medical equipment and medical devices is carried out in accordance with the EAEU registration requirements.
Belarus Belarus is a member of the EAEU. Registration is carried out according to the national procedure, or according to the unified rules of the EAEU. National registration does not require the designation of an Authorized Representative. The language of labeling and instructions for use (user manuals) is Russian or Belarusian. Inspection is mandatory at the first registration of the site.
Georgia The legislation of Georgia is actively harmonized with the EU. An Association Agreement with the EU was signed in 2014. The registration of medical devices in Georgia is not applicable, with the exception of dental materials and diagnostic tools (test systems, allergens, reagents) which undergo a procedure similar to the registration of medicinal products. The designation of an Authorized Representative is not required. Production inspection is not carried out.
Kazakhstan Kazakhstan is a member of the EAEU. Registration is carried out according to the national procedure, or according to the EAEU unified rules. The designation of an Authorized Representative is required for a non-resident manufacturer. Packaging labeling, instructions for use (user manual) are submitted and approved in Russian and Kazakh. Inspection is mandatory at the first registration of the site.
Kyrgyzstan Kyrgyzstan is a member of the EAEU. Registration is carried out according to the national procedure, or according to the unified rules of the EAEU. The designation of an Authorized Representative is required for a non-resident manufacturer. Packaging labeling, instructions for use (user manual) are submitted and approved in Russian and/or Kyrgyz. Inspection is mandatory at the first registration of the site.
Moldova The legislation of Moldova is actively harmonized with the EU, in 2014 the Agreement on the Association of Moldova and the EU was signed. The designation of an Authorized Representative is required for a non-resident manufacturer. Medical devices admitted to the EU market undergo a simplified procedure for market access by notification. Other medical devices undergo a procedure similar to the procedures for assessing the conformity of the EU Directives. Labeling of the medical device, instructions for use (user manual) must be provided to the user and patient in Romanian. Inspection is not required for notification procedures, but may be provided for by a conformity assessment procedure for other medical devices.
Mongolia  Medical devices and medical equipment are not subject to registration in Mongolia. Diagnostic medical products (diagnostic kits) are subject to registration by a procedure similar to that for medicinal products.
Tajikistan Medical devices, medical equipment and patient-care items are subject to mandatory state registration in Tajikistan. The designation of an Authorized Representative is not required. The packaging labeling and instructions for use are submitted to the competent authority, undergo an expert evaluation and are approved in Russian and/or Tajik. Production inspection is not carried out.
Turkmenistan Medical devices are subject to state registration. The designation of an Authorized Representative is not required. Instructions for use and labeling of the packaging are submitted and approved in Turkmen and/or Russian, and/or English, and other languages. Production inspection is not carried out.
Uzbekistan  Medical devices are subject to state registration. The designation of an Authorized Representative is not required. Instructions for use (user manual) are submitted and approved in the Uzbek and Russian languages. Production inspection is not carried out.
Ukraine The legislation of Ukraine is actively harmonized with the EU. In 2014, the Association Agreement with the EU was signed. In 2013 the Technical Regulations for medical devices were adopted based on Directives 93/42/EEC, 98/79/EC and 90/385/EEC. The designation of an Authorized Representative is required for a non-resident manufacturer. Conformity assessment procedures are similar to those provided for in the European Directives. For some medical devices that have access to the EU market, a simplified recognition procedure may be applied. Instructions and labeling are submitted and examined in Ukrainian. Inspection is not required for the recognition procedure and low risk classes, but may be provided for in conformity assessment procedure for other medical devices.
Eurasian Economic Union The EAEU includes 5 countries: Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia. Registration of medical devices according to the unified rules of the Union will become mandatory from January 1, 2022. In the transition period until December 31, 2021, the registration of medical devices may be carried out according to the national procedure, or according to the EAEU unified rules at the choice of the manufacturer of medical devices. For a non-resident manufacturer, the designation of an Authorized Representative is required. The registration procedure allows to obtain authorization in one or more EAEU countries. For registration it is necessary to conduct preliminary technical and, if necessary, metrological and clinical tests in the territory and in accordance with the rules of the EAEU, in authorized organizations. Inspection is necessary for medical devices of classes IIa (manufactured in sterile form), IIb and III.

Cratia Ltd. performs expert work on the state registration of medical devices in Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Uzbekistan, Ukraine and the Eurasian Economic Union. We are well versed in the national legislation, we have the necessary experience and resources to carry out the work.

To start cooperation or get advice, please contact us by phone: +38 044 361-48-28, +38 044 221-71-29, by e-mail: info@cratia.ua, or visit our office

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