Cratia provides professional medical device registration (market authorization, conformity assessment, notification) services in 12 countries and the Eurasian Economic Union (EAEU):
The designation of an Authorized Representative is an obligatory requirement for the registration (conformity assessment) of medical devices in Kazakhstan, Kyrgyzstan, Moldova, Ukraine and for the registration of medical devices according to the unified rules of the EAEU.
An Authorized Representative is a link between the national market (consumers, conformity assessment bodies and competent authorities, importers and distributors, market surveillance authorities, etc.) and the manufacturer, performs post-marketing supervision. The name and address of the Authorized Representative must be placed on the labeling and/or in the instructions for use (user manual).
The legislation of some countries requires the Authorized Representative to keep documentation for submission to public authorities and/or conformity assessment bodies upon request. In some countries the Authorized Representative must be registered at the competent authority.
The Authorized Representative is designated by the Power of Attorney and/or the Agreement. The Agreement is more preferable to define the rights and obligations of both parties, the responsibility of the Authorized Representative and manufacturer with regard to quality and safety, the timing of communication, the procedure for dealing with complaints and incidents, as well as with many other aspects.
We offer the following services:
- independent outsourcing of the Authorized Representative functions, not related to the distribution and marketing processes;
- quality management system certified according to ISO 9001:2015;
- team of highly qualified employees, with excellent knowledge of national and European legislation;
- medical support from qualified medical advisors;
- third party liability insurance;
- high level of written and spoken English in communication with the manufacturer;
- strict compliance to business ethics;
- excellent long-term relations with competent authorities;
- complete support of legalization of medical devices (conformity assessment, labeling, adaptation of instructions);
- support in the disposal of medical devices in accordance with applicable laws (if necessary).
Cratia 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.