Registration of medical devices is the essential stage of import process aimed at getting approval for their application on the territory of Kyrgyzstan. It consists of an expert evaluation of a registration dossier, as well as analysis of submitted copies for compliance with safety and efficiency requirements for humans and the environment.
Registration of medical products in Kyrgyzstan is a procedure that involves obtaining a certificate of its passage by a natural or legal person responsible for manufacturing, quality, the harmlessness of medicines used (sold, manufactured) in Kyrgyzstan.
In order to protect consumers from substandard medicines, it is necessary to conduct the following procedure for registration of medical devices in the Kyrgyz Republic:
- submitting an application and a letter of intent on the necessity of obtaining this certificate in two copies;
- creating of a registration dossier meeting the requirements of the Technical Regulations;
- sending several samples of medical devices for carrying out technical and clinical tests;
- payment for services rendered;
- issuing of completed documents to a customer;
- inclusion of registered products in the state register.
The applicant guarantees the timely provision of additional information in case of a justified claim.
Are there companies registering medical products in Kyrgyzstan?
Today in Kyrgyzstan there are specific companies that offer qualified assistance in the process of registration of medical devices. “Reg Med Service” provides services concerning the assessment of various medical devices conformity with the Technical Regulations, preparation of accurate set of necessary documents, supervision of products until the certificate of registration is issued, as well as translation of medical documentation. The professional team of Reg Med Service” possesses the requisite knowledge, experience, and skills for successful completion of these works.
Approaching our company you will save precious time, energy and money.