The medicinal products market has grown rapidly over the past decade. The regulatory basis for medicinal products and medical devices is updated annually. Different classes of medical products are recognized by regulatory bodies that are a result of usage characteristics and potential harm. But where to turn if there was a question about the need for the registration of medical devices in Kyrgyzstan?
REG MED SERVICE company that has many years of experience of successful and spotless work at the healthcare market, has become a recognized leader in marketing authorization of medical equipment, registration of medical products in Kyrgyzstan.
We know from our experience that not everyone owner is ready to establishing and maintenance of relations with regulatory bodies that directly involved to the assessment of medical products of the national and foreign manufacturer. Registration of medical devices in the Kyrgyz Republic is a responsible way that requires time and effort. The following documents need to prepare in order to obtain of registration number and marketing authorization:
- Letter of application;
- Registration Dossier,
- Sample of medicinal products;
Also, the following procedures are implemented during the registration process:
- assessment of registration dossier for a medical product;
- technical and clinical trial;
- processing of technical and clinical trial results;
- granting of a medical product implementing protocol;
- granting of marketing authorization;
- including to national registry.
You need the help of professionals in order to avoid mistakes during the preparation of documents for the registration of medical products – this will help make the process quick and convenient. In turn, we guarantee compliance with the following rules:
- Confidentiality — strict adherence to the requirements of security regarding the client’s developments;
- Quality — high level of services;
- Responsibility — warranted conformity of work results to all requirements of the client;
- Professionalism — many years of experience demonstrating competence in the field of provided services, efficiency and reliability of the performed work;
- Terms — compliance of deadlines approved by the client.
Specialists of Reg Med Service company ready to provide counsel to you at any time and complete legal assistance at each stage and to prepare of ready to use dossier at minimal time.