CERINS will help you register a new medical product at "General Directorate for Quality Control of Medicines and Medical Equipment of the Republic of Uzbekistan." The advantage of the CERINS is the implementation of the turnkey registration procedure, providing services for the translation of documents, filing a package of documents to regulatory bodies, acceptance and customs clearance of samples.
Our specialists will ensure the preparation of the necessary documents and samples of products. We can supervise all stages of registration.
The registration process takes place in several stages:
- Application for registration of the product, exclusively for medical purpose and preparing documents package;
- Registration department - the stage of the initial examination of the application with the provided samples and registration documents of medical devices. After positive results of the initial examination are obtained, samples and registration documents are sent to the State Center for further examination;
- evaluation of normative documents, tests for compliance with all norms of normative documents, a medical product or a medicinal product, for further transfer to the Committee on New Medical Equipment;
- examination of clinical trial materials, protocols of laboratory analyzes, technical part of registration documents, biological, chemical and administrative expertise at Committee for New Medical Technology;
- issuing a registration certificate (or refusal to register).
The validity period of the issued certificate is 5 years.
It should be noted that the registration process is very complicated, as it affects all committees of the General Directorate and requires considerable time expenditures.
Similarly, the company CERINS provides services for the state registration of a medical device in Russia and Kazakhstan.