Registration of medical devices
Comprehensive support of medical device registration - fast and professionally
Comprehensive support of registration of medical devices
Our special regulatory department is engaged in supporting the registration of medical devices. The leading specialists and professionals of our company control this process from the beginning to the end: from preparing a set of documents to close cooperation with the expert community. To date, our registration department has received over 350 authorizations in the Russian and CIS markets.
Execution work stages
Stage 1
Request for a technical file, development of technical conditions, formation of a registration dossier
Stage 2
Technical, toxicological and clinical trials
Stage 3
Expertise conducting by FSBI
ALL-RUSSIAN RESEARCH AND TESTING INSTITUTE OF MEDICAL TECHNOLOGY or FSBI TsMIKEE of Roszdravnadzor
Stage 4
Successful expertise completion
Advantages
Experienced team
- Our staff consists of experienced specialists who have received more than 350 authorizations
- Our specialists work closely with the Federal Service for Surveillance in Healthcare
- Every year our specialists take advanced training courses
Full support at all stages
- A dossier submission to Federal Service for Surveillance in Healthcare
- Documentary verification of the registration dossier
- Identified comments elimination (if any)
- Obtaining permission to conduct clinical trials
- Submission of clinical trials to Federal Service for Surveillance in Healthcare
Launching the drug on the market
- We cooperate with leading distributors
- We organize supplies to the largest pharmacy chains
- We provide comprehensive marketing maintenance