Registration of medical devices
About us
Our goal is to make the process of medical device registration easier and faster. The final objective is to legally sell medical devices in the Russian market.
We are working with all the stages of registering process starting from creating initial documentation to finally obtaning the Registration Certificate.
Stages of the national registration process
To initially select appropriate registration procedure, we need to categorize medical device according to the risk level as per local government regulations.
First class risk level and in-vitro
- Importing medical device samples
- Collecting and creating technical documentation for regulatory government agency
- Undergoing different sample testing in specialized certifed laboratories :
- technical
- clinical
- toxicological and electromagnetic compatability (if necessary)
Sending documents to government agencies
Correcting documentation as per governmental agency’s comments on the initial submission
Receiving Registration Certificate
Second class risk (A and B) and third class levels
- Importing medical device samples
- Collecting and creating technical documentation for regulatory government agency
- Undergoing different sample testing in specialized certifed laboratories :
- technical
- clinical
- toxicological and electromagnetic compatability (if necessary)
Sending documents to government agencies
- Correcting documentation as per governmental agency’s comments on the initial submission
- Receiving approval for the clinical trials
Undergoing clinical trials to obtain official protocol with the results.
Submit clinical protol with the results to the regulatory agency.
Correcting clinical protol and documentation as per governmental agency feedback.
Obtaining Registration Certificate
Our services
Preparing documentation that is required to import samples of medical device(s)
Evaluating the feasibility of registering device as a medical product based on documentation
Developing technical and user manual documentation for the medical device
Undergoing registration process as per client’s requirements and constraints
Working with certified laboratories to undergo necessary testing procedures in order to receive required protols as part registration dossier
Registering medical devices on the fast-track procedure (if medical device in question falls under appropriate cateogry to expedite the process as per regulations)
What is included in the registration process
- Evaluating feasibility of registration a device as medical product
- Import of medical device samples for testing
- Developing documentation for registration purposes using manufacturer’s technical specifications
- Selecting laboratories for sample testing based on price and time constraint parameters
- Evaluation of protocols from laboratories upon test completion
- Adapting registration dossier as per regulatory agency’s feedback after initial submission
Contact us
If you have any questions, please feel free to contact our registration specialists