Why choose us
Turnkey registration: from strategy to submission
Registration of a medical device is a complex process that requires compliance with legal requirements, proper preparation of documentation and interaction with government agencies and expert organizations. Our specialists fully take care of the registration procedure, allowing you to focus on business development.
We take on the regulatory part of the project: we analyze the product, determine the registration route, create a set of documents, support testing, submission and responses to comments so that the manufacturer understands the procedure, deadlines and areas of responsibility at each stage.
What is included in the service
We support the registration of a medical product at all stages:
- analysis of the product and determination of the optimal registration path;
- determining the class of potential risk and checking the need for testing;
- analysis of existing documentation and identification of missing documents;
- development and revision of technical, operational and registration documentation;
- organization of technical, toxicological and clinical tests;
- preparation of a complete registration dossier;
- submission of documents to Roszdravnadzor;
- support of the examination and interaction with the expert organization;
- preparing responses to requests from experts;
- monitoring the completion of all stages of registration until obtaining a registration certificate.
Result
As a result, you receive a registration certificate for a medical product, a prepared set of documentation and full support for the registration procedure without the need to independently interact with government agencies and expert organizations.
