Services of registration and notification of medical products
We intermediate between manufacturers and state institutions in registering medical products and medical devices. We assist in carrying out notification procedures, preparing statements of a set form to competent institutions about new medical products and devices being placed on the market.
We perform the following operations:
- Preparation of registration/re-registration dossiers of medical products, revision of the dossiers prepared by a customer, preparation of documents for variations
- Matching of packaging texts of medical products, medical devices, etc. with the labelling text approved by the agency/institution
- Representation of customer’s interests in agencies/institutions
- Submission of documentation to the agency and following of different processes (registration, variations)
- Representation of manufacturer’s interests in various countries
- Completion of notification applications and accompanying documents and their submission to competent institutions
