Introduction of amendments to the marketing authorization file and to the marketing authorization
The registration documentation (marketing authorization file and marketing authorization) must be up-to-date
Consultation, inspection of documentation for a medical device
An initial analysis of information on the medical device and its documentation shall be conducted. A schedule for introduction of amendments to the marketing authorization file is drawn up, and if necessary, updating of the Marketing Authorization File documentation and testing shall be included.
Drawing-up of the application, tests, preparation of the set of documents
A well-composed application considerably favors the success of further procedure of entering changes to the marketing authorization file. The necessary accredited laboratories are selected. Our specialists pay a particular attention to ensure that the quality, performance and safety of the medical device is documented.
Submission to Roszdravnadzor
Specialists of the Fronika Group company have a successful experience in the introduction of amendments to the marketing authorization file. We select for you the least expensive way to update the documentation for a medical device.
Receiving notifications about the process of introduction of amendments to the marketing authorization file and to the marketing authorization
The process is structured so that you do not have to spend significant financial and time resources to make amendments to the marketing authorization. You have a round-the-clock access to the up-to-date information on the work progress via your Personal Account on our website.