Medical Device Registration Document Update Service

The process to amend registration documents begins when changes are needed in the registration document set, and these changes do not affect the information in the registration certificate itself. Various reasons can necessitate these changes.

Changes to the registration certificate (which do not require safety, quality, and efficacy checks) are made in the following situations:

1. Changes in applicant information.
2. Updating details of the individual who will receive the registration certificate.
3. Changing the production location address for the medical device.
4. Renaming the medical device.
5. Manufacturer’s alterations to the validity period of documents in the registration dossier.
6. Updating information about the medical device manufacturer’s authorized representative.

Complex Changes Requiring Further Assessment

More complex dossier changes, related to the composition or characteristics of the medical device, require a reevaluation similar to the initial registration check. This includes conducting additional tests and forming an updated document set. Our team coordinates these additional checks with relevant experts, oversees the additional testing, and compiles an updated registration dossier, ensuring subsequent approvals.

Leverage Our Decade of Experience in Medical Device Regulation

Whether you need minor administrative changes or significant technical updates, our comprehensive experience with Russian processes ensures seamless registration updates. For any query regarding registration document amendment (VIRD), our experts will analyze your situation and develop a precise and efficient VIRD strategy, aiming for minimal execution time.