With our expertise in regard to medical devices regulatory services, we offer:
- Registrations, renewals, variations and additions to the registrations of medical devices in the Register of Medical Devices (classes I, Is, Im, IIa, IIb, III, selftesting etc..)
- Maintenance of the registrations and submissions of updated documents
- Submissions of the requests for additional labels and creating the additional labels for submission
- Consulting regarding the promotional materials and submission of the requests for approval by the Agency
- Vigilance of the medical devices
- Application for the approval of interventional import of non-registered medical devices