1. Introduction, general information
Brief information about legislation in medical devices, steps of state.
.2. New registration of medical device
Brief scheme, particularities, fees and list of services for new registration of medical device.
3. Renewal of registration of medical device
Brief scheme, particularities, fees and list of services for renewal of registration of medical.
4. Separate services in registration of medical device
Preparation of the dossier, technical expertise, preclinical and clinical studies.
5. Structure of the registration dossier
Legal requirements to the structure of the documentation for registration of the medical device in Ukraine.
6.
Commercial offer for registration of medical device
7. Legislation in the registration of medical devices
Current legal acts in the field of registration and renewal of registration of the medical devices in Ukraine.
8. Certification of the manufacturing site
.
9. State registry of medical devices of Ukraine
State registry of medical devices in Ukraine is the centralized source of the information about all registered medical device in Ukraine , it's manufacturers, EAN codes and other information on the marketing authorization.
|