Liat Nadel – Jurist – Regulatory Affairs & Import Export Expert Medical Devices – VP RA Affairs & COO L.S. Marketing & Registration
Notifications are published on EU Level after receiving the CE Approval
- No legal obligation of the authorities to reply
- Registration in several countries in Europe
In some countries in Europe there is an obligation of registration the Medical Device like: Italy, Portugal, France ,Greece ,Latvia
A Medical Device will be registered in Israel by an Israeli citizen or by a corporation registered in Israel- Israeli Registration Holder.
The validity of the registration in the Register will be determined according to various Registration Periods of the approvals – CE , ISO13485, FDA 510K etc..
Medical Devices which not always need registration in Israel are the following:
- Providing essential Medical Care
- Development & Production excluding marketing
- Medical Devices Use in Emergency status
- A Medical Device for export alone
- Clinical Evaluation
- Personal Use