Liat Nadel

Liat Nadel

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:

  1. Providing essential Medical Care
  2. Research
  3. Development & Production excluding marketing
  4. Medical Devices Use in Emergency status
  5. A Medical Device for export alone
  6. Clinical Evaluation
  7. Personal Use