The new Israeli Medical Device Law - Major Points- Taken from Medical Device Law 5772-2012

Written by     Published in Blogs on 12 December 2017

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

 

Renewal of Medical Devices in Israel- An application will be submitted in the Register at least 4 months prior to the expiry of the existing Amar- approval. If the dossier has been submitted, the registration shall be considered to have been extended until MOH decision regarding the renewal.

Registration in Israel- can be done only for 1 family of products per dossier , with same risk class.

The registration is acc. to the EU Directive and /or the FDA , Canada , Australia , actually according to the relevant recognized countries by MOH.

Recognized countries by MOH Israel for registration in Israel are as follows:
Austria, Australia , Italy ,Island ,Ireland, USA, Belgium, UK, Germany, Denmark, Holland ,Greece, Norway, New Zealand, Spain ,Portugal, Finland, France, Canada, Sweden, Switzerland

Manufacturers - need ISO 13485 and CE for class I sterile, Im ,IIa, IIB,III devices
Distributors - at least ISO 9001
Up to 3 manufacturing sites per dossier

Separation of :

  • Sterile and not sterile products will be registered separately
  • implants , unless they are included in 1 system
  • Different Classes – Risk levels of products , unless various classes are 1 system +accessories
  • Biological and non biological products
  • OTC & Professional Devices

Registration procedure in Israel takes -minimum / approx. 120 Days

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Liat Nadel

Liat Nadel – Jurist – Regulatory Affairs & Import Export Expert Medical Devices – VP RA Affairs & COO L.S. Marketing & Registration