Israel issues new Medical Device Law 2012

The Israeli parliament passed in May 2012 a new legislation.
A new law for “Medical Devices – 2012” has completed all phases.
This effort made by a subcommittee of the Labor, Welfare and Health committe, took over a decade of discussions and debates to be completed.
The law was published on May 14th, 2012 and will become valid in 60 days.
Some sections will come into force within a year.
The law covers the manufacture, marketing, distribution, recycling and use of medical devices.

Some highlights: 

  • Under this legislation, all medical devices must be registered (mandatory) with the Ministry of Health.
  • The license will include the approved use / indication.
  • The license holder will have to comply with license terms. The MoH director may exempt from registration, devices for research or limited use in clinical trials.
  • New guidelines will handle an off label use of devices.
  • The license holder will also need to monitor adverse events and advise on recalls etc.
  • Renewal of license must be submitted 4 months ahead of license expiry.
  • Pharmacovigilance system and adverse event monitoring and reporting are required from manufacturer and importer.
  • Penalties for incomplete applications, starting from one month “hold/ block” for resubmission and escalating.

Should you need a translation of this law to English, or additional insights, please contact us.
Translations to English are available for: M
edical Device Law (2012)
as well as Medical Device Regulations (2013). 

A sample of translation of law:

The Israeli Ministry of Health emphasizes the importance of keeping public safety and allows only safe, efficacious and high quality medical devices reach the market.

Medical Equipment Law (Israel), 2012

Mind Pharma, managed by Shavit Fragman provides Appointed Pharmacist Responsible Pharmacist – Qualified Person (QP) & batch release Qualified Person Pharmacovigilance (QP-PV) and Medical Director services.
We also support establishing quality assurance system management, writing SOPs, audits, mock audits, quality and technical agreements.
Need more information? Contact us here.

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