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.
- 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: Medical 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.
- 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.