Israel is known as one of the global leaders in medicine and biotechnology. The country actively develops startups, manufacturers of medical electronics, laboratory and diagnostic equipment. However, before any medical device can enter the Israeli market, it must undergo mandatory certification. This process confirms that the product is safe, effective and compliant with local and international standards.

Who Regulates Medical Certification in Israel 

The main government body is the Ministry of Health (MoH). It is responsible for the registration, control and certification of all medical products, including electronics, diagnostic systems, monitoring devices, implants and laboratory equipment.
Assessment is conducted according to local regulations and international standards such as IEC 60601, ISO 13485 and GMP.

Main Categories of Medical Equipment 

Medical electronics are classified by risk level.

• Class I – low risk (non-invasive devices, simple diagnostic tools).
• Class IIa and IIb – medium risk (monitors, laboratory analyzers, infusion pumps).
• Class III – high risk (life-support devices, implants, respiratory and circulation support systems).

The class determines the depth of assessment, testing volume and required technical documentation.

Key Features of Medical Electronics Certification 

Certification in Israel requires compliance with two core directions.
1. Safety – electrical safety of the equipment
Insulation, grounding, overheating resistance and patient-operator protection are checked. The main standard is IEC 60601-1 and its localized Israeli version.
2. EMS – electromagnetic compatibility
IEC 60601-1-2 tests evaluate whether the device creates electromagnetic interference and whether it is resistant to external fields. This is critical for hospitals where many systems operate simultaneously.
Additionally, the assessment includes:

• software and quality control according to ISO 62304;
• biocompatibility of materials according to ISO 10993;
• clinical data confirming effectiveness.

Documentation Required for Submission to the Ministry of Health 

To obtain permission for sale or import, the manufacturer must prepare:

• technical description and user manual;
• test reports for IEC 60601 and EMS;
• ISO 13485 certificate;
• registration dossier and manufacturer declaration;
• data on previous CE, FDA or other approvals (if available);
• translation of documentation into English or Hebrew.

After review, the Ministry issues an approval certificate or registration number that authorizes market access.

Recognition of International Certificates 

Israel accepts some international reports such as CE, FDA, CB Scheme and MDSAP. This speeds up registration and reduces costs for manufacturers with existing approvals. Local confirmation is still required, including via an authorized representative in Israel.

Why Certification Matters 

Successful certification ensures:

• legal access to the market and government procurement;
• trust from clinics and distributors;
• confirmation of safety and quality;
• stronger international positioning.

For startups and manufacturers, this is also an important step for attracting investment and forming partnerships with medical networks.
WorldWideBridge provides full-cycle medical electronics certification in Israel – fast, professional and fully compliant with Ministry of Health requirements. We handle everything from documentation analysis to obtaining the official certificate so your product can confidently enter the market.