Contact Person and Qualified Professional Requirements Under Israeli Medical Equipment Regulations

1. Key takeaways

Regulation 21 of the Israeli Regulations requires the applicant to appoint, from among its employees, a contact person responsible for submitting applications and answering the Director’s inquiries. The appointment must be made in writing, with copies sent to the Director and to the medical institutions that purchased the equipment. Regulation 22 goes further: for three categories of devices, the contact person must be a qualified professional with specific credentials: (1) life-support and life-sustaining equipment and implants; (2) devices incorporating pharmaceuticals, handling blood products, or containing animal-origin substances; and (3) imaging equipment, equipment emitting ionizing or non-ionizing radiation, and laser equipment. This is a role-based qualification requirement and cannot be replaced by an outsourced service contract.

• The contact person must be an employee, not an external contractor or a service provider acting at arm’s length.
• The appointment must be documented in writing and copied to the Director and to the purchasing medical institutions.
• For three defined risk categories, the appointee must hold specific professional qualifications set out in Regulation 22.
• Training documents must accompany the application when it is submitted by a qualified professional.
• Departure of the named individual creates a compliance gap until a new written appointment is made and circulated.

2. Legal basis

The contact person and qualified professional obligations are set out in the Medical Equipment Regulations (Registration of Medical Equipment in the Register and Renewal thereof), 5773-2013, and are anchored in the parent Medical Equipment Law, 5772-2012. The table below lists the instruments and provisions relied on. Regulatory information was verified as of October 29, 2026 against official Israeli legal databases and authoritative public sources; AMAR procedural documents are updated frequently, so the current version on the Israeli Ministry of Health website governs before formal submission.

3. Expert insights

The qualification list in Regulation 22 is grouped by the risk profile of the device, and the underlying logic is easy to follow once the three groups are read side by side.

Group one: life-support and life-sustaining equipment, and implants. The accepted qualifications are physician; bachelor’s degree in life sciences or medical sciences; or registered biomedical engineer. What this group protects against is the severity of clinical consequences: failure of such a device directly endangers life, so the person behind the application must understand clinical reality.

Group two: devices incorporating pharmaceuticals, handling blood products, or containing animal-origin substances. The accepted qualifications are the group-one persons, or a licensed pharmacist. This group addresses compound risk arising from substance interaction, which is precisely why the pharmacist is added to the pool of acceptable professionals.

Group three: imaging equipment, equipment emitting ionizing or non-ionizing radiation, and laser equipment. The accepted qualifications are the group-one persons, or a registered electronics engineer or a bachelor of physics. This group addresses energy and radiation risk, which is why engineering and physics backgrounds are brought in.

Three practical inferences deserve attention.

First, this is a requirement on the person, not on the company. Regulation 21 expressly requires the contact person to be appointed from among the employees. An IRH cannot satisfy the requirement on the strength of its corporate credentials alone; it must have an employed individual who holds the relevant qualification.

Second, the training documents must be filed with the application. Regulation 3(a)(13) provides that applications submitted by a qualified professional must attach the training documents required by Regulation 22. Diplomas, professional licences and training records must therefore be assembled as part of the dossier, not treated as an afterthought.

Third, staff departure creates a compliance gap. When the contact person changes, a new written appointment must be made and sent to the Director and to the medical institutions. Companies should build this step into their personnel change contingency plans, so that a resignation letter does not silently suspend the regulatory function.

Taken together, the structure of Regulation 22 can be read as a mapping from clinical risk to professional competence. The regulator is not asking the applicant to employ a specialist for its own sake; it is asking that the person who stands behind the application in front of the Director is able to understand what can go wrong with the device in question. For manufacturers selecting an IRH, this means the availability of a properly qualified employee should be checked at the same time as the ISO 9001 certificate, because the two conditions are independent of each other and both are mandatory wherever the category applies. A candidate that passes on one and fails on the other is not a candidate.

4. Practical recommendations

• Confirm whether a qualified professional is required for the category. Work through the three-category list item by item; do not assume the requirement does not apply.
• Make the appointment letter written and circulate it. The contact person appointment must be made in writing, with copies sent to the Director and to the medical institutions that purchased the equipment.
• Archive the training documentation. Diplomas, professional licences and training records belong in the submission package (Regulation 3(a)(13)).
• Plan for personnel changes. Write the re-appointment procedure for contact person changes into the quality system documentation.

5. Verification checklist

• □ Whether the product falls within the three-category list in Regulation 22 has been determined
• □ The contact person has been appointed in writing from among employees, with copies sent to the Director and to medical institutions (Regulation 21)
• □ The qualified professional’s academic or professional credentials have been verified (physician / life sciences graduate / biomedical engineer / pharmacist / electronics engineer / physics graduate)
• □ Training documents have been submitted with the application in accordance with Regulation 3(a)(13)
• □ The re-appointment procedure for personnel changes is written into the quality system documentation
• □ Copies of the appointment letter have been archived by the IRH

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Israeli market. Our team coordinates local importer arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com