AMR approval (medical-device approval) is the official registration and approval of medical equipment at the Israeli Ministry of Health. Without the approval, it's forbidden to market, sell or import medical equipment in Israel. CBE guides manufacturers and importers from the technical dossier to receiving the approval.
CBE specializes in guiding and certifying organizations for the AMR Approval standard, tailoring the management system to the organization's needs.
Quick facts – AMR Approval
Goal
Registering medical equipment for legal marketing in Israel
Who needs it
Manufacturers and importers of medical equipment
Importance in Israel
Medical equipment may not be marketed without AMR approval
Complements
ISO 13485, ISO 27799, registered importer
CBE – success rate
100% – hundreds of medical-equipment registrations
AMR approval (medical-device approval) is the official registration and approval of medical equipment at the Israeli Ministry of Health. All medical equipment — from monitoring devices, to implants, to medical software — must be registered before marketing, sale or import in Israel.
The registration requires submitting a full technical dossier, proof of compliance with relevant standards, a quality management system (usually ISO 13485), and sometimes clinical evidence. The Ministry of Health reviews the dossier and grants the approval.
CBE guides manufacturers and importers through the entire registration process — from preparing the technical dossier, through the standards and quality system, to receiving the official AMR approval from the Ministry of Health.
Medical equipment may not be marketed in Israel without AMR approval.
The registration is done at the Israeli Ministry of Health.
Requires a full technical dossier and proof of compliance with standards.
Official approval enabling legal marketing of the equipment.
Manufacturers of medical devices must register before marketing in Israel.
Importers of medical equipment from abroad need AMR approval before import.
Software defined as medical equipment (Software as a Medical Device) must be registered.
Monitoring, diagnostic and medical-imaging devices must be registered.
Medical implants and disposable equipment require AMR registration.
HealthTech startups must register before launching a product.
AMR approval is a condition for marketing medical equipment in Israel
Proof of the equipment's safety and efficacy is approved by the Ministry of Health
Hospitals and HMOs require only registered equipment
AMR approval enables legal import and a basis for export to other markets
Defining the organization's needs, stakeholders and the scope of the quality management system.
Process planning and control, managing customer requirements, external providers and output control.
Management commitment, quality policy and defining roles and responsibilities.
Measurement, analysis, internal audit and management review.
Risk and opportunity management, quality objectives and plans to achieve them.
Managing non-conformities, corrective actions and continuous improvement of the system.
Resources, employee competence, internal communication and documentation.
CBE performs a full Gap Analysis and builds a work plan tailored to your organization.
Manufacturers and importers of medical equipment are sometimes required to meet additional standards
CBE accompanies you at every stage — from the technical dossier to AMR approval
Determining the risk classification of the medical equipment (A/B/C/D)
Preparing a full technical dossier — specs, standards, clinical evidence
Preparing a required quality management system (ISO 13485)
Submitting the dossier and application to the Ministry of Health
Guidance until receiving the approval and official registration
CBE's professional team knows medical-equipment registration inside out
Committed to success! No approval — you don't pay.
Hundreds of medical-equipment registrations we've guided with the Ministry of Health.
CBE's team assembles the technical dossier and documents for you.
We adapt the schedule to the launch or import deadline.
AMR, ISO 13485, ISO 27799, registered importer — under one roof.
Experience with medical companies from startup to corporation.
Medical-equipment registration is a central component of Israeli medical regulation. Manufacturers and importers are sometimes required to hold several parallel approvals and standards. CBE manages all the tracks under one roof.
About CBE's GRC frameworkCBE specializes in guiding and certifying organizations for the AMR Approval standard. The service is provided by CBE's experts, with 30 years of experience in ISO standards, over 4,000 satisfied clients and 100% success in audits.
Tell us about the medical equipment — we'll come back with a requirements map and a registration plan