Question 1

What is AMAR and why is it important for medical device manufacturers?

Accepted Answer

AMAR (Division of Medical Devices and Accessories Registration) is the unit within Israel's Ministry of Health (MOH) responsible for regulating medical devices. AMAR oversees device registration, conformity assessment recognition, quality standards compliance, and post-market surveillance. All medical devices marketed in Israel must be registered with AMAR, and foreign manufacturers must designate a local Israeli agent. Israel recognizes CE marking and other international certifications, which can expedite the registration process.

Question 2

What are the main medical device registration requirements in Israel?

Accepted Answer

Device Registration: All medical devices must be registered with AMAR before commercialization, Israeli Standard 1744: Compliance with IS 1744 (aligned with ISO 13485) or equivalent international standards, CE Marking Recognition: CE-marked devices with valid EU Notified Body certificates are generally accepted, Israeli Agent: Foreign manufacturers must designate a local agent in Israel, Technical Documentation: Declaration of conformity, certificates, labeling (Hebrew language requirements), instructions for use, Quality System: Evidence of ISO 13485 certification or equivalent QMS. The registration process typically takes 1-3 months for devices with recognized certifications.

Question 3

What is Israeli Standard 1744 and how does it relate to international standards?

Accepted Answer

Israeli Standard 1744 (IS 1744) is the national standard for quality management systems for medical device manufacturers, closely aligned with ISO 13485. Key Features: Mirrors ISO 13485 requirements for quality management, includes additional Israeli-specific labeling and language requirements, recognizes international QMS certificates (ISO 13485, FDA QSR, MDSAP). Compliance Options: Direct IS 1744 certification from Israeli certification bodies, recognition of ISO 13485 certificates from accredited international bodies, acceptance of other recognized QMS frameworks. Manufacturers with ISO 13485 certification typically have streamlined paths to Israeli market compliance.

Question 4

How does Israel recognize CE marking and international certifications?

Accepted Answer

Israel's regulatory system facilitates market access by recognizing CE marking and other international certifications: CE Marking: Devices with valid CE marks from EU Notified Bodies are generally recognized, expediting registration, FDA Clearance/Approval: US FDA 510(k) clearances and PMA approvals are also recognized, Other Markets: Certifications from Canada, Australia, Japan may be accepted depending on device type, Streamlined Process: Recognized certifications reduce technical review requirements, focus shifts to labeling and local requirements. Note: Registration with AMAR still mandatory regardless of international certifications; recognition simplifies but does not replace registration.

Question 5

What is an Israeli Agent and is it required?

Accepted Answer

An Israeli Agent (also called Local Agent or Authorized Representative) is a person or company established in Israel designated by a foreign manufacturer to act as their local representative with AMAR and the Ministry of Health. Requirements: Must be domiciled in Israel with a valid business license, registered with AMAR, Responsibilities: Submit and maintain device registration applications, serve as liaison with AMAR and MOH, maintain technical documentation and certificates, handle post-market surveillance and adverse event reporting, coordinate recalls and field safety corrective actions. An Israeli Agent is mandatory for all foreign manufacturers (including EU and US companies) marketing medical devices in Israel.

Question 6

What are the labeling requirements for medical devices in Israel?

Accepted Answer

Israel has specific labeling requirements, particularly regarding Hebrew language: Hebrew Language: Labels and instructions for use must include Hebrew text, Bilingual Labels: English/Hebrew or original language/Hebrew combinations are common, Required Information: Device name, manufacturer information, Israeli Agent details, intended use, classification, batch/serial numbers, manufacturing date/expiration, warnings and precautions in Hebrew, Symbols: International symbols (per ISO 15223) are acceptable with Hebrew explanations if needed. Practical Approach: Many manufacturers use label overlays or inserts to add Hebrew content to internationally labeled devices, avoiding separate production runs.

Question 7

How often is Israeli medical device regulatory news updated and how can I stay informed?

Accepted Answer

AMAR and the Israeli Ministry of Health periodically publish updates to registration procedures, standards, and safety alerts. Changes may affect device registration timelines, CE recognition policies, and local requirements. Our platform aggregates daily updates from 7 premium commercial sources including RAPS, Emergo by UL, Pacific Bridge Medical, and Citeline. We recommend checking this page regularly and monitoring MOH announcements for changes affecting Israeli market access.

Question 8

What commercial sources does this platform use for Israel news?

Accepted Answer

We aggregate Israeli regulatory intelligence from 7 premium sources: RAPS (Regulatory Affairs Professionals Society), Emergo by UL, Citeline MedTech Insight, Pacific Bridge Medical, Asia Actual, Pure Global's proprietary research, and Qualtechs. These sources provide expert analysis, real-time updates, and strategic insights beyond basic AMAR announcements, helping you navigate device registration, CE recognition, Israeli Agent designation, and Hebrew labeling requirements.

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