Israel
Israel is a hub of technological innovation in the medical device sector, with a regulated and highly competitive market.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Ministry of Health (MOH) – Medical Device Division (AMAR).
Device Classification:
- Class I: Low risk
- Class IIa, IIb: Moderate risk
- Class III: High risk
Specific Local Requirements
| Language | Documentation in English or Hebrew. |
| Local Representative | Required for foreign manufacturers. |
| Certifications | CE, FDA, and ISO 13485 facilitate the process. |
Challenges and Operational Advice
- Strict regulations: Market access requires high compliance with requirements.
- High competitiveness: A well-planned market entry strategy is essential.
Why Choose ISEMED
- Experience in Israel
In-depth knowledge of local regulations. - Specialized Support
Assistance with the registration process with AMAR.
FAQ
- Is a local representative required? Yes.
- Documentation language? English or Hebrew.
- License duration? Licenses are subject to the expiration date of the device’s CE certificate.