Medical Device Regulatory Requirements in Israel
| Regulatory Authority |
Ministry of Health |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
Israel does not have its own classification system but it recognizes USA, Europe, |
| Medical Device Regulations |
Licensing of medical equipment
| Click Here
|
| Registration Process |
Registration of medical equipmentInstructions for submitting an application for the registration of an AMR medical device / accessory at the Ministry
| Click Here
|
| Registration Timeline |
4 months |
| Requirement of Authorized Representative |
YES |
| Language Requirement |
Labels must be in Hebrew and Arabic (for home-use products) and English Language |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 24/May/2025