When it comes to medical device registration in Israel, understanding the different pathways for registering and renewing medical devices is crucial for compliance and continued market access. The blog highlights the existing registration pathways in the medical equipment registry.
1. License Renewals of Medical Devices in Israel – By Declaration
This registration pathway is designed for low-risk medical devices (Class I) and low-risk in vitro diagnostic (IVD) devices. Here are the key details of medical devices license renewal and registration:
- Registration is carried out based on the registrant’s declaration.
- The pathway applies to medical equipment registered and marketed only in recognised countries.
- This process is independent and immediate, done through the vault, following the instructions on the website.
Applications can be submitted starting October 1st of each calendar year for the following year. For example, an application submitted on 1.10.2024 will be valid until 31.12.2025.
2. Fast-Track Medical Devices License Renewal & Registration Process
The fast-track registration process applies to medium-risk medical devices (Class II) and medium-risk in vitro diagnostic (IVD) devices. Key features of this medical device registration in Israel pathway include:
- This process is only available for devices registered and marketed in recognized countries.
- Processing times for requests on this track are shorter than on the regular track.
- Requests submitted via the regular track may be transferred to the expedited track, following the guidelines outlined in the procedure of registration and license renewals of medical devices in Israel.
3. Regular Medical Devices License Registration
This pathway is suitable for high-risk medical devices (Class II and Class III) and laboratory equipment (IVD) with equivalent risk levels. Here’s what you need to know:
- This process applies to both medical devices manufactured in Israel and those that are not marketed in recognized countries.
- It is also relevant for medical devices license registration for products with higher risk levels.
Not sure where to start? That’s exactly where we come in!
We are here to help you complete the medical devices license registration process smoothly, quickly, and accurately.
Don’t wait until the last minute!
Contact us today, and we will accompany you through the registration or renewal process, so you can continue to operate with peace of mind, knowing that everything is in order.
Contact us now, and let’s start working together!
For questions or additional details on Medical Device Registration in Israel – we are here for you.
