Israel Device Declaration Registration

Israel Device Declaration Registration – Part II 

Our previous article on this topic explained that starting in January 2024, medical device manufacturers can register low-risk class I (class I, Is, Im, Ir) and FDA low-risk medical devices in Israel via the newly introduced Israel Device Declaration Registration route. This process should be performed by the Israel Registration Holder (IRH) or an importer who holds an ISO 9001 certification. This part provides more details about the new Israel Device Declaration Registration route.

Instructions For Preparing an Israel Device Declaration Registration

The first good news is that no fees are collected for new, changed, or renewed registration in Israel Device Declaration Registration. Previously (in the “regular” route), the registration fee was NIS 1200.
The declaration registration file should include up to 7 files:

1. Submission letters

This folder includes signed declaration documents for registration, renewal, or change of registration. These forms can be downloaded from the Israel Ministry of Health’s website. The appropriate document must be selected according to the type of declarant: “individual” or “corporation” and according to the type of registration request: new/renewal/change.

2. Regulatory approvals

This folder may contain four sub-folders where the available product regulatory approvals are attached:
• FDA – 510K, CTFG, or Reg & Listing
• CE  Certification (EC)
• DoC – Declaration of Conformity
• Other: regulatory approvals from other authorities (e.g., Canada, Australia, Japan, etc.)

3. Importer documents

This folder includes Quality management system (QMS) certificates (ISO 9001 or GMP) of the IRH or importer

4. Manufacturer’s documents

QMS certificates of the manufacturer (e.g.: ISO 13485)

5. Technical documents – not mandatory

6. Catalogs – catalogs, instructions for use, and labels

7. Covering letters – not mandatory

Only the folders containing documents should be attached. Please keep the folder numbers as defined.

Renewal and Change of Registration in the Declaration Route

A registration renewal request will be submitted similarly to the submission for the new registration. The registration owner will submit an annual declaration every year at the beginning of the following calendar year, starting from October 1 of the current year.

A request for a change of registration shall include a declaration document for the corresponding change of registration and only the documents relevant to the change.

Submitting a New Registration

The applicant should fill in all the mandatory fields in the PDF application form according to the instructions. The system will reject a form that is not filled in as required.

Initial confirmation of receiving the documents in the Ministry of Health’s portal will be displayed on the screen within a few minutes following the sent application. The message “This file has been sent successfully” will only be sent to the applicant’s email box. The applicant is the person whose email address appears as the applicant on the application form.
An automatic message (technical confirmation) will be sent to the applicant’s email box within 4 hours.
If the application was not sent according to the instructions, an appropriate automatic message notifying the person submitting the application that it has been rejected will be sent to his or her e-mail box within 4 hours.
The registration confirmation in the medical equipment register will be sent immediately after the application is received in the registration system but no later than 48 hours.

Important to Know

Please note that it is possible to independently transfer the registration of a product registered in the register (previously registered and which already has a registration number in the register) from “regular route” to “declaration route”, by submitting a request to renew or change the registration in the register. The registration number in the register must be indicated at the time of submission, including the correct coding.

Also, it is possible to independently transfer a request for renewal or change for a product from a “regular route” to a “declaration route.” This option is available for applications awaiting review and for which a “submission confirmation” has been received. Please note that it is impossible to transfer a new application that has been submitted and is awaiting review in the normal route. In this case, the applicant must contact the Israel MoH by email to close the application first.

BioReg Services

Don’t hesitate to contact us if you need any assistance with Israel Device Declaration Registration or any other Regulatory Service

BioRegards,

Daniel