Israel Medical Device Registration

New Israel Medical Devices Registration Process

According to Israel Medical Device Law, the medical device submission application should be made through a professional and skilled party, the Israeli Registration Holder (IRH). IRH must be by an Israeli citizen or a corporation established in Israel and be ISO 9001 certified.
BioReg Services is an Israeli regulatory affairs boutique consultancy firm with more than 15 years of experience in Regulatory Affairs and liaison with the Israeli Ministry of Health Medical Device department (Israel MoH – AMAR) and hundreds of registered devices.

From January 2024, according to the new Israel Medical Device Registration process, low-risk class I (class I, Is, Im, Ir) medical devices can be registered in the Israel medical devices register via declaration route. This process must be performed by the Israel Registration Holder (IRH), who is also an importer.

The low-risk class also includes low-risk IVD laboratory equipment, such as class A, per the IVDR regulation.

This registration option in Israel only applies to medical equipment registered and marketed in recognized countries. The registered countries include: Austria, Australia, Italy, Iceland, Ireland, United States, Belgium, United Kingdom, Germany, Denmark, the Netherlands, Greece, Norway, New Zealand, Spain, Portugal, Finland, France, Canada, Sweden and Switzerland. In addition, all CE Marking Certificates issued under the Medical Devices Regulation (2017/745, MDR) are accepted.

The application for registration of a medical device can include one of the following options:

• Single product
• A family of products (as long as all the products are from the same class)
• System (for using all parts together) provided that all products are from the same class.
• A group of products that includes several models of the same product and provided that all products are from the same class

Instructions For Preparing an Israel Device Declaration Registration

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.

Israel Devices Registration for Higher-Risk Products

For higher-risk medical devices such as Class II FDA, Class IIa, and Class IIb in the EU, manufacturers can use “fast-track” registration, which provides shorter review times by the Israel Ministry of Health (45 or 60 days) versus the regular route with 120-day reviews. A declaration route is also possible for registration renewal for Class II FDA and Class IIa & IIb EU products.

Finally, a declaration route is enabled for the change of registration, but only in cases of non-significant changes. For a better understanding of significant changes, you can consult MDCG 2020-3 (for non-IVDs) and MDCG 2022-6 (for IVDs).

The application for registration of a medical device can include one of the following options:

• Single product
• A family of products (as long as all the products are from the same class)
• System (for using all parts together) provided that all products are from the same class.
• A group of products that includes several models of the same product and provided that all products are from the same class

See below the product category summary of Enabling medical device regulation

	Registration	Renewal	Change
Class I	·        Via Declaration	Declaration	Declaration
Class II FDA	·        Regular route ·        Fast-track registration for the medical devices approved (cleared) by FDA and marketed in U.S. in last 4 months – will be registered in Israel within 45 days unless decided differently by Israel MoH.	Declaration	Declaration (non-significant changes) Fast-track registration (significant changes)
Class IIa (EU) (incl. IVDR Class B)	·        Regular route ·        Fast-track registration for the medical devices approved in the EU-recognized* country and marketed there in the last 4 months – will be registered within 45 days unless decided differently by Israel MoH.	Declaration	Declaration (non-significant changes) Fast-track registration (significant changes)
Class IIb (EU) (incl. IVDR Class C)	·        Regular route ·        Fast-track registration for the medical devices approved both in the EU and FDA and marketed there in the last 6 months – will be registered within 60 days unless decided differently by Israel MoH.	Declaration + Post-market Report	Declaration (non-significant changes) Fast-track registration (significant changes)
Class III	·        Only Regular route	Renewal submission + Post-market Report	Declaration (non-significant changes)

*The recognized EU countries include Austria, Italy, Ireland, Belgium, Germany, Denmark, Netherlands, Greece, Norway, Spain, Portugal, Finland, France, and Sweden.

The Medical Equipment Division (AMAR) informed on June 2024 that new procedures are published on the website of the Ministry of Health, including:

• Registration procedure in the medical equipment register – details of the documents required for registration.
• Procedure for renewal of registration in the medical equipment register.
• Procedure for changing registration in the medical equipment register

These procedures will come into effect as of January 1, 2025.

For each of these procedures, new versions of the registrant’s declarations for the normal and fast registration tracks are available.

The declarations accompanying the registration (new/renewal/change) in the normal registration route and the fast registration route appear in the “Registration Forms” section on the website. They can be downloaded to fill in details (in the Word version).

In addition, the wording of the letter “Global Sales Details” was updated. This document also appears in the “Registration Forms” section on the website and can be downloaded to fill in details (in Word version).

As of June 2, 2024, the Medical Equipment Division is launching a fast track for registering medical equipment in the register.
This route is the second stage of the “enabling regulation” outline, in addition to the registration route in the declaration for medical equipment with a class I risk level, launched at the beginning of September 2023.
The fast registration track is intended for medical equipment with a class II risk level or IVD laboratory equipment with a medium risk level.
The fast registration route allows you to receive registration approval in the medical equipment register in a shorter time schedule.
The instructions for submitting registration requests (new/renewal/change) in the fast track appear on the website of the Ministry of Health, in the procedure: “Instructions for registration in the register of medical equipment in the fast track.”
Applications for registration in the fast track can be submitted as of 2 June 2024, following the guidelines of this procedure.

Israel Devices Registration – Q&A

Question: Which medical devices are included in Class I medical devices within the declaration route?
Answer: Class 1 medical devices, including non-sterile, sterile, measuring, surgical, reusable medical devices, laboratory equipment, and CE IVD (class A).

Question: Which statements are needed for the Class I declaration route?
Answer: For the class I declaration route, you or IRH will need to prepare the following statements:
• A statement on the reliability of the details and that the medical device will be imported and marketed in Israel.
• A statement that the registration is the same as the medical device approved for marketing in the recognized country and that the product is marketed in that country.
• A statement that the product and the manufacturer meet all the recognized country’s regulatory requirements and quality standards.
• A statement that Israel Registration Holder (Importer) will inform the Ministry of Health of any changes in the details of the medical device specified in this statement.
• A statement that the registration holder has in his possession all the documents and certificates supporting the registration of the product.
• A statement that IRH will forward any information required to the Ministry of Health per his request.
• A statement that IRH will inform the Ministry of Health of any changes made to the product.
• A statement that IRH will report to the Ministry of Health any unusual event or recall related to this equipment in Israel or the world.

Question: According to the new Israel Medical Device Registration process, does a Class I medical device manufacturer need an ISO 13485 certificate?
Answer: The manufacturer doesn’t need an ISO 13485 certificate, but it does require a statement of compliance with the standard’s requirements.

Question: Would all these statements be part of the larger document?
Answer: Yes, all statements needed for the Class I declaration route are part of the IRH statement that will be included in the electronic form available on the Israel Ministry of Health site.

Question: Does the IRH statement need to be verified?
Answer: Yes, the lawyer needs to verify the IRH statement.

Question: What other documents are needed for the declaration process?
Answer: The following documents should be attached as a part of the declaration route:
• The regulatory approval of the country of reliance
• Instructions for use/catalog/labeling of the device

Question: Does the IRH have any obligations after the registration?
Answer: Yes, IRH is obliged to provide an Annual declaration after registration. Every holder of a registration of Class 1 products will be required to declare towards the beginning of a calendar year that all the details and documents he provided as part of the declaration are valid and will be required to attach the latest regulatory approval from the country of reliance to the extent that it has changed.

Question: What would happen if the Israeli Registration Holder does not submit an annual declaration?
Answer: A registration holder who does not submit an annual declaration will be notified that the registration is not renewed, and will be prohibited from importing additional products from the registered devices until the issue of the declaration is settled.

Question: Does the Israeli Registration Holder (IRH) need a quality system certificate?
Answer: Yes, IRH needs to have a valid ISO 9001 certificate.

Question: Will BioReg Services ask us (the manufacturer) to be included in our liability insurance certificate?
Answer: Yes, similar to the policy for the Authorized Representative in the European Union (see MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)), the IRH must be included in the client’ liability insurance certificate. Financial coverage for the IRH must be ensured for defective products marketed in Israel and injuries caused to product users in Israel.

Question: How do you calculate the annual fee for your IRH service?
Answer: Our annual fee depends mainly on product risk and estimated sales.

Question: Does BioReg Services have a warehouse for medical devices?
Answer: We don’t have a warehouse, but we work with reliable warehouses and can include this service in our offer.

Question: Could BioReg act as a distributor of our products?
Answer: We don’t usually distribute products, but we can identify reliable distributors and include this activity in our offer.

Question: Will BioReg Services’ name and address be on our device label?
Answer: BioReg Services’ name and address are mandatory only on labels of medical devices not intended for professional use (lay-use products).

Question: The manufacturer asked: We always advise users of what the device is indicated for and do not advise using the device outside of that indication for off-label use. Is it enough to sign an agreement with the product distributors that states, among other things, that if they use it off-label and an event occurs, we, as a manufacturer, are not liable?

Answer: If you know that the product will be used off-label, then your responsibility would be to change related intended use, labeling, or IFU. In other words, if a new intended use is created by professional users and you know about it, you must provide adequate labeling. In addition, such off-labels may fall under “reasonably foreseeable misuse” and should be covered through risk management. You could also review Team-NB-PositionPaper on Off-Label Use (2022).

Question: How can we contact the Israel Medical Device Department?

Answer: For correspondence, you can use the following email address: call.habriut@moh.health.gov.il. Also, you can call (from Israel)  *5400 (Call HaBriuth) or 08-6241010 from 8 AM to 6 PM

BioReg Services

We can guide you through the Israeli Medical Device Registration process and be your Israel Registration Holder. Don’t hesitate to contact us if you need any assistance with Medical Device registration, IRH service, or any other services. We also provide Trainings & Education for the companies.