Israel Devices Registration Summary

This post presents an Israel Devices Registration Summary, a regulation already in force since April 2024.

For the first time, the New Israel Medical Device Law offers a “Declaration” route, where the submission is reviewed only by the Israel Registration Holder (IRH). No additional official regulatory approval is needed from the Israel Ministry of Health. Such a route exists only for low-risk Class I medical devices for product registration (initial registration). Since IRH for these devices is your only bridge to the market, you should look for an experienced Israeli regulatory consultant.

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

	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.

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: Does the manufacturer of a Class I medical device need to have 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: The manufacturer asked: We always advise the distributor 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 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 and your post-marketing clinical evaluation process.

Question: What would be considered a non-significant change according to Israel AMAR medical device regulation?

Answer: This should be assessed for each concrete case, but generally, we can say that the non-significant changes definition in Israel is based on the EU-MDR definition and would include (assuming the risk/benefit ratio of the device is not negatively affected) the following:

Change that doesn’t alter built-in control mechanism, operating principle
Replacement of a component with the same specifications
New supplier/producer of a material within the defined specifications
Security updates (e.g. cyber-security enhancements)
Updates/upgrades of operating systems, e.g., Microsoft Windows, iOS, and others

BioReg Services

BioReg is a regulatory consultancy and an Israeli Registration Holder (IRH) who can help you register and market medical devices in Israel. Don’t hesitate to contact us if you need any assistance with AMAR registration. IRH service or any other Regulatory Service

BioRegards,

Daniel

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Israel Devices Registration Summary