You decided to import products that are defined as medical device and from now on you will be called "importer of medical device". Now you must know the Ministry of Health,the customs and the guidelines for import, registration and marketing of medical device. Good luck!
A business at its early stages is challenging, especially if you also have to import medical device.
So, where do you begin?
You deliberated and decided to import products which are defined as medical device, and from now on you will be referred to as a medical device importer. Now you have to familiarize yourself with the Ministry of Health, Customs and the instructions for importing, registering and marketing medical device. For this reason, I simplified and summarized the stages in the process for you:
The first stage – in order for you to be able to market medical accessories and devices in Israel, you will be required to register them in the Ministry of Health at the Department for Medical Devices.
Before you sign an agreement with the manufacturer, and before you contact us to register you as an importer, we recommend that you ensure the manufacturer has an approval by a regulator recognized by the state of Israel (CE, Health Canada, TGA, FDA) as well as an ISO 13485 quality certificate (unless the manufacturer is in the USA).
If the manufacturer has the basic documents, you can advance.
The next stage will be to ensure you have ISO 9001 and a business licenses at the designated storage location.
When these are available, it is possible to begin the process of submitting the request for registration of medical devices at the Ministry of Health. As part of this process we approach the manufacturer and you, for the purpose of concentrating documents and preparing matching declarations. At the end of gathering the documents and forming the case, we will submit a request for registration of medical devices at the Ministry of Health. The period of time for receiving an approval for the registration of a medical device is at least 120 days from the day of receiving the request… patience. The meaning is that using the product is permitted only after receiving the registration approval (the Law of Medical Devices contains facilitations in certain cases for uses prior to receiving the approval).
Simultaneous to the registration process, you should already contact a customs broker to engage with, in order to begin importing as soon as you receive the approval.
In order to enter medical device via Customs to Israel, you must receive a medical device importing approval. Here, too, we will approach the Ministry of Health in order to receive an importing approval.
There are 2 types of importing approvals:
One-time importing approval – is as the name suggests. A one-time importing approval in exchange for a specific invoice. The purpose of this approval is to enable importing in cases where the Ministry of Health will not approve long-term importing (also known as a periodic importing approval).
Periodic importing approval – an approval given after receiving the medical device registration approval. Its purpose is to enable entering medical devices specified in the periodic importing approval according to a free importing order, without the need for a one-time importing approval any time goods is brought into Israel.
The saga does not end here! The medical device approval and the period importing approval are limited in time and given until a date specified on the approval. Note that you must renew the approval several months before the approval expires. In addition, as part of distributing the products to the user, you may have to manage organized registration of who receives what (depends of the products’ level of risk). It is worth asking us, according to the product, what is required of you at the stage of marketing and distribution.
Have no fear. At the end (probably) you will be able to market the products in Israel, but at the initial point, and certainly if you want to do this the fast, easy and most efficient way suitable for you, we recommend for you not to be shy and consult us all along the way. Our professional team could assist you and guide you on the regulation processes which are right for you.
It is important, throughout the entire process, to maintain contact with the Ministry of Health, ensure the request is being handled, follow the request’s status and promote it until receiving the final approval.