Registration of Medical Devices

Before starting to market a medical device in Israel, there is a need to undergo a registration process at the Ministry of Health to check its safety and quality and at the end of this process a marketing approval may be obtained. The registration and monitoring activities continue to accompany the medical device even after the Ministry of Health approval for its marketing has been obtained and during its entire marketing period (life cycle) in Israel.

Our main goal is to assist you to successfully surpass all obstacles leading up to receiving an approval from the Ministry of Health for marketing your medical device. Emphasis is placed on quality performance of regulatory activities prior to the submission requesting registration, submitting a request according to the Ministry of Health standards, organized monitoring throughout the evaluation process by the medical device unit in the Ministry of Health, to ensure quick registration in the National Medicine Registry of the state of Israel.

In addition, BLAU Pharmaceutical Services will enable you to focus on the challenge of successful marketing of your medical device by giving a comprehensive response to a variety of regulatory challenges during its lifecycle.

And in 7 words…. You will receive even more from us!

The medical device unit is the central body in the Ministry of Health that deals with medical device registration in Israel. Its activity is regulated by procedures that are updated from time to time in addition to requirements of importers and manufacturers. The field of registration of medical devices has recently been undergoing major changes internationally and in Israel in particular. You, the importers or manufacturers of medical devices face difficult decisions when you are required to deal with questions such as:

• What are the requirements of the registration holder / importer / medical device manufacturer?
• What are the ways to expedite receiving an approval from the Ministry of Health for a new medical device, for registration renewal and for any variation of the registration conditions?
• How do you achieve effective communication with the medical device unit of the Ministry of Health?
• How do you deal with the new guidelines regarding medical devices in Israel, Europe, USA?
• Should you register the product as a medical device, medicine or cosmetic?
• When should you launch the medical device? What is the time frame required to receive approval to register of a new medical device?
• How does the CEO’s circular of the Ministry of Health affect the considerations for marketing/importing/manufacturing a medical device?
• What are the unique requirements required from the registration holder for a medical device intended for patients such as: leaflets, packages
• Under what conditions may a onetime import permit be obtained?
• When is it required to split the registration file of a new medical device, especially when requesting to renewal of a medical device license?
• How can you efficiently monitor the safety of medical devices after obtaining a marketing approval from the Ministry of Health?

• Preparing and submitting requests for registration of a medical device, registration renewal (license extension) of a medical device, and variations of the registration conditions in Israel, Europe and the USA, including preparation of the CE file.
• Efficient monitoring throughout the evaluation process at the Ministry of Health up to obtaining the approval.
• Professional medicinal translation to Hebrew– English- Arabic- Russian.
• Graphic design and printing of leaflets, packages, labels.Read more…
• Obtaining a onetime import permit and an importing certificate
• Continuous or temporary management of the registration field according to your needs.
• Choosing a strategy suitable for the registration of a medical device in Israel and internationally.
• Training the company’s management team regarding the regulatory aspects of the medical device regulatory field
• Updating the management regarding changes in the legislation and the guidelines of the medical device unit.
• Obtaining a certificate for exporting a medical device.
• Support and preparation for certification for the ISO 9001 quality standard and ISO 13485.

In conclusion, due to the professionalism, the vast experience and the excellent working relations with the authorities, our company’s customers have expanded the quantity of medical devices that they market, which has led to growth in their business activities in Israel and abroad.