EMR Registration Process – medical devices and accessories
The Department of Medical Devices belongs to the Ministry of Health, and is responsible for granting import and sale permits for such equipment in Israel, and it is therefore necessary to register equipment for the launch of medical equipment and accessories in Israel.
Medical equipment is defined as an “instrument, accessory, software, chemical, biological or biotechnological product used in the treatment or required for the operation of a device or accessory used for the treatment and is not intended primarily to act on the human body as a medicinal device.” The Medical Center’s definitions include, among other things, dialysis concentrates, lubricants and gels intended for the operation of medical devices, and many types of washing solutions, alcohol-soaked dressing materials, etc.
The EMR registration process at the Ministry of Health includes:
- Letter of registration from the Medical Center, previous medical certificate
- Regulatory approvals such as FDA, CE, Declaration of Conformity
- Import documents
- Business License
- Importer declaration
- Company incorporation certificate
- Quality Management System ISO 9001 or GMP of Importer
- Manufacturer Statement
- ISO13485 or GMP quality management system of production sites
- World sales
Technical Documents :
- Technical data
- Risk Management
- Product safety
- Clinical data
- (EDQM) The European Directorate for the Quality of Medicines & HealthCare
- Chemical analysis and more
- The labels
- User manual
- recommendation letters
Topics to fill in the form:
- A general description of the device based on some of its characteristics (whether it is electric, implanted in the body, emits radiation, contains any medicine, whether it contains animal material, etc.)
- Details on the sterility and degree of sterilization of the device and the need for sterilization processes when using it
- Details about its operation, service and maintenance
- Certificates for an accessory or device from health authorities are recognized worldwide
- Details of product sales in Israel and worldwide
- Details on inclusion of the product in the health basket in Israel or in other countries
It should be noted that at the time of initial submission for the purpose of registration of the Medical Center, there is no need to attach samples of the product, unless necessary.
On the face of it, the initial application process is simple, but the procedures are very strict, submitting forms with incomplete details or submitting an incorrect form may delay the process for a long period of time. Due to the large number of procedures, there is a need to familiarize ourselves with the regulatory processes and procedures of the Ministry of Health in order to effectively complete registration. Therefore, our recommendation is to carry out the procedure with close professional assistance.
The Ministry of Health has various types of AMR registrations, among them:
- Annual approval according to a free import order. A certificate that must be requested and received each year for the purpose of continuing the importation of a medical product or accessory.
- CFS – certificate of free sale. Confirmation that the product is freely sold in the country of origin. The certificate is required for anyone who produces in Israel and intends to market its products abroad.
- One-time approval (import). Designed to synchronize the registration process with customs authorities. Applications must be submitted with the appropriate documents according to the instructions of the Ministry of Health and Customs.
Our services include:
- Collecting, arranging and processing the materials according to the requirements of the medical officer, preparing the file, filing the file.
- Registration / renewal of medical equipment, annual import approval, one-time import approval, preparation for ISO 13485 and ISO 9001 tests
- Meetings at the Ministry of Health and close accompaniment.
- A long-standing acquaintance with the Medical Unit in the Ministry of Health