Ministry of Health has taken actions to regulate the use of EMS devices
Following the previous notice of the Ministry of Health on the subject of EMS devices, the Ministry has taken actions to regulate their use. The outline for regulation was formed with careful attention to public health considerations.
- The Ministry of Health will register EMS (electric muscle stimulation) devices under the following conditions:
The devices that are approved for import, marketing and EMS physical training will only be devices approved by the FDA and/or by the Canadian authorities and/or compliant with the European standards required for operating these devices and/or with TGA (Australian authorities) approval
- The devices that are approved for import, marketing and EMS physical training will also be approved by the Standards Institution of Israel and/or have received Ministry of Economy approval (standard exemption)
- The devices are to be registered at the Ministry of Health through one of the following tracks:
- Registration as a medical EMS device: To be registered according to the common rules for devices of its type (i.e. as all medical equipment in Israel is registered)
- Registration as an EMS device for physical training (without a medical indication): To be registered according to the following rules:
- An EMS device for physical training and personal and private use will be approved for use by a customer after the customer received 10 hours of training by the importer or an agent thereof. Such a device will be accompanied by operation instructions in Hebrew and Arabic.
- An EMS device for physical training that will be sold for commercial use will be approved for operation according to the following rules:
A) The device’s operator will be a qualified fitness gym coach as defined in the Sport Law who has also been authorized by the manufacturer or a representative thereof to conduct physical training using an EMS device intended for this purpose, the coach’s training including at least 30 hours’ professional training of which 10 hours at least are to be supervision hours by a qualified coach.
B) The certification will include passing theoretical and practical final examinations as defined by the importers and according to the relevant devices and in a manner that will not be less than the requirements of the manufacturer.
It is the position of the Ministry that uncontrolled, unregulated use may cause medical damage and endanger health.