The ministry of health wishes to inform the public the latest decision concerning the EMS devices
Further to previous announcements of the Ministry of Health regarding EMS devices, the Ministry wishes to inform the public the latest decision concerning the option of registration this device in the Register of Medical Equipment, as well as to warn the public concerning health hazards involved in uncontrolled the use of this equipment.
The application of EMS device at the Ministry of Health as part of the medical equipment registration system will only be possible for a device intended to be used for medical treatment.
Applications for registration of EMS devices as medical equipment, reviewing the option to register them at the Ministry, as well as the marketing and the usage of registered devices, will be conducted in accordance with the rules applicable in this context, as for any other product that may be registered as medical equipment. As part of this, among others things, the applicant is required to provide certificate of FDA and / or health authority or other authorizing organization recognized by the Ministry of Health for this purpose. Accordingly, the use of EMS devices registered as a medical equipment must be under the registration’s terms and indications, including usage for medical use only, by medical professionals such as physiotherapists and doctors. Devices registered as medical equipment (for the purposes of medical treatment) must not be used for any other non-medical purpose, including fitness training and similar activities and in gyms.
On the other hand, EMS devices not intended for medical use can be used for various purposes, including fitness training and similar purposes. These devices will not be registered at the medical equipment registry at the Ministry of Health.
Alongside the above, the Ministry of Health warns against health hazards involved in the use of EMS devices, including devices intended for non-medical use. This device is used for simultaneous stimulation of large groups of muscles, and naturally can damage health.
The safety of this device for fitness training or similar activities depends on various aspects, including using it in accordance with training program, in a controlled manner that is adjusted to the user’s abilities, sensitivities and medical fitness, which is true, to some extent, to other fitness training methods as well.
In any case, registration of EMS device in the medical device registry of the Health Ministry, or confirmation of this registration as stated, should not be considered as referring to using the device for non-medical purposes, including for the purposes of fitness training and similar activities.
Accordingly, EMS devices which have been registered as medical equipment should not be presented as having received the approval of the Ministry of Health to use for non-medical purposes, and the public must not be misled on the matter.
It should be noted that re-examination of the issue by the ministry and the publication of this notice were made in light of the pertinent considerations in order to reflect to the public the Ministry’s position, and out of commitment to the interests of public health.
At the end of the day, each party should consider their actions in accordance with their understanding and discretion, and subject to any law.
For the avoidance of any doubt, it is clarified that this statement should not be interpreted as a recommendation to use the device for any purpose.
This announcement replaces the previous announcement published regarding EMS devices