The Knesset on Monday approved the draft law initiated by the Ministry of Health dealing with oversight of the medical equipment market, which has expanded considerably in recent years, and which is very highly developed in Israel.
This law is another step forward in promotion of public health in Israel.
A variety of medical equipment serves in a broad spectrum of medical procedures. To date, Israeli law has been devoid of any legislation on a supervisory mechanism over medical equipment from the aspects of public and patient safety, and the Ministry of Health’s supervision of this market has relied on Director General circulars and procedures only.
The law for the first time codifies the authority of the Ministry of Health to supervise the manufacture, marketing and use of medical equipment in Israel and compels all of the medical equipment in Israel to meet uniform standards, as is the practice worldwide, in order to safeguard the quality of the equipment and the safety of its users.
The draft law was published in 2007, was debated in the previous parliamentary session, where it passed the first reading and initial discussion in the Labor, Welfare and Health Committee.
At the start of the current sitting, the draft law underwent a ‘continuity law’, intending to continue the legislative process and bring it to completion. In January 2012, the subcommittee for the medical equipment law was set up, chaired by MK Professor Arie Eldad, who made a significant contribution to the profound and intensive debate of the legal directives, to prepare the law for the second and third readings.
The Director General of the Ministry of Health, Prof. Roni Gamzu, said: “From now on, the processes of registration, evaluation, control and management of this area in the Ministry of Health and in the health institutions, will ensure higher quality and standards for the sake of public health and the quality of medical treatment.”
The Ministry of Health wishes to thank prof, Eldad and the members of the Labor, Welfare and Health Committee for the extensive work they invested in the subcommittee.
In preparation for the law coming into effect, the Ministry of Health intends to reinforce its supervision and registration network for medical equipment in Israel, to add manpower to the units and to strengthen its capabilities in this area.