Adv. Moshe Kahn
Background
The Medical Equipment Law, 5772-2012 was designed to regulate the use, import, marketing, and distribution of medical equipment in Israel. Medical equipment is an instrument (chemical, biological, biotechnological, software, etc.) used in medical treatments, except for medication. It is a very broad definition, beginning with bandages, surgical tools, and syringes and up to complex machines such as ultrasound and MRI.
AMAR - The unit for medical devices and accessories at the Ministry of Health is responsible for registering and supervising the medical equipment in Israel.
Prior to regulating the import, use, and distribution of medicine by law[1], before the enactment of the Medical Equipment Law, there was no express legislation governing the supervision of medical equipment in Israel.
Prior to the enactment of the Medical Equipment Law, only governmental medical institutions were required, in a circular published by the Ministry of Health, to use only medical equipment that was registered in the Register and supervised by the AMAR. On the other hand, hundreds of private medical institutions in Israel could voluntarily elect whether or not to use medical equipment that is not registered with AMAR.
Regarding importers and marketers, some of the medical equipment did in fact require the approval of the Standards Institution of Israel, and some were prohibited from being imported without the approval of the Israeli Ministry of Health, however, prior to the enactment of the Medical Equipment Law, some of the medical equipment could be manufactured, marketed and distributed in Israel, without it being registered or approved by the Ministry of Health.
Medical Equipment Law, 5772-2012
The Medical Equipment Law imposes a criminal prohibition on manufacturing, importing, marketing, and using medical equipment which has not been registered in the Register of AMAR, except in exceptional cases and with the approval of the Israeli Ministry of Health[2]. Violators of the law face imprisonment of up to one year as well as fines (and in exceptional cases of real danger to the public health, imprisonment of up to three years and a fine of up to one million one hundred and thirty thousand NIS).
In addition, the Medical Equipment Law provides that in order to be registered in the Israeli Register, the medical equipment needs to comply with any of the following two conditions: (a) AMAR has examined and approved its effectiveness and quality, or (b) the AMAR registration supervisor is satisfied that the equipment is permitted to be marketed in a Western recognized country[3] and is being marketed there in practice.
This last condition is important for Israeli importers of medical equipment, since it may facilitate their activities significantly. In the proposed Medical Equipment Regulations, it has been proposed that the equipment will be registered in the Register by no later than 120 days from the date of submitting the application.
Furthermore, the Medical Equipment Law provides that the Israeli Minister of Industry, Trade, and Labor may exempt an importer from the requirement of complying with the required standards if he believes that the equipment complies with the international standards. The Minister of Health may also order an exemption of certain types of equipment from registration in the Register if he is satisfied that they do not endanger public health.
In addition, the Medical Equipment Law provides that during registration, the supervisor of the Ministry of Health may subject the use of the medical equipment to certain conditions which shall be specified, as he may deem fit. Thus, for example, the supervisor may prohibit the use of medical equipment that is presented to him without a physician’s approval, he may require the importer to carry out a sample testing of the equipment, he may give orders regarding the manner of its storage and delivery, he may require publication of an information leaflet for the user, and so forth.
The Medical Equipment Law prescribes the appointment of inspectors to ensure the enforcement of its provisions. The registry supervisor may delete equipment from the Register if the registered owner of the equipment has breached the terms given to him at the time of registration.
In addition, AMAR may delete from the Register equipment that endangers the public health or equipment which has ceased to comply with the quality standards as determined at the time of registration or whose marketing license in the recognized foreign country has expired. Nevertheless, the Law enables to continue to market (but not to import) and to use the medical equipment whose registration has been canceled, expired, or deleted for an additional period of two years, unless otherwise expressly determined by the Manager of the Ministry of Health.
The Medical Equipment Regulations intend to impose several duties on the registered owner. These include the duty to carry out monitoring and auditing of the registered medical equipment, the duty to report any case of shortcoming or new medical information that is discovered, the preparation of periodic reports and submission thereof to the AMAR department, etc.
The Medical Equipment Law was passed by the Knesset in May 2012 and is expected to come into force, gradually, in 2013. The Law is expected to change the medical equipment market in Israel. To all those concerned, it is strongly recommended, therefore, to study the law, know it thoroughly, and prepare accordingly.
September 2012
* Adv. Moshe Kahn specializes in Business Law. He is licensed to practice law both in Israel and in the U.S. and is the founder of the Moshe Kahn Advocates law firm in Tel Aviv
[1] The Pharmacists Ordinance [New Version], 5741 – 1981; it should be noted that usually, the Medical Equipment Law will not apply to medical technology as such.
[2] Except for a number of equipment listed in the Second Appendix to the Law which is exempt from registration – bandages, cotton wool, feminine hygiene products, etc.
[3] The First Appendix of the Medical Equipment Law lists the Recognized Countries.
