Attorney Gil Nadel, Gilad Paz
Many goods are subject to strict regulations in import or export, requiring the presentation of certifications and licensing from various authorities (the Ministries of communication, health, agriculture, the standards institute, etc.)
In importing, the main legislative factor which regularizes the regulations is the free import decree, which notes, according to tax purpose classifications, the necessary certification required for the import of all types of goods.
As part of the process for regulating and regularizing, the Knesset has tried over the past few years, to legislate new laws, which address a specific topic and which fully regularize the regulations regarding a specific type of goods. One noteworthy example is the law for the supervision of security exports.
In May 2012 the Knessest approved a new law, called the Medical Equipment Law, 2012, whose main purpose is to determine the complete set of regulations for the import, sale, supply and marketing of medical equipment (not medication) to Israel and in Israel.
Medical equipment for which this law applies includes;
(1) An instrument used in medical treatments, and any instrument or computer software necessary for operating said instrument; for this purpose, "an instrument"- includes an appliance, chemical substance, biological product or biotechnological product;
(2) Contact lenses
(3) An electric instrument that emits ionizing radiation or non-ionizing radiation used in cosmetic treatments;
The law stipulates the import, marketing or sale of medical equipment in registering this equipment in the Ministry of Health, and grants facilitation for medical equipment that does not require registry, such as elastic bands, dental floss, bandaging materials, condoms and more.
Regarding medical equipment that was approved for use in "recognized countries" (the US, Canada, the UK, Belgium, Germany, Denmark, Norway, Australia and New Zealand), the law allows for this equipment to be almost automatically registered, also in Israel.
The law's explanatory remarks clarify that some of the medical equipment was required to meet the official standards of the Standards Institute, while others were required to be registered as per the People's Health Ordinance (special medical instruments), but there was no single law that fully regularized the issue of medical equipment, and importers of medical equipment had often dragged themselves between various authorities resulting in needless bureaucracy.
The law notes that since the use of medical equipment, such as medication, involves a certain amount of risk, it is certainly legitimate to stipulate its use in receiving advance certification.
As noted in the explanatory remarks, before this law was legislated, the regulation of medical equipment was regularized via various legislative means, among them the free import decree (legislated by virtue of the import and export directive).
Various customs tariffs that are applicable to medical equipment, as per the classification, stipulate the import of this equipment upon receiving certification from the Unit for Medical Appliances and Instruments of the Ministry of Health.
The new law is meant to fully regularize the process by which a certificate is received from the Unit for Medical Appliances and Instruments for the purpose of importing medical equipment in correspondence with the free import decree, and therefore there are no conflicting issues between the new law and the free import decree. Instead, this law fully complies with the decree.
The biggest boon of this law, as mentioned above, is the almost automatic registry of medical equipment when that equipment has already been approved for use in recognized countries.
A certain issue that is not fully addressed in the new law is the requirement for the medical equipment to meets standards. The law's current version, the medical equipment law does not address with this issue. There are many customs tariffs within the free import decree that require medical equipment to meet an official standard as a condition for being imported, aside from receiving certification from the Unit for Appliances and Instruments.
The new law allows for registry if there is such a registry in a foreign country, but it does not dismiss the need for meting the official standard in such a case.
This subject was discussed at the Knessest committee before the law was approved, and it was noted that clause 2(c)(2) of the free import decree allows the Minister of Industry, Trade and Labor, to exempt, under certain circumstances, imported equipment from receiving a standard certification, and this was furthermore anchored in regulation 2.6 of the Director General of the Industry, Trade and Labor Ministry, labeled: "Granting exemption in accordance with clause 2(c)(2) of the free trade decree", thereby allowing medical equipment the opportunity to be granted such an exemption as per the regulation.
In the bottom line, the medical equipment law was designed, in practice, to provide some order to the sensitive field of medical equipment importation to Israel by means of regularizing it through primary legislation and in full.
The law aims at granting one authority- the Ministry of Health- the power to supervise over the import and marketing of medical equipment.
The law brings numerous, significant facilitations for importers of this field, which have the potential to greatly simplify the procedure for the importation and licensing of this type of equipment to Israel, but in our opinion, not there are still some bureaucratic difficulties that have yet to be addressed in this field, primarily the issue of meeting the standardization requirements.
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