ISRAEL Law and Practice Contributed by: Lior Glassman, Matan Kovacs, Alexandra Cohen and Tamar Morag Sela, Reinhold Cohn Group
allowing them to be registered based solely on a declaration from the registration holder or the importer. This route applies only to devices that are already registered and marketed in recog- nised countries (including the USA, Canada, Australia and the UK, as well as EU member states such as France and Germany). Applica- tions must include a completed form, a signed declaration, regulatory certificates, and support- ing documents. No fees are required. Addition- ally, annual renewal declarations must be sub- mitted by October 1 of each year to maintain registration. In June 2024, a second guideline was introduced to enable fast track registration for Class II and in vitro diagnostic (IVD) medium-risk devices. This procedure applies to Class II, IIa, IIb, and IVD B/C devices that are already registered in recognised countries. The registration process under the guideline is simplified, requiring proof of marketing history (four to six months), regula- tory certificates, and a declaration from the reg- istration holder. Processing times vary, as new registrations for Class IIb and IVD C devices may take up to 60 days, whereas renewals may take up to ten days. There are no fees required. These two guidelines aim to streamline the registration process in Israel, ensuring that pre-approved medical devices can enter the market efficiently while regulatory oversight is maintained. 4.2 Regulatory Reliance Israel has embraced the concept of regulatory reliance, both for pharmaceuticals as well as for medical devices. Where pharmaceuticals are concerned, the reg- istration of a new pharmaceutical for the pur- poses of obtaining a market approval may only begin after it has been registered in other recog-
nised countries. The same is true for biosimilars and generics as well. Additionally, according to the Medical Device Law of 2012, the MoH may register a medical device even if the conditions outlined in the law are not fully met, provided that the device is reg- istered in a recognised country or authorised for marketing and actively marketed in that recog- nised country. Moreover, the Medical Devices Regulations (Registration of Medical Equipment in the Reg- ister and its Renewal) of 2013 set forth that – during the registration process – medical devic- es that are already registered or marketed in a recognised country do not require additional documentation such as risk analysis, clinical evaluation, clinical trial summaries, and expert opinions. If a device is equivalent to a device that is already registered in Israel or in a recog- nised country, it can follow the same simplified registration process. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices Manufacturing of Pharmaceuticals The manufacturing of pharmaceuticals is regu- lated by the Pharmacists Ordinance of 1981 and the Pharmacists Regulations (Preparations) of 1986, as well as by specific regulations relating to production conditions for preparation and by the MoH’s guidelines. Among other things: • the plant should be operated by skilled professionals, including a quality assurance
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