Amendment to the Enforcement Order of Industrial Safety and Health Act and related ordinances about the substances subject to labelling and notice; (1 page(s), in English), (15 page(s), in English), (17 page(s), in English)

First amendment to the Mandatory Standard SI 60601 part 2.6. This amendment adopts AMD 2: 2022-09 of the International Standard IEC 60601-2- 6:2012 with a few additional national deviations to the standard's Hebrew section. Both the standard without this amendment and the amended standard will apply from the entry into force of this proposed amendment during a transition period of 4 years. During this time, products may be tested according to both editions.

Draft amendments to the Rules for marketing authorization and assessment of medicinal products for human use; (24 page(s), in Russian)