Proposed amendments to the "Regulations on Fees for Pharmaceutical Approvals, etc."; (10 page(s), in Korean)

Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing), (63 pages, available in English and French)

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.