Health Canada to Amend List of Recognized Standards for Medical Devices
Posted 12 September 2018 | By
Health Canada is seeking input on proposed changes to the current list of recognized standards for medical devices, including the removal of 20 standards and the addition of 15 new ones.
From biocompatibility and in vitro
diagnostics to manufacturing and sterilization, the standards are recognized by regulators worldwide. They were developed via the International Electrotechnical Commission and International Organization for Standardization, among others.
In addition to the proposals on removing and adding certain standards, Health Canada seeks to update 12 previous editions that have been superseded. These include IEC 60601-1-2:2014.
Health Canada intends to continue accepting declarations of conformity to IEC 60601-1-2:2007 - Ed 3.0 in support of premarket submissions until 31 December, the regulatory authority said
MEDEC— the national association of Canada’s medical technology companies— has “just begun consulting” with its members on their thoughts regarding the changes, Gerry Frenette, head of communication, told Focus.
It intends to comment before the 9 November deadline.
The regulatory authority issued draft guidance
Tuesday to aid in the review of the proposed changes to the Therapeutic Products Directorate’s list of standards prior to providing feedback.