by dsaadmin | Medical Devices
Currently, disinfectants and sterilants that are intended for use on medical devices are regulated as drugs under the Food and Drug Regulations. However, Health Canada has communicated that they intend to reclassify these products as medical devices which means that...
by dsaadmin | Medical Devices
ISO will withdraw ISO 13485:2003 on March 1, 2019, three years after the publication of ISO 13485:2016. All Canadian and Foreign manufacturers of class II, III, and IV medical devices holding licences or applying for new or amended licences must complete the...
by dsaadmin | Medical Devices
As of July 16, 2016, decorative contact lenses will be regulated as Class II medical devices in Canada. Manufacturers will be required to obtain a medical device licence before advertising or selling decorative contact lenses. Health Canada will be...
by dsaadmin | Medical Devices
Single-use medical devices are those labelled by their manufacturers to be used only once. For many years hospitals have been reprocessing some medical devices originally labelled for single use for cost savings. Reprocessing includes cleaning, sterilising and...
by dsaadmin | Announcement, Medical Devices
Health Canada has announced that effective immediately evidence will be required to demonstrate that all hazards associated with thermal damage to the skin are eliminated or appropriately mitigated for light emitting medical devices. Affected devices include devices...
by dsaadmin | Audits, Medical Devices
The Medical Device Single Audit Program (MDSAP) Pilot will conclude December 31, 2016. MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. MDSAP...
