Australia’s Therapeutic Goods Administration said in a recent notice that it has received queries from a number of organizations regarding the re-use of face masks and gowns during the COVID-19 pandemic, noting that any reuse must be preceded by reprocessing. Reprocessing may entail cleaning along with disinfection or re-sterilization, and TGA noted that any reprocessing of a medical device may make the reprocessing entity a device manufacturer for the purposes of the regulation.

Health Canada said in a May 26 notice that a pilot program for medical device regulatory enrollment processes was a “generally positive” experience for participants and that the pilot will as a result be followed by a more extensive version. The agency said the scope of the pilot has now been expanded to include private labels, although investigational testing applications are not yet eligible for the program. Companies that take part in this program must be using the table of contents format published by the International Medical Device Regulators Forum, however.

No Comments