TS03 Inc Trust Units TSTIF

RE:RE:RE:RE:equiopment audit

[okdogs]

Clam down.  Relax.   The post about medical recalls doesn't mean that devices will be realled.  If one reads the Health Canada bulletin, Health Canada wants to ensuring a manufacturers/supplier has recall procedures in place so that if necessary notices can be sent to all owners of the particular device advising them that a particular device has been recalled.  The following is a quote from the last page of Health Canada's bulletin:

"Not all medical devices recall requirements apply to all companies working with medical devices. The requirements to maintain distribution records under [sections] 52-56 [of the Medical Devices Regulation] and to have a recall procedure under 58(b) of the MDR (Part 1) apply to manufacturers, importers and distributors. Recall reporting requirements under sections 64 and 65 apply only to manufacturers and importers."

The new guide is also more focused on the process and responsibilities related to device recalls, whereas the previous version was more technical in nature, focusing on the individual sections of the MDR and their interpretation.

The new guide also includes additional appendices featuring flow charts and checklists for conducting recalls and maintaining distribution records.