Medical Device Single Audit Program (MDSAP) Update

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...

Conditional registrations for pesticides

by dsaadmin | Announcement, Uncategorized

As of June 1, 2016 Health Canada (HC) will no longer issue conditional registrations for pesticides. Currently conditional registrations may be granted to pesticide products when the scientific review determines that the risks of a pesticide are acceptable, but more...

Updated Site License (SL) Guidance Document

by dsaadmin | Natural Health Products

The Natural and Non-prescription Health Products Directorate (NNHPD) has posted an updated SL guidance document. Along with the updated guide the Quality Assurance Report (QAR) and Summary of Net Changes (SNC) forms have also been updated. Important changes to note to...

Reminder to Generic Drug Manufacturers

by dsaadmin | Drugs

Market authorization holders (MAH) of generic drug products regulated under Division 8 of the Food and Drug Regulations are required to file submissions to update their labelling to ensure consistency with that of the Canadian Reference Products (CRP) labeling. On a...