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 | Announcement, Drugs
All non-prescription Category IV Monograph product (DINF) applications must include the new monograph attestation form. Due to unfavorable results of the monograph attestation pilot, Health Canada has put in place processes to ensure that all DINF applications comply...
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...
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...
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...
