New Evidence Required for Light Emitting Medical Devices

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...

Changes to the Non-prescription Drug Monograph Attestation Process

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...

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...

Handling Medical Devices Establishment License Audit

by dsaadmin | Audits, Medical Devices

DSA Consultants was recently hired by a local Mississauga firm to handle their Medical Devices Establishment License Audit with Health Canada. The firm is currently licensed as an Importer of Medical Devices into Canada. They were referred to DSA by one of our...

DSA Travels to Mexico

by dsaadmin | Audits

Recently, one of our Senior Quality Consultants was tasked with an audit of a contract manufacturing site in Mexico. The purpose of the audit was to help prepare the firm for an eventual audit by Health Canada. Our Senior Quality Consultant spent 5 days at the audit...

Change to Ibuprofen listing on the Prescription Drug List

by dsaadmin | Drugs

Health Canada has announced that certain uses of Ibuprofen will be changed to nonprescription status by amending the Prescription Drug List (PDL). This change only impacts Ibuporfen for human use; the current Veterinary listing will remain the same. The effective date...

Updates to DEL Applications & GMP Evidence Requirements for APIs

by dsaadmin | Announcement, Drugs

The Active Pharmaceutical Ingredient (API) regulations came into force on November 8, 2013. After a three year transition, November 8, 2016 will mark the full implementation of the Regulations. Health Canada has posted several updates on changes that have been made to...