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New Evidence Required for Light Emitting 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 with laser, intense pulsed light (IPL), or light emitting diode (LED) energy sources.

The new evidence requirements impact class III and IV […]

By |April 4th, 2016|Announcement, Medical Devices|0 Comments

Changes to the Non-prescription Drug Monograph Attestation Process

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 with the monograph.

During the review of DINF applications special attention will be given to the acceptability of medicinal and non-medicinal ingredient […]

By |April 4th, 2016|Announcement, Drugs|0 Comments

Medical Device Single Audit Program (MDSAP) Update

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 will be the sole mechanism for demonstrating compliance with the quality management system (QMS) requirements of the Medical Device Regulations.

The […]

By |March 30th, 2016|Audits, Medical Devices|0 Comments

Conditional registrations for pesticides

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 information is needed. In this cases, the pesticide is approved prior to the review of additional information.

In future, […]

By |March 28th, 2016|Announcement, Uncategorized|0 Comments

Updated Site License (SL) Guidance Document

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 the SL review process include:

  • SL renewals will be refused for companies who have not conducted activities in […]
By |March 23rd, 2016|Natural Health Products|0 Comments

Reminder to Generic Drug Manufacturers

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 monthly basis, Health Canada posts the Product Monograph Brand Safety Updates table. This table displays updates and/or new […]

By |March 7th, 2016|Drugs|0 Comments

Handling Medical Devices Establishment License Audit

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 existing clients.

The first step of the project was to conduct an onsite assessment. We […]

By |February 24th, 2016|Audits, Medical Devices|0 Comments

DSA Travels to Mexico

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 site reviewing master production records, stability, validation and other […]

By |February 18th, 2016|Audits|0 Comments

Change to Ibuprofen listing on the Prescription Drug List

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 of this change is six months from the date of Health Canada’s notice (February […]

By |February 10th, 2016|Drugs|0 Comments

Updates to DEL Applications & GMP Evidence Requirements for APIs

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 the way API submissions are processed and changes to the GMP evidence requirements of […]

By |February 5th, 2016|Announcement, Drugs|0 Comments