Monthly Archives: March 2016

Medical Device Single Audit Program (MDSAP) Update

By |March 30th, 2016|

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 […]

Conditional registrations for pesticides

By |March 28th, 2016|

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, […]

Updated Site License (SL) Guidance Document

By |March 23rd, 2016|

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 […]

Reminder to Generic Drug Manufacturers

By |March 7th, 2016|

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 […]