Medical Devices

Intent to Reclassify Disinfectants and Sterilants for Use on Medical Devices

By |October 18th, 2016|

Currently, disinfectants and sterilants that are intended for use on medical devices are regulated as drugs under the Food and Drug Regulations. However, Health Canada has communicated that they intend to reclassify these products as medical devices which means that disinfectants and sterilants used on medical devices would be subject to the requirements of the […]

Transition to ISO 13485:2016

By |October 4th, 2016|

ISO will withdraw ISO 13485:2003 on March 1, 2019, three years after the publication of ISO 13485:2016.

All Canadian and Foreign manufacturers of class II, III, and IV medical devices holding licences or applying for new or amended licences must complete the transition to ISO 13485:2016 by March 1, 2019.

Manufacturers which have not transitioned to ISO […]

Decorative Contact Lenses Classification

By |June 30th, 2016|

As of July 16, 2016, decorative contact lenses will be regulated as Class II medical devices in Canada.

Manufacturers will be required to obtain a medical device licence before advertising or selling decorative contact lenses.

Health Canada will be implementing a 12-month transition period to allow manufacturers of decorative contact lenses to obtain their Class II medical device licence.

After […]

Commercial Reprocessing of Medical Devices Originally Labelled for Single Use

By |May 11th, 2016|

Single-use medical devices are those labelled by their manufacturers to be used only once. For many years hospitals have been reprocessing some medical devices originally labelled for single use for cost savings. Reprocessing includes cleaning, sterilising and disinfecting.

However more and more hospitals are outsourcing reprocessing to outside companies. Although hospitals will continue to be permitted […]

New Evidence Required for Light Emitting Medical Devices

By |April 4th, 2016|

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 […]

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 […]

Handling Medical Devices Establishment License Audit

By |February 24th, 2016|

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 […]