May 6, 2019

Canadian regulators issue recommendations for 3D-printed Medical Device License applicants

EMERGO BY UL SUMMARY OF KEY POINTS: Health Canada issues guidance for 3D-printed medical device manufacturers for what to include in MDL applications; Guidance covers data to include for design and manufacturing, material controls, labeling and related issues; Guidance applies to Class III and IV 3D-printed implantable devices.
Jun 10, 2011

Ontario Government Backs Off Requiring ESA Registration for Some Medical Device Makers

Last month, Ontario’s Ministry of Consumer Services issued a proposed amendment to the province’s product...
Jun 10, 2011

Health Canada’s Surveillance Process Found Lacking

Canada’s Office of the Auditor General has found Health Canada’s medical device surveillance and inspection...
May 6, 2011

Licensing Changes in Place at Health Canada

Health Canada has announced several changes to its licensing processes over the past several weeks, some of which have been
Mar 28, 2011

Health Canada Moving to Flat-Fee Structure April 1st

Citing rising costs of performing medical device and pharmaceutical regulatory activities in Canada, Health Canada has announced user fee increases—some of them substantial—for medical device license
Feb 2, 2011

Canada’s MDB Struggled to Meet Market Authorization Timelines in 2010

According to MEDEC, the Canadian medical device industry trade association, Health Canada’s Medical Devices Bureau (MDB) faced a persistent backlog last year when it came to processing
Jan 27, 2011

HC Clarifies Significant Change Guidance

Health Canada has published new guidance defining when manufacturers’ altering of their Class III and Class IV devices constitutes “significant change,” affecting
Dec 13, 2010

HC Makes Some Allowances for Paperless Medical Device Labeling

Health Canada has issued a new interpretation of Canada’s
Dec 10, 2010

Mexican Market Entry Just Got Easier

Medical devices and IVD products able to pass muster with the US FDA and Health Canada may now enjoy de facto access to Mexico as well thanks to recent regulatory reforms. The Mexican Health Author
Dec 8, 2010

HC Sets Compliance Deadlines for Revised Software Requirements

Software manufacturers whose products fall under Health Canada’s medical device classification system have until February or September 2011 to comply with new requirements set forth by the regulator.