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.
Feb 20, 2013

MEDEC-Analyse: Längere Prüfzeiten bei Health Canada

Eine Analyse der Daten von Health Canada durch den Berufsverband der Medizinproduktebranche in Kanada, MEDEC, hat längere Prüfzeiten und Mängel bei der Vorprüfung von
Feb 18, 2013

MEDEC Analysis: Increased Review Times at Health Canada

An analysis Health Canada data by Canadian medical device trade association MEDEC has found increasing review times and screening deficiencies for
Jul 9, 2012

Final Guidance on Class III, IV Device Licensing from Health Canada

Health Canada has released final guidance on supporting evidence requirements for Class III and Class IVC medical device license applications. The guidance specifies scientific information requirements for manufacturers submitting Class III and Class IV device license applications, excluding makers of Class III and IV IVD products. (Health Canada plans separate updated guidance on higher-risk IVDs in the future.)
May 3, 2012

MEDEC: Health Canada Application Volumes on the Decline

The number of Medical Device License (MDL) and amendment applications to Health Canada’s Medical Devices Bureau (MDB) has declined over the first quarter of 2012, according to Canadian medica
Apr 16, 2012

Health Canada Amends Lists of Medical Device Standards

Health Canada has announced changes to its list of recognized list of medical device
Oct 26, 2011

HC Extends Premarket Review E-Submission Program to Class III Devices

Starting November 1, 2011, Health Canada will extend a pilot program requiring both p
Jul 25, 2011

New Guidance from Health Canada on Medical Device License Renewal

Health Canada has published new guidance for manufacturers of Class II, III and IV medical dev
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