May 9, 2014

Health Canada: DuPont Packaging Material Changes to Impact Sterile Medical Device Manufacturers

Medical device manufacturers licensed to sell their products in Canada have been notified that recent changes in the production process of a widely used device packaging material will require some firms to file significant change amendments with Health Canada, Emergo Group has learned. Health Canada’s notice to Medical Device License (MDL) holders relates to recent manufacturing changes implemented by DuPont for that firm’s Tyvek® packaging material; Tyvek is used extensively for sterile medical device packaging.
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
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
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
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
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
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
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
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.)
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

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