MDL

Health Canada Reclassifies Certain Disinfectants as Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Health Canada will begin regulating some disinfectants and sterilizing solutions including contact lens solution as medical devices.
  • Affected products are now considered Class II devices, but Health Canada intends to eventually reclassify them as Class III devices.
  • Affected manufacturers will have 18 months to obtain Medical Device Licenses (MDL).

Health Canada Pushes for Reduced MDSAP Audit Timeframes

EMERGO SUMMARY OF KEY POINTS:

  • Medical Device Single Audit Program (MDSAP) audit timeframes have been reduced in response to industry feedback received by Health Canada.
  • MDSAP audit time reductions will primarily target smaller medical device companies with limited regulatory compliance resources.
  • All MDL holders active in the Canadian market will have to comply with MDSAP by early 2019.

Health Canada Proposing Major Fee Increases for Medical Device License Applications

EMERGO SUMMARY OF KEY POINTS:

  • Health Canada wants to implement Medical Device License application fee increases for Class II, III and IV medical device registrants.
  • MDL fees have not been significantly adjusted since 2011, according to Health Canada.
  • If implemented, these major MDL fee increases could complicate Canadian market entry for many medical device companies.

MDSAP Update: Health Canada Reports Single-Digit Participation Rate So Far

EMERGO SUMMARY OF KEY POINTS:

  • Health Canada will begin requiring Medical Device License (MDL) holders to participate in the Medical Device Single Audit Program (MDSAP) in early 2019.
  • So far, only 215 of about 3,500 MDL holders required to sign up for MDSAP have done so.
  • Roughly 10% of Health Canada MDL holders are Private Label Medical Manufacturers that do not have to meet ISO 13485 or MDSAP quality system requirements.

In Brief: Health Canada Increases Medical Device License Application Fees for 2017

EMERGO SUMMARY OF KEY POINTS:

  • Health Canada has raised Medical Device License (MDL) and amendment application review fees effective April 1, 2017.
  • Canadian MDL and amendment review fees increase by two percent each year.

Health Canada to Reclassify Medical Device Sterilizers and Disinfectants

EMERGO SUMMARY OF KEY POINTS:

  • Health Canada intends to reclassify medical device sterilizers and disinfectants from drugs to medical devices.
  • Once reclassified, device sterilizers and disinfectants will have to comply with Canadian Medical Devices Regulations.
  • Health Canada's reclassification of device sterilizers and disinfectants is an effort to align more closely with how other market regulators oversee such products.

Canadian medical device market regulator Health Canada plans to reclassify products used to disinfect and sterilize medical devices from pharmaceuticals to devices.

Health Canada Clarifies Performance Targets, Reports Decline in MDL Submissions

Health Canada’s intake of Medical Device License (MDL) applications has shown a slow but steady decrease in the regulator’s number of license approvals from 2011 to mid-2016.

Health Canada Extends Compliance Deadline for Commercially Reprocessed Medical Devices

Health Canada, the Canadian medical device market regulator, plans to extend its deadline for commercially reprocessed devices to obtain Medical Device and Medical Device Establishment Licenses and meet market authorization requirements, according to the agency.

Health Canada Medical Device Licensing Performance on Target in Late 2015

The latest performance report from Canadian medical device market regulator Health Canada shows that the agency met its device licensing and registration targets for the last quarter of 2015 and early 2016.

3 Ways Health Canada Could Simplify Compliance for Medical Device Companies

I have prepared hundreds of medical device submissions for Health Canada over the years. Low risk devices, high risk devices and everything in between.  While Health Canada offers a well-documented path to compliance and is generally very competent, there are some keys areas that continue to confound device companies and that could be improved.

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