Canada Blog Posts

Canadian Regulators Launching Tailored Approach to Digital Health Technologies

EMERGO SUMMARY OF KEY POINTS:

  • Health Canada is establishing a new division for premarket review of digital health technologies.
  • The new Digital Health Review Division will handle licensing of wireless medical devices, mobile medical apps and related digital health products.
  • Health Canada plans to align its new division with similar digital health oversight initiatives by the US FDA and other regulators.
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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).
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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.
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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.
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In Brief: US FDA, Brazil ANVISA Expand Lists of Qualified Audit Organizations for MDSAP

EMERGO SUMMARY OF KEY POINTS:

  • US and Brazilian medical device market regulators have updated their lists of organizations authorized to conduct QMS audits under the Medical Device Single Audit Program (MDSAP).
  • There are now four companies recognized as MDSAP auditing organizations and 13 organizations authorized by the US FDA to carry out audits.
  • Brazil’s ANVISA now recognizes nine MDSAP audit organizations.
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Health Canada Crafting Rules for Mandatory Incident Reporting by some Hospitals

  • New mandatory medical device incident reporting rules proposed by Health Canada
  • Scope includes all acute-care hospitals in Canada
  • 30-day timeframe for incident reporting proposed
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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.
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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.
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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.

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MDSAP Authorities Push for Medical Device Industry Participation

Officials overseeing the Medical Device Single Audit Program (MDSAP) developed to allow single quality system audits across multiple regulatory jurisdictions have issued an official request for participation to medical device manufacturers ahead of the program’s full implementation deadline.

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