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health canada

  1. A

    Certification procedure for OEM/PLM collaboration in the medical device industry in the US - Who bears the regulatory responsability?

    What is the certification procedure for OEM/PLM collaboration in the medical device industry in the US? Who must bear the regulatory responsability?
  2. Marcelo Antunes

    Informational Health Canada advises Allergan of its intent to suspend its licences for Biocell breast implants as a precautionary measure

    Health Canada advises Allergan of its intent to suspend its licences for Biocell breast implants as a precautionary measure Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  3. Marcelo Antunes

    Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada

    Notice: Device Advice: Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  4. Marcelo Antunes

    Informational Health Canada begins release of clinical data

    Based on this guidance – Public Release of Clinical Information: guidance document, see this website: Search for clinical information on drugs and medical devices - Canada.ca Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  5. world217

    SOP for Vigilance reporting covering multiple requirements

    Hi, I am working in QA for a medical device start-up company. I am currently working to update our procedure for Vigilance reporting (MDD compliant) to also make it compliant with both FDA and Health Canada requirements. What I find difficult is not to write the procedure, but how to...
  6. Marcelo Antunes

    Informational Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format

    Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  7. M

    Informational Links to recognized / harmonised / consensus Standards for each market

    Forgive me if this is already listed elsewhere, but I thought it might be a helpful resource to give links to the regional recognized / harmonised / consensus standards. Here's the links I have so far: Europe: Harmonised Standards (ec.europa.eu) USA: Recognized Consensus Standards...
  8. S

    Health Canada's Action Plan on Medical Devices - 2019 milestones

    What does everyone think of Health Canada's upcoming action plan? Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality - Canada.ca
  9. S

    IDE to support premarket submissions

    Hello everyone, I am new to the world of investigational testing. How much weight can we assign to feasibility data in a premarket submission? Can we use feasibility data to support class II applications? For those familiar with Health Canada's regulations, there is a parallel investigational...
  10. Marcelo Antunes

    Medical Device News Health Canada – Consultation: Pre-market Requirements for Medical Device Cybersecurity

    Cybersecurity is and will be a hot topic in the medical devices field for a long time, as more and more devices are connected. Health Canada (together with the US FDA) are two of the regulatory bodies more concerned with this topic. Here is a link to a recent consultation on a guidance document...
  11. F

    Can an individual apply for an MDEL in Canada, as an establishment?

    Hi All, I have come up against a unique situation for a client in Canada (unique for me as this is the first time I am experiencing this). Can an individual apply for an MDEL in Canada, as an establishment? I have done quite a lot of health canada registrations in the past but have not come...
  12. M

    Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management

    Health Canada issued this notice of intent back in April regarding "Strengthening the post-market surveillance and risk management of Medical Devices". As written in the notice, most of the proposed changes are written in the format "Provide the Minister with the authority to...". Does this...
  13. Sidney Vianna

    Interesting Read Article from Grant Ramaley in QD - MDSAP: When Is a Certificate Not a Certificate?

    The whole article is available @ MDSAP: When Is a Certificate Not a Certificate? | Quality Digest The Dental Trade Alliance learned from its members in February 2018 that the Canadian Health Ministry (“Health Canada”) had contacted the Standards Council of Canada (SCC) and the British...
  14. Marcelo Antunes

    Medical Device News Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018

    Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 - Canada.ca
  15. Marcelo Antunes

    Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan

    Health Canada - Notice: Medical Device Single Audit Program (MDSAP) Transition Plan - Frequently Asked Questions (FAQ) Notice: Medical Device Single Audit Program (MDSAP) Transition Plan - Frequently Asked Questions (FAQ) - Canada.ca
  16. Marcelo Antunes

    Medical Device News Health Canada update - Applications for Medical Device Investigational Testing Authorizations

    Health Canada Notice: Applications for Medical Device Investigational Testing Authorizations – Changes to the Timing of Research Ethics Board (REB) Approval Notice: Applications for Medical Device Investigational Testing Authorizations – Changes to the Timing of Research Ethics Board (REB)...
  17. Marcelo Antunes

    Medical Device News Health Canada - Proposed Changes - List of Recognized Standards for Medical Devices

    Health Canada - Proposed Changes to the Therapeutic Products Directorate’s List of Recognized Standards for Medical Devices Proposed Changes to the Therapeutic Products Directorate’s List of Recognized Standards for Medical Devices - Canada.ca
  18. Marcelo Antunes

    Medical Device News Health Canada Update - 05-09-18 - Pilot Device Advice

    Health Canada - Device Advice: Health Canada launching a new pilot project to formalise a framework aimed at offering regulatory advice to medical device manufacturers Notice: Device Advice: Health Canada launching a new pilot project to formalise a framework aimed at offering regulatory...
  19. Marcelo Antunes

    Medical Device News Health Canada update 28-08-18 - Licensing Requirements for 3D-Printed Devices

    Health Canada - Upcoming Guidance Development on the Licensing Requirements for 3D-Printed Devices Notice: Upcoming Guidance Development on the Licensing Requirements for 3D-Printed Devices - Canada.ca
  20. D

    How will the new MDSAP requirements affect the MDEL?

    How will the new MDSAP requirements affect the MDEL? Will Health Canada now monitor the manufacturers which are listed on the MDEL to see if they have passed the MDSAP before issuing a new/updated licence?
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