Regulatory Open Forum

 View Only

  • 1.  Health Canada medical device clinical trial inspection

    Posted 17-Jun-2019 10:12
    Hi everyone, 

    Does anyone have experience with device clinical investigations in Canada?  I understand there is a Health Canada inspection every 3 years or so for compliance with the device regulations.  However, how is the conduct of the clinical trial inspected for conformity with ISO 14155?   

    Thanks.

    ------------------------------
    Karen Zhou
    ------------------------------


  • 2.  RE: Health Canada medical device clinical trial inspection

    Posted 17-Jun-2019 11:30
    Edited by Brittany Gibson 17-Jun-2019 11:31
    Hi Karen,

    I have done several device investigations in Canada before.  Health Canada only inspects Class I manufacturers, and importers and distributors of all classes of medical devices.  They have an inspection program for drug clinical trials, but in my experience (Class II devices), clinical sites have never been inspected. 

    Health Canada has stated that ISO 14155 is generally similar to the HC MDR, but where differences exist, the MDR takes precedence.  As part of the submission, protocols, consent forms, investigators and site information is required.  For Class III and IV trials, signed investigator agreements and the IRB approval (when available) are required.  They expect that manufacturers follow their guidance (Applications for Medical Device Investigational Testing Authorizations), which references ISO 14155 a few times.

    I hope this helps!

    Best,
    Brittany

    ------------------------------
    Brittany Gibson BSc
    Director, Quality and Regulatory Affairs
    Winnipeg MB
    Canada
    ------------------------------

    Original Message


  • 3.  RE: Health Canada medical device clinical trial inspection

    Posted 18-Jun-2019 10:02

    Hi Karen,

    The design, conduct, recording and reporting of clinical investigations carried out in human subjects (i.e. ISO 14155) is assessed at the time of applying for Investigational Testing Authorization (ITA) by the Medical Devices Bureau and not during an inspection.

    Health Canada inspections, conducted by the Regional Operations and Enforcement Branch, are primarily conducted for "importers" and "distributors" of medical devices authorized for general marketing (licensed product) who require a Medical Device Establishment Licence (MDEL). MDEL Inspections typically occur on a cycle of 3-5 years and examine the effectiveness of procedures that are required to be in place (Mandatory Problem Reporting, Recall, Distribution Records, Complaint Handling, and Handling, Storage, Delivery, Installation, Corrective Action and Servicing).

    Health Canada has the authority to inspect manufacturers, importers and distributors of medical devices subject of investigational testing. Such an inspection would focus on examining compliance with sections 79 to 81 and 86 to 88 or the Medical Devices Regulations and for SOPs mentioned above in relation to importation and distribution. See Health Canada guidance document GUI-0064. Inspections of investigational sites are possible but rare and would focus on the proper conduct of the trial in accordance with the study protocol, investigator agreement, etc.

    A "manufacturer" is required to demonstrate compliance with ISO 13485:2016 via a MDSAP audit by recognized 3rd party audit organizations but this is required to obtain general market authorization (product licensing) and not for ITAs.



    ------------------------------
    Don Boyer RAC, FRAPS
    President, BOYER@RegulatorySolns
    Ottawa ON
    Canada
    ------------------------------

    Original Message


Related Content