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  • 1.  Document Archiving Requirements for FDA, MDR EU and Health Canada

    Posted 20-Apr-2021 13:40
    Dear all,

    Here is a summary according to the information I currently have:

    Health Canada
    Clinical trials (including subjects' medical records): 25-year retention

    FDA
    Medical device registration: Minimum: 2 years otherwise life of device.

    MDR EU
    Technical documentation, declaration of conformity and supplementary documents: Minimum: date of implantation of last device plus 15 years.

    But what I noticed in all document I read is that no one specifies what form the documentation should take (electronic or paper).
    Do we have any other regulatory requirements or legal considerations please? What are they?

    Thank you in advance for your help.

    Rgds,


    ------------------------------
    Nadine Adia
    Quebec QC
    Canada
    ------------------------------


  • 2.  RE: Document Archiving Requirements for FDA, MDR EU and Health Canada

    Posted 21-Apr-2021 10:34

    Nadine,

    My interpretation is that the documentation needs to be preserved for the required number of years
    in the form (paper or electronic) that was current and compulsory at the time of the dossier submission.

    Most likely the format of the documentation is captured in another guidance document.

    In Canada, this is the latest (to my knowledge) guidance on the CTA applications:
    https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/clinical-trial-sponsors-applications.html#a232

    Section 2.3.2 Clinical Trial Application (CTA) Format
    "The CTA should be submitted on electronic media, accompanied by a hard copy cover letter, and be organized in accordance with the current electronic specifications: Guidance Document: Preparation of Drug Regulatory Activities in the "Non-eCTD Electronic-Only" Format."


    In the case of electronic files, I would recommend (and most likely you have IT people looking into this already) having 
    the files on two different media, i.e. if you have the official copy on CDs or DVDs, to have the backup copy on a removable HDD, or on the internal network, instead of a second CD or DVD.
    Considering how fast IT technology advances, we now need an external CD reader to access data on a CD, because most usual laptops are now "notebooks" that barely have enough USB ports.

    I hope this helps.
     



    ------------------------------
    Sorin Alb RAC
    Project Manager, Regulatory Affairs
    Scarborough ON
    Canada
    ------------------------------

    Original Message


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