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  • 1.  ISO 13485 vs. Therapeutic Goods (Medical Devices) Regulations 2002

    Posted 18-Feb-2016 20:50

    Hi There,

    Does anyone happen to know the best resource to use in order to determine what aspects of Australia's Therapeutic Goods (Medical Devices) Regulations 2002 are not covered by ISO 13485?

    Thank  you!!!

    ------------------------------
    Michael Lynch RAC
    Pleasanton CA
    United States
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  • 2.  RE: ISO 13485 vs. Therapeutic Goods (Medical Devices) Regulations 2002

    Posted 19-Feb-2016 04:44

    Hello Michael,

    Essential Principles Checklist (similar to Essential Requirements Checklist) will help you fill in the gaps between ISO 13485 requirements to the TGA regulatory requirements. Please be advised that ISO 13485 only addresses the quality management system specific requirements not national regulatory requirements.

    In order to demonstrate compliance with the TGA requirements you are required to address the relevant requirements of Essential Principles. Please click the link for the EP Checklist.

    Essential principles checklist (medical devices)

    Therapeutic Goods Administration (TGA) remove preview
    Essential principles checklist (medical devices)
    It is the manufacturer's responsibility to demonstrate compliance with the essential principles for their medical devices.
    View this on Therapeutic Goods Administration (TGA) >

    Hope this helps.

    Kind regards

    ------------------------------
    Romit Singh
    Regulatory Affairs
    Device Technologies Pty Ltd
    Belrose
    Australia

    Original Message


  • 3.  RE: ISO 13485 vs. Therapeutic Goods (Medical Devices) Regulations 2002

    Posted 29-Feb-2016 17:22

    Thank you Both very much!!

    best regards,

    Michael

    ------------------------------
    Michael Lynch RAC
    Pleasanton CA
    United States

    Original Message


  • 4.  RE: ISO 13485 vs. Therapeutic Goods (Medical Devices) Regulations 2002

    Posted 19-Feb-2016 08:45
    Michael,

    You may also refer to TGA MD guidelines (pages 112 through 134) under S6 "what a firm needs to know about conformity assessment."

    It provides details on what ISO clauses can be excluded. 

    For example, under the production QA procedures as part of the conformity assessment procedure, QMS audit will include ISO 13485, excluding clause 7.3, or equivalent standard.  

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



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    Original Message