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  • 1.  Inclusion of Australia in existing MDSAP certificate

    This message was posted by a user wishing to remain anonymous
    Posted 09-Jan-2024 08:29
    This message was posted by a user wishing to remain anonymous

    Hi RA Experts,

    We currently have a valid MDSAP certificate. The scope does not currently include TGA (Australian Regulations).

    Please advise what is the minimum requirement to include TGA successfully in the existing MDSAP certification and the estimated timeline to achieve this.

    Note our company does not have CE therefore we cannot leverage EU documents for Australia.

    Link to any useful resources are welome.

    Thank you.



  • 2.  RE: Inclusion of Australia in existing MDSAP certificate

    Posted 10-Jan-2024 02:48

    Anon,

    You would want to reach out to your Auditing Organisation (AO) to understand this process as it varies slightly from AO to AO.  Depending on the class of device, type of device, maturity of the MDSAP certification for the company this could be a full QMS audit, a "simple" assessment audit, or an audit at the next surveillance.  The timeline would vary because it depends on the AO you are working with currently as their scheduling and timelines can vary with resources.  The information related to Medical Device Single Audit Program (MDSAP) are on the FDA's page https://www.fda.gov/medical-devices/cdrh-international-affairs/medical-device-single-audit-program-mdsap.  The MDSAP program does not matter if you have CE Mark or not because this is an assessment of your quality management system and how compliance with the local regulations are met.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    Oriel STAT A MATRIX - ENTERPRISE
    ------------------------------

    Original Message


  • 3.  RE: Inclusion of Australia in existing MDSAP certificate

    Posted 10-Jan-2024 09:16

    To build on what Richard said, consider using the MDSAP Audit Approach (currently "MDSAP AU P0002.008") to perform a gap analysis of the requirements of the program against your QMS. The Audit Approach document will clearly identify any additional country-specific (Australian) requirements that need to be accounted for. 



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    Michael Thomas, RAC
    Director Regulatory Affairs
    Salt Lake City UT
    United States
    ------------------------------

    Original Message


  • 4.  RE: Inclusion of Australia in existing MDSAP certificate

    Posted 11-Jan-2024 00:48

    To add some additional information for you I have been on the receiving end of an MDSAP audit question. The  US company being audited wanted evidence that the Australian Sponsor name and address details were on the packaging or the product (I am a consultant to the Australian Sponsor). This is listed in the Essential Principles document . This is an example of a very simple question from the auditor which can have unforeseen consequences.

    I am surprised that the TGA requirements were not included as the TGA has been part of the MDSAP program for some time.

    Regards

    Barry

    EBR Consulting Services.



    ------------------------------
    Barry Evers-Buckland
    Director
    Eltham North VIC
    Australia
    ------------------------------

    Original Message


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