Regulatory Open Forum

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  • 1.  Brazil - Device Registrations / Trends

    Posted 25-May-2011 12:16

    The regulatory landscape in Latin America is constantly evolving, with many trends and/or new requirements by local health authorities.  In Brazil, device registrations are getting more complex every day.  Recently, I have experienced the following trend from Anvisa requesting additional information- with focus on the following 6 items. 

    Also, approval timelines vary from 10 to 18 months (with increased number of deficiency letters)
     

    1. Detailed manufacturing flow charts (including brief description of each process step, location where is conducted (address) and quality controls steps and applicable standards (e.g. ASTM, ISO, etc)
    2. Design validation rationale and design FMEA
    3. Standards (e.g. ASTM, ISO) used for product testing (if not explicitly included in the reports) - if based on internal method (non-standardized) need to provide justification
    4. Raw material certifications
    5. Device history records (batch records- only 1 sample)
    6. Photos/images or the final presentation of the product (product box with label)
    If you are experiencing similar or different events - please post and share with our colleagues.  Thanks, Raymond



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    Raymond Seda MBA, RAC
    Regulatory Affairs Manager
    Zimmer Inc

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  • 2.  RE:Brazil - Device Registrations / Trends

    Posted 26-May-2011 08:42
    Hello Raymond

    In fact, all these were already required by law, but Anvisa was not so enforcing. Now the agency has been very focused on technical mattrers related to the product.

    It´s interesting the trend about standards, for some device (equipment and some others) there´s a trand to use a mandatory certification requirement (thru the INMETRO certification process) which is based on standards, as a way to try and reduce the regulatory burden on documentation for registration. In fact, ANVISA is expecting to change a lot of registrations into the cadastre regimen, and require mandatory certification prior to that.

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    Marcelo Antunes RAC
    Regulatory Strategy Consultant
    SQR Consulting
    São Paulo
    Brazil
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    Original Message


  • 3.  RE:Brazil - Device Registrations / Trends

    Posted 26-May-2011 15:25
    I have encountered all of these except they have not asked (so far) for a copy of the DHF.  What they have asked for is non-redacted drawings of all sizes and configurations of all the products being registered.  They also want copies of all articles (even whole books) referenced in our documents such as test reports from a third party and copies of the ISO or ASTM standards used (which are copyrighted and must be purchased to send to them.)

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    Marshall McCarty
    Manager Regulatory Affairs
    Innovasis, Inc.
    Salt Lake City UT
    United States
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    Original Message