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INMETRO Certification Time and Cost

Discussion in 'Other Medical Device Regulations World-Wide' started by Maritza Ward, Feb 3, 2016.

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  1. Maritza Ward

    Maritza Ward New Member

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    Hello!

    I am seeking information related to the time and cost associated with INMETRO certification and maintenance. Specifically:

    1) If we provide valid testing (completed within 2 years) that has been certified by an outside accredited test lab, approximately how long does the review/approval time take (including factory inspection)?
    2) How much is the initial inspection and certification?
    3) How much are subsequent annual inspections?
    4) How much to renew the INMETRO certification?
    5) How long does the renewal take to approve?

    I just need a ball park estimate to plug into a regulatory strategy I am putting together.

    Thanks!!
     
  2. QAengineer13

    QAengineer13 Member

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    Hi Maritza,
    I am afraid that I am not answering any of your questions, but I can give you some tips as to ANVISA will be able to accept test reports from any of the accredited labs mentioned below for INMETRO certification,
    · IAF - International Accreditation Forum
    · EA - European Accreditation
    · ILAC - International Laboratory Accreditation Cooperation
    · Interamerican Accreditation Cooperation – IAAC
    · Bureau International des Poids et Mesures - BIPM
    REF : Mutual Recognition Agreements:
    http://www.inmetro.gov.br/english/international/mutual.asp

    My 2C's!
     
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  3. Maritza Ward

    Maritza Ward New Member

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    Thank you for your help!
     
  4. Marcelo Antunes

    Marcelo Antunes Active Member

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    1) If we provide valid testing (completed within 2 years) that has been certified by an outside accredited test lab, approximately how long does the review/approval time take (including factory inspection)?
    2) How much is the initial inspection and certification?
    3) How much are subsequent annual inspections?
    4) How much to renew the INMETRO certification?
    5) How long does the renewal take to approve?

    1) It depends on the schedule factory inspection, after that there will be an evaluation of results that may take some days or 1 month (really depends on the certification body) and then the certificate is given. Anyway, there's more requirements for a test report besides the 2 years (which is required only for the first certification but no revalidation) and outside accredited test lab (which has to be ILAC or EA-traceable). For example, the test reports have to explicitly include all requirements of the applicable standards, between some other requirements.

    2) Pricing depends on the certification body chosen. I've seen prices from BR 10000 to BR 30000 or more.

    3) Pricing depends on the certification body chosen, Usually, costs for maintenance are included, and you would only pay for man-day for inspections, for example (including travel). It depends on the agreement.

    4) Usually the same as a new one.

    5) Usually the same as a new one.
     
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  5. Maritza Ward

    Maritza Ward New Member

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    Thank you! This is great information!
     

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