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ANVISA (RDC 36/2015)

Discussion in 'Other Medical Device Regulations World-Wide' started by QAengineer13, Sep 22, 2015.

  1. QAengineer13

    QAengineer13 Member

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    ANVISA published today, 27 August 2015, the DRC 36/2015 resolution repealing the RDC 206/06 and RDC 61/11 resolutions, establishing in this way, new rules for Risk Rating, Registration, Registration, Labelling and Instructions for Use Products for In Vitro Diagnostic (IVD).

    The RDC 36/2015 implements several new features, such as the examples below, but you need a detailed reading on the resolution to identify all changes.

    Here are some of the new requirements:

    • Instruments for use in in vitro diagnostics become registered or registered by GEVIT;
    • Products for in vitro diagnostic risk class II shall be subject to Registry (formerly the IVD product risk class II were subject to registration);
    • All products, regardless of risk category should have a Technical Dossier, however, the dossiers IVD Products risk class I should not be sent to ANVISA and shall be filed in the company for disease control purposes;
    • The Technical Dossier has several items / documents, including risk management and usability;
    • Models labeling and use instructions should be referred for evaluation of ANVISA, regardless of the product category of risk;
    • Products subject to Register (Hazard Classes I and II) need not be revalidated.
    Resolution RDC 36, 2015 shall enter into force on 26 October 2015 (60 days after publication).
     

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  2. QAengineer13

    QAengineer13 Member

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    Recently, ANVISA published the Normative Instruction n°4/2015 regarding INMETRO certification which replaces the Normative Instruction n°11/2014, and the standard IEC61010-2-101:2002 has been removed from the certification scope. It means that INMETRO certification will not be a mandatory item for ANVISA registration requests.
     

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