RDC 830/2023 comes into force from june 1, 2024
RDC 830/2023, provides for the risk classification notification and registration regimes, and labeling requirements and instructions for in vitro diagnosis, including their instruments, comes into force from the 1st of june 2024.
With the publication of the RDC 830/2023, several changes to the regulation of in vitro diagnostic medical devices were made , including:
- The RDC 830/2023 removed the products below froom the list of non-applicable products, that is, these products must be considered in the new RDC:
IV – laboratory reagentes intended for diagnosis in any type of non-human sample.
XI – software for in vitro diagnostics not embedded in the equipment, which is dealt with in specific regulations.
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RDC 830/2023 does not apply to products intended exclusively for use in technical assistance or maintenance procedures.
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Change of some definitions and inclusion of definitions that are in accordance with the current context, facilitating the understanding of the legislation.
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Inclusion of specific classification rules, such as:
f) to be used as diagnostic tests for therapeutic selection or to provide essential information for the safe and effective use of a medicine or biological product (used as companion diagnostic medical devices);
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Alteration of some classification rules.
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Added to RDC 830/2023 a section to deal with the types of Change notification and Registration of Medical Device for in vitro Diagnostics – Change of immediate implementation, change of approval required and non-reportable alteration.
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Permission to deplete the stock of packaging, labels and instructions for use for a period of 120 days from the publication of the alteration.
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Labels and instructions for use:
New text:
“the inclusion of information from national companies on labels in addition to the legal manufacturer and/or holder of the registration or notification is prohibited;”
“When the dimensions of the product packaging allow, information about instructions for use may appear on its label.”
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Inclusion of a list of devices for which instructions for use in non-printed format are not permitted.
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The dossier format has been changed. It is similar to the dossier presented in RDC 751/2022.
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Establishes a period of 365 days, counting from June 1, 2024, for notification holders to file petitions for sanitary reclassification of products that had their notification regime modified for registration according to the classification rules.
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Control devices without assigned quantitative or qualitative values that are now classified as medical devices for in vitro diagnosis and products for the extraction of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA), auxiliary to in vitro diagnostic procedures, must be duly regularized within 365 days from June 1, 2024.
Is your company ready for the changes? Update yourself, access the Portuguese version of RDC 830/2023.
With the entry into force of RDC 830/2023, the following legislation will be revoked:
I – the Resolution of the Collegiate Board of Directors – RDC nº 36, of August 26, 2015;
II – the Collegiate Board Resolution – RDC nº 211, of January 22, 2018;
III – the Collegiate Board Resolution – RDC nº 270, of February 28, 2019;
IV – the Collegiate Board Resolution – RDC nº 340, of March 6, 2020;
V – the Collegiate Board Resolution – RDC nº 403, of July 21, 2020;
VI – the Collegiate Board Resolution – RDC nº 431, of October 13, 2020;
VII – the Collegiate Board Resolution – RDC nº 27, of May 2, 2008;
VIII – Normative Instruction – IN nº 30, of March 19, 2019;
IX – Normative Instruction – IN nº 4, of June 15, 2012;
X – art. 11 of the Normative Instruction – IN nº 3, of August 26, 2015.
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Published on: 01/16/2024
