Scope: |
NOTE: This ESSENTIAL is based on the ANVISA RDC 36/2015, valid until 31-MAY-2024.
Starting 01-JUN-2024, the new RDC 830/2023 will come into force.
This CRF describes the regulatory requirements of In-Vitro Diagnostics in Brazil, based on the
- ANVISA Resolutions
- Additional information from Brazilian authorities webpages
IVD products are classified into four risk classes, according to the risk associated with their use (RDC 36/2015 - Art.4):
Class I: products of low risk to the individual and low risk to public health;
Class II: products of medium risk to the individual and low risk to public health;
Class III: products of high risk to the individual and or medium risk to public health; It is
Class IV: products of high risk to the individual and high risk to public health.
Not in scope of this ESSENTIAL: Medical Devices (please see: ESS BRA Medical Devices)
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Legislation in force: |
Abbreviation: RDC 36/2015
Risk classification, notification, registration control regimes and labeling requirements and instructions for use of in vitro diagnostic products, including their instruments.
Art. 2 This Resolution applies to in vitro diagnostic products manufactured in the national territory and those manufactured in other countries that may be imported into Brazil.
Section II of the Resolution lists the Classification Rules.
ANVISA RDC No. 665 of 30-MAR-2022
Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products.
Article 1. This regulation provides for the Good Manufacturing Practices (GMP) for Medical Products and In Vitro Diagnostic Products, establishing the requirements that describe the GMP for methods and controls used in the design, purchasing, manufacturing, packaging, labeling, storage, distribution, installation, and technical assistance applicable to the manufacture of medical products and in vitrodiagnostic products.
Article 2. This regulation applies to manufacturers, distributors, storers, and importers of medical products and In Vitro Diagnostic products that are commercialized in Brazil.
Definitions:
II - quality audit: an established, systematic, and independent examination of a manufacturer's entire quality system, performed at regular intervals and with sufficient frequency to ensure that the quality system’s activities and its results comply with the procedures specified in its quality system.
(amended by ANVISA NI No. 30:2019)
Art. 1 - This Normative Instruction regulates item I of art. 20 of the Resolution of the Collegiate Board of Directors-RDC No. 36, of August 26, 2015, which provides for the risk classification, the notification and registration control regimes and the labeling requirements and instructions for use of in vitro diagnostic products, including its instruments and other provisions.
Art 2 - Products from the same legal manufacturer, with similar characteristics of technology, methodology and indication, may be registered or registered as a family of products, provided that they are included in the same group as determined
in this Normative Instruction.
Resolution - RE No. 392 of 20/02/2018
Recognizes the Medical Device Single Audit Program (MDSAP) to support health inspection and inspection actions.
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