Medical devices play a fundamental role in the practice of modern medicine, offering a variety of essential tools for diagnosis, treatment, and monitoring of health conditions. These devices range from simple equipment such as thermometers and glucose monitors to advanced technologies like magnetic resonance imaging and medical implants. By enabling early disease detection, enabling less invasive procedures, and ensuring more efficient monitoring, medical devices contribute significantly to the advancement of health and well-being of the population.
Among the various types of medical devices – as defined by RDC nº 751/2022 – in vitro diagnostic medical devices stand out due to their multiple applications in the healthcare field. Because it is a complex and specialized regulatory subject, in vitro diagnostic products (IVDs) are governed by a specific resolution: RDC nº 36/2015.
By definition, an IVD is a reagent, software, sample collector, or other article used for the in vitro analysis of samples derived from the human body, exclusively or primarily, with the purpose of providing information for diagnostic, monitoring, compatibility, screening, or determination of physiological status.
The classification is carried out following the guidelines of RDC nº 36/2015, according to the most applicable rule for the product. Following this analysis and determination of the class, the process of petitioning for notification or registration with ANVISA begins.
- Class I: Low-risk devices that are simple and well-established. Generally, they are non-invasive and include reagents and products auxiliary to IVD procedures, culture media, and sample collectors for IVD.
- Class II: Moderate-risk devices that can be more complex than Class I devices. Some IVD test parameters are included in this category, such as hormone detection, and professional instruments dedicated to IVD.
- Class III: High-risk devices that are complex and generally require a more rigorous evaluation before being approved. Examples include devices used in genetic tests, molecular diagnostic tests, and sexually transmitted agent detection tests.
- Class IV: Special devices, usually of high complexity, used for advanced testing and which may require a significant level of clinical evidence to demonstrate safety and efficacy. This may include devices used in advanced diagnostic tests for severe or complex communicable diseases, such as HIV tests.
The classification establishes the type of process that will be submitted: IVD products of Class I and II are subject to notification, while those of Class III and IV are subject to registration. In the case of notifications, the technical analysis of documents by ANVISA constitutes a more simplified process. Specifically for Class I, it is not
necessary to prepare a technical dossier, only to submit certain information. For products targeted for registration, it is necessary to submit, in addition to the technical dossier, a Good Manufacturing Practice (GMP) Certificate process to ANVISA as a prerequisite.
According to Regulatory Instruction nº 3, dated August 26, 2015, in vitro diagnostic medical devices that are included in a grouping list for IVD families can be registered or grouped as a family, provided that a series of requirements are met. These include the stipulation that they must be products of the same composition, technology, legal manufacturer, and intended for interdependent and exclusive use.
Furthermore, besides the mentioned documents, an IVD product may also require a Conformity Certificate (ANATEL, INMETRO) or a pre-analysis report deemed satisfactory by a unit of the National Network of Public Health Laboratories. This applicability should be evaluated on a case-by-case basis, according to the specificities of the product.
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