Medical device regulatory news from the Americas includes enhanced safety and performance standards in Brazil; new device classifications from the US FDA; and a policy for classifying combination products in Canada.
On September 18, 2024, ANVISA published (link in Portuguese) an amendment to the result of Call for Proposals Notice 10/2023. A total of 107 submissions were reviewed, with ten innovative projects selected to join a pilot program. This initiative aims to support the development of new medical devices based on cutting-edge technologies, providing closer regulatory oversight and facilitating market entry in Brazil. The pilot project reflects ANVISA’s commitment to advancing health innovation and improving accessibility to novel medical solutions.
On September 13, 2024, ANVISA announced (link in Portuguese) the creation of the Technical Chamber for Clinical Research on Medicines and Medical Devices (Catepec). Established under Joint Ordinance 2, this new body aims to provide technical and scientific support to ANVISA's Coordinations of Clinical Research (Copec and CPPRO). Catepec will enhance the regulatory evaluation of clinical trials, assist in monitoring scientific developments, and streamline processes related to the registration and post-registration of medicines and medical devices. ANVISA has issued a call for professionals to join the chamber, with applications open for 30 days.
As of September 4, 2024, ANVISA's new Collegiate Board Resolution (RDC) 848/2024 (link in Portuguese) is in force, replacing RDC 546/2021. The updated regulation enhances safety and performance standards for medical devices, now also including in vitro diagnostic (IVD) devices. The changes align with global technological and scientific advancements, ensuring that medical products are designed for their intended use, function safely, and present acceptable risks relative to their benefits. RDC 848/2024 strengthens Brazil's commitment to international regulatory convergence and collaboration with the IMDRF and Mercosur.
Learn more about ANVISA Brazil Medical Device Registration.
On September 16, 2024, the FDA announced the classification of the clozapine test system as a Class II device with special controls, as detailed in the Federal Register (Document No. 2024-20895). This classification is aimed at ensuring the safety and effectiveness of the device, which is used to measure clozapine levels in human specimens, crucial for monitoring therapy in patients with treatment-resistant schizophrenia. The new regulations include specific design verification and validation requirements to mitigate risks such as incorrect test results and misinterpretation. This action enhances access to innovative medical devices while aligning with FDA's commitment to regulatory efficiency and patient safety.
The U.S. Food and Drug Administration (FDA) has officially classified the Pediatric Continuous Renal Replacement Therapy (PCRRT) system into Class II with special controls. This device, used for managing acute kidney injury and fluid overload in pediatric patients, will now follow specific performance, safety, and labeling requirements. The FDA's decision aims to enhance patient access to innovative treatment systems while ensuring safety and effectiveness. This ruling was enacted on September 16, 2024, and stems from Medtronic's De Novo classification request for the CARPEDIEM System.
On September 16, 2024, the FDA issued a final order classifying a new device for detecting nucleic acids from viruses linked to head and neck cancers into Class II with special controls. This in vitro diagnostic test, used in conjunction with other clinical data, provides valuable insight into the likelihood of virus-associated head and neck cancers. The classification into Class II ensures a balance between safety, effectiveness, and enhanced patient access to innovative medical devices.
Learn more about FDA US Medical Device Registration.
The Therapeutic Products Classification Committee has outlined the policy for classifying combination products involving drugs and medical devices. Depending on the principal mechanism of action—whether pharmacological, immunological, metabolic, or mechanical—the product will fall under either the Medical Devices Regulations or the Food and Drug Regulations. This policy provides a framework for determining classifications for complex products, such as prefilled syringes, drug-coated devices, and wound dressings, ensuring proper regulatory compliance. The list is periodically updated to address new and unique products.
Learn more about CDMR Canada Medical Device Registration & Approval.
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IVD manufacturers cite the new classification system, detailed definitions for intended purposes, and the need for verification of clinical evidence as key challenges under the IVDR.
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On October 23, the European Parliament adopted a resolution revising specific elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). This resolution intends to address ongoing challenges in implementing the regulations by 2025 and to improve patient access to important medical products.
Multilingual documentation presents ongoing compliance and logistical hurdles for MedTech manufacturers. Transla.Ai is an industry-specific translation tool that can accelerate and streamline the translation process.