Brazilian Health Regulatory Agency (ANVISA) has introduced new legislation enabling manufacturers of high-risk medical devices to use registrations from certain foreign regulatory authorities for market access in Brazil. Starting June 3, ANVISA will now rely on decisions made by authorities from other jurisdictions, though it remains independent and responsible for the final decisions. This approach is part of regulatory convergence, which aligns with international best practices and standards. Regulatory convergence allows ANVISA to leverage these authorizations, giving significant weight to assessments made by other regulatory authorities, ultimately speeding up the approval process and reducing administrative burdens for manufacturers.
ANVISA based on RDC 741/2022, establishing the process for leveraging authorizations from an Equivalent Foreign Regulatory Authority (AREE). This applies only to Class III and IV medical devices and IVDs, which typically undergo the registro regulatory process. IN 290/2024 defines AREEs as four former Global Harmonization Task Force (GHTF) founding members: the Australia Therapeutic Goods Administration (TGA), Health Canada, the U.S. Food and Drug Administration (FDA), and the Japan Ministry of Health, Labor and Welfare (MHLW).
Leveraging Foreign Authorizations for High-Risk Medical Devices
The AREE authorizations that can be leveraged include the TGA’s Australian Register of Therapeutic Goods (ARTG), Health Canada’s Medical Device License, the U.S. FDA’s 510(k) Clearance, Premarket Approval (PMA), or 513(f)(2) “De Novo”, and MHLW’s pre-market approval (Shonin). If multiple AREE authorizations are available, the Brazil Registration Holder may refer to all of them but must choose one AREE as a reference for the entire process. Despite leveraging these authorizations, the technical dossier and related documents, as required by RDC 751/2022 for high-risk medical devices or RDC 36/2015 updated by RDC 830/2023 for IVDs, must still be submitted. Compliance with other registration requirements, such as INCQS, B-GMP, INMETRO, or ANATEL certificates, remains mandatory.
To qualify for AREE review, the required documents include a signed declaration by the Technical Manager and Legal Responsible Person, evidence of authorization in the AREE country (consularized or apostilled, plus sworn translation if not in Portuguese, English, or Spanish), and the IFU for the high-risk medical devices in the AREE (plus sworn translation if not in Portuguese, English, or Spanish). Devices registered must be identical to those authorized in the AREEs. ANVISA reserves the right to require registration through normal procedures if inconsistencies are found. Applications under this route will follow the same initial registration steps as a normal submission, potentially reducing ANVISA review time by about 30%.
Advancing Regulatory Harmonization and Accelerating Market Access for High-Risk Medical Devices
ANVISA may reject a Reliance process application if supplementary documentation is incomplete or unsatisfactory, device indications for use differ from those approved by the AREE, significant design changes prevent using the AREE’s analysis, or correlation between the product regulated by the AREE and the submitted product is not possible. The Reliance route marks a significant step for regulatory leveraging in Brazil. Over time, ANVISA and the industry will better understand the efficiency gains from using authorizations from AREEs. ANVISA joins other regulators leveraging authorizations from other markets, promoting global regulatory harmonization. As discussed at the recent International Medical Device Regulators Forum (IMDRF) 25th meeting, this is another triumph for global regulatory harmonization among regulators.
This new pathway not only accelerates market access for innovative high-risk medical devices but also ensures that Brazilian patients benefit from advanced healthcare technologies. The success of this initiative will depend on its implementation and continuous improvement based on feedback and real-world application. ANVISA’s commitment to regulatory convergence and leveraging international best practices is a positive step towards a more efficient and responsive regulatory environment.
Resource: Emergo by Ul, June 05, 2024
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