3 min read
Introduction
Brazil, with its growing healthcare market, presents significant opportunities for medical device manufacturers. Recently, Brazil took an initiative that aims to expedite the evaluation of products that have already been approved by reputable foreign regulatory authorities, ultimately ensuring faster access to innovative medical technologies for the Brazilian population. This blog will delve into the details of the Reliance Regulatory Framework implemented by ANVISA, exploring its components, benefits, and implications for medical device manufacturers seeking to enter the Brazilian market.
The New Procedure: Normative Instruction (IN) 290/2024
On April 8, 2024, ANVISA published Normative Instruction (IN) 290/2024, which outlines an optimized procedure for analysing and deciding on petitions related to medical device registration. This new approach aligns with recommendations from the World Health Organization (WHO) and allows ANVISA to recognize approvals from foreign regulatory bodies, thereby accelerating the evaluation process for devices that have already been deemed safe and effective with other health authorities. It should be noted that 290/2024 is applicable exclusively to Class III and IV medical devices and in vitro diagnostics (IVDs), which are generally required to undergo the Registro regulatory process.
The Reliance Regulatory Framework in Brazil is designed to streamline the registration and approval processes for medical devices. This framework allows ANVISA to leverage assessments conducted by foreign regulatory authorities that are recognized as equivalent, thereby expediting the evaluation of products already approved in other jurisdictions. By leveraging assessments from equivalent foreign regulatory authorities, ANVISA not only enhances its operational efficiency but also contributes to the global harmonization of regulatory practices, ultimately benefiting public health in Brazil.
Principles for Using the Reliance Pathway
The guidelines established in the regulatory standards are grounded in principles aimed at maintaining the integrity and efficacy of the regulatory process. This involves the thorough submission of all necessary documentation, adherence to relevant Brazilian laws, and proof of equivalence between products already approved by foreign regulatory bodies and those being reviewed by ANVISA.
Key Features of the Reliance Regulatory Framework
- Recognition of Equivalent Regulatory Authorities: The framework identifies certain foreign regulatory bodies, known as Equivalent Foreign Regulatory Authorities (AREEs), that have regulatory practices aligned with those of ANVISA. Recognized authorities include:
- S. Food and Drug Administration (FDA)
- Health Canada
- Therapeutic Goods Administration (TGA) of Australia
- MHLW - Pre-market approval (Shonin)
- Streamlined Processes: By utilizing assessments from these recognized authorities, ANVISA can expedite the approval of medical devices and other health products. This is particularly beneficial for high-risk medical devices (Classes III and IV) as outlined in Normative Instruction 290/2024, which allows for an abbreviated analysis process for products already recognized by an AREE. It is noted that the medical device to be registered with ANVISA must be essentially identical to the device approved by AREE regulatory bodies.
The request for registration of a medical device via an abbreviated analysis procedure must include the documents required by RDC No. 751 (September 15, 2022) and RDC No. 830 (December 6, 2023), along with the following complementary documentation
- Documentation Requirements: To apply for marketing authorization using the optimized procedure, manufacturers must provide:
- Signed declaration (Annex I template) by Technically and Legally Responsible Person
- Proof of marketing authorization from the AREE.
- A statement of eligibility that includes product details and the reference to the AREE.
- Instructions for use that comply with the AREE's regulations (plus sworn translation if not in Portuguese, English, or Spanish).
- Implementation Timeline: The Reliance Regulatory Framework was officially approved during a public meeting on March 19, 2024, and is set to take effect on June 3, 2024. This timeline allows stakeholders to prepare for the new procedures and ensures a smooth transition.
- Public Consultation and Stakeholder Engagement: The development of this framework involved extensive public consultation, allowing industry stakeholders to provide input and refine the proposed guidelines. ANVISA engaged in dialogues with various foreign regulators to share best practices and enhance the framework's effectiveness.
Benefits and Next Steps
Implementing this procedure is anticipated to yield several advantages:
- Expedited Access: Companies can now move through the registration process more quickly, shortening the time-to-market for medical devices.
- International Harmonization: By acknowledging approvals from respected foreign authorities, Brazil aligns with global best practices.
- Virtual Seminar: ANVISA conducted a virtual seminar on 290/2024 on April 29th, 2024, and provided detailed information about the new guidelines and answer questions from interested companies.
As ANVISA continues to refine and implement these new procedures, it is essential for medical device manufacturers to stay informed and prepared. To know more about the Reliance Regulatory Framework and Normative Instruction (IN) 290/2024, we recommend keeping up with the latest updates. For further information and assistance, contact our regulatory experts who can guide you through the process and help you achieve successful market entry.
