The registration of medical devices in Brazil is a critical step for manufacturers looking to enter this expansive market. ANVISA (Agência Nacional de Vigilância Sanitária) has established a streamlined process known as the Reliance Pathway, which allows the agency to utilize assessments made by recognized foreign regulatory authorities. This blog will delve into the details of this pathway, highlighting its benefits, requirements, and the specific regulations that govern it.
The Landscape of Medical Device Market in Brazil
Currently, around 70% of medical devices available in Brazil are manufactured outside the country, with the USA and China being the primary exporters of medical devices to Brazil. ANVISA recognizes the need to optimize the registration process to facilitate faster access to technologies, particularly by utilizing assessments from equivalent foreign regulatory authorities (AREE). The estimated time for an optimized analysis via this Pathway is about 30% less than that required for traditional routes.
What is the ANVISA Reliance Pathway for Medical Devices in Brazil?
The Reliance Pathway enables ANVISA to consider and give significant weight to assessments made by trusted foreign regulatory authorities when making its own regulatory decisions. While ANVISA can rely on these assessments, it remains responsible and accountable for the decisions it makes regarding medical device approvals.
ANVISA Regulations Governing Device Registration through the Reliance Pathway
On August 10, 2022, ANVISA published RDC 741/2022, which establishes the general criteria for the reliance pathway in product assessments and approvals. This resolution mandates the issuance of product-specific normative instructions. Subsequently, ANVISA released two normative instructions, one for Medical Devices and another for Pharmaceuticals, Vaccines, and Biological Products.
RDC 741/2022: This resolution sets the general criteria for medical device registration in Brazil.
Medical Devices Normative Instruction IN 290/2024: Released on April 4, 2024, this instruction will come into effect on June 3, 2024, and provides specific guidelines for the registration of medical devices through the Reliance Pathway.
Pharmaceuticals and Biologics Normative Instruction IN 289/2024: Released on 20th March 2024 and is in effect from 1st April 2024. This is relevant for companies also involved in pharmaceuticals and biologics.
Eligible Medical Devices for ANVISA's Reliance Pathway in Brazil
The Reliance Pathway primarily applies to:
Medical Devices Classified as Class III and IV: These are considered high-risk devices. The pathway is designed to streamline the registration process for these products, leveraging analyses conducted by recognized foreign authorities.
Lower-Risk Classes: Devices classified as Class I and II already follow an abbreviated route known as the Notification Regime and are not covered by this regulatory framework.
ANVISA Recognized Equivalent Foreign Regulatory Authorities (AREE)
ANVISA acknowledges specific medical device registration pathways from the regulatory authorities of various countries as equivalent. These foreign regulatory bodies or international entities have practices aligned with ANVISA’s, ensuring that products authorized for distribution are thoroughly evaluated and meet recognized standards of quality, safety, and efficacy. ANVISA considers these authorities in its regulatory trust practices.
Country | Equivalent Foreign Regulatory Authority (AREE) | Medical Device Registration Pathway |
Australia | Therapeutic Goods Administration (TGA) | Australian Register of Therapeutic Goods (ARTG) Listing |
Canada | Health Canada (HC | Medical Device License (MDL) |
United States of America | Food and Drug Administration (FDA) |
|
Japan | Ministry of Health, Labor and Welfare (MHLW) | Premarket Approval (Shonin) |
Criteria for Medical Devices Utilizing the Reliance Pathway in Brazil
To use the Reliance Pathway, the following criteria must be met:
Prior Authorization: The medical device must be previously authorized by at least one recognized AREE. If a company is approved by multiple recognized authorities, it can submit more than one dossier from these partner authorities. However, it must specify which reference AREE it intends to use to demonstrate that the medical device is essentially identical to the one it seeks to approve with ANVISA, as required in the Declaration in the Annex to IN No. 290/2024.
Essentially Identical Device: The device intended for registration in Brazil must be essentially identical to the one approved by the AREE, including similar indications for use and manufacturer details. small market-driven changes can be made without altering their essential characteristics, as long as their indications for use and safety/performance remain unchanged.
No Abbreviated Procedures: Devices that have been authorized through abbreviated procedures similar to ANVISA’s optimized analysis will not qualify.
ANVISA Documentation Requirements for Medical Device Registration through Reliance Pathway in Brazil IN 290/2024
The documents required for medical device registration must include all those outlined in RDC No. 751 or RDC No. 830. In addition to these documents, applicants must provide additional materials to qualify for the reliance pathways. The following documentation is necessary for registration under the Reliance Pathway:
Declaration: A declaration as specified in the Annex to IN 290/2024, electronically signed by the legal and technical representatives.
Proof of Registration: Documentation verifying the device's registration or authorization by an AREE, which must pertain to the essentially identical medical device intended for Brazil. These documents must be in Portuguese or English or Spanish and must be apostilled. If these documents are in other languages, they must be must be accompanied by sworn translation into any of these languages.
Instructions for Use: Instructions that are currently in effect within the AREE’s jurisdiction, accompanied by a sworn translation if needed.
Situations for Refusal of the Optimized Analysis
ANIVISA may decide to reject the application for the Reliance Pathway and instead use the standard analysis procedure for the submitted documents. The company will be notified of this decision via an Electronic Letter (Datavisa). Here are the circumstances under which the optimized analysis procedure (Reliance) may be declined:
Incomplete or unsatisfactory supplementary documentation.
Different indications for use compared to those approved by the AREE.
When the medical device being analyzed has experienced significant design changes that render the AREE analysis unusable
Lack of correlation between the product approved by the AREE and the one submitted to ANVISA.
Step-by-Step Process for the Reliance Pathway for Medical Device Registration in Brazil
The application process consists of two petitions: a primary petition and a secondary petition.
Primary Petition: This primary petition is for the registration of Class III or Class IV medical devices.
Secondary Petition: The secondary Pathway petition for the reliance pathway must be submitted as a secondary request, accompanied by supplementary documentation.
Filing Process: All registration requests (including materials, equipment, IVDs, and orthopedic materials) should be filed through the “Solicita” system. The reliance pathway petition must include a specific addendum subject. Secondary petitions for optimized analysis are subject-specific and will be managed according to the internal procedures of GGTPS, which are currently being implemented. Therefore, it is crucial to select the appropriate subject for your petition.
Subject code | Petition Subject Description |
80300 | MATERIAL - Amendment - Request for optimized analysis according to Normative Instruction IN No. 290/2024 |
80301 | ORTHOPEDIC MATERIAL - Amendment - Request for optimized analysis according to Normative Instruction IN no 290/2024 |
80302 | EQUIPMENT - Amendment - Request for optimized analysis according to Normative Instruction IN no 290/2024 |
80304 | IVD - Amendment - Request for optimized analysis according to Normative Instruction IN No. 290/2024 |
Maintain Compliance: Ensure that all submitted documents are consularized, as this is mandatory for the registration process.
Analysis Process: The primary registration petition will be “granted,” while the secondary petition for optimized analysis will be “approved.” If the optimized analysis petition is “not approved,” the primary petition will proceed through the ordinary analysis route, adhering to the timelines established by RDC No. 743/2022
Key Considerations for Companies aiming to register medical devices through Reliance Pathway
Essential Similarity: Medical devices subjected to the optimized analysis must maintain essential similarity with those approved by the reference authority.
Multiple AREE Approvals: If a device is approved by multiple recognized authorities, companies can present more than one dossier. However, they must indicate which AREE they wish to rely upon for their submission.
Labeling Compliance: The labeling and instructions for use in Portuguese must align with the approved versions from the AREE.
The Reliance Pathway represents a significant advancement in the registration process for medical devices in Brazil. By leveraging assessments from equivalent foreign regulatory authorities, ANVISA is enhancing the efficiency and speed of device approvals. For manufacturers, understanding and effectively navigating this pathway can lead to faster market access and reduced costs, making it an essential strategy for those looking to enter the Brazilian healthcare market. Staying informed about the latest regulations and maintaining compliance will be key to successfully utilizing this streamlined approach.
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