Brazil’s Normative Instruction No. 290/2024: What You Need To Know

This blog was originally posted on 13th May, 2024. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY FERNANDA PARO, REGULATORY COMPLIANCE SPECIALIST, COMPLIANCE & RISKS

Introduction

The Brazilian Agency for Sanitary Surveillance (ANVISA) published Normative Instruction No. 290/2024 on 8 April 2024 to streamline the evaluation process for medical devices and in vitro diagnostic devices (IVD) that have already been approved by foreign authorities.

It establishes an optimized procedure for the analysis and decision-making regarding medical device registration petitions, utilizing analyses performed by an Equivalent Foreign Regulatory Authority (EFRA).

In this blog, we examine the finer details of Normative Instruction No. 290/2024.

Overview of Normative Instruction No. 290/2024

Normative Instruction No. 290/2024 represents a significant advancement in the adoption of regulatory trust mechanisms on an international scale. The Instruction is set to enter into force on 3rd June 2024. It stipulates that the foreign authority must have approved the medical device through a standard process, not an abbreviated or reduced one. Devices approved via any reduced process will follow normal procedures and will not be eligible for the optimized procedure.

Currently, the number of recognized foreign authorities is limited. However, the Instruction specifies the following four, along with their registration/authorization evidence:

Australia: Therapeutic Goods Administration (TGA) – Australian Register of Therapeutic Goods (ARTG);
Canada: Health Canada (HC) – Medical Device Licence;
United States of America (USA): US Food and Drug Administration (FDA) – 510(k) Clearance, Premarket Approval (PMA), or 513(f)(2) “De Novo”;
Japan: Ministry of Health, Labour and Welfare (MHLW) – Pre-market approval (Shonin).

In addition to authorization by one of the listed authorities, the documentation issued by the EFRA must reference the identical medical device intended for national registration and include the manufacturer’s intended use instructions.

The Instruction details the documents required for the optimized procedure application, following Resolutions RDC No. 751/2022 and RDC No. 830/23.

Devices approved through the optimized procedure will be under the same requirements and classifications of sanitary infractions and applicable penalties. Additionally, ANVISA will maintain its decision-making autonomy, regardless of the determinations made by the Equivalent Foreign Regulatory Authority (EFRA).

References:

Stay Ahead Of Regulatory Changes Like Normative Instruction No. 290/2024

Accelerate your ability to achieve, maintain & expand market access for all products in global markets with C2P – Your key to unlocking market access, trusted by more than 300 of the world’s leading brands.
C2P is an enterprise SaaS platform providing everything you need in one place to achieve your business objectives by proving compliance in over 195 countries.

C2P is purpose-built to be tailored to your specific needs with comprehensive capabilities that enable enterprise-wide management of regulations, standards, requirements and evidence.
Add-on packages help accelerate market access through use-case-specific solutions, global regulatory content, a global team of subject matter experts and professional services.

Accelerate time-to-market for products
Reduce non-compliance risks that impact your ability to meet business goals and cause reputational damage
Enable business continuity by digitizing your compliance process and building corporate memory
Improve efficiency and enable your team to focus on business critical initiatives rather than manual tasks
Save time with access to Compliance & Risks’ extensive Knowledge Partner network