Drugdu.com expert's response:

For medical devices exported to Brazil, ‌all products that enter the Brazilian market for circulation, sale and clinical use must complete ANVISA-related registration/notification, which is a mandatory pre-requisite for legal entry, and there is no general compliance exemption‌. Below is the complete latest 2026 registration requirements:

1. Core Regulatory Basic Requirements

‌Regulatory Authority‌: All medical devices are uniformly regulated by the Brazilian National Health Surveillance Agency (ANVISA). Overseas manufacturers cannot submit registration applications directly, and must appoint a ‌Brazilian Local Registration Holder (BRH)‌ with a valid Brazilian CNPJ tax number as the legally responsible entity, who is in charge of submitting technical documents, undertaking post-market adverse event reporting, recall execution and other compliance responsibilities.

‌Basic Legal Basis‌: Anchored in Law 6,360/1976, Law 9,782/1999, supported by technical details such as the RDC 751/2022 risk classification rules and RDC 665/2022 GMP specifications.

2. Risk Classification and Corresponding Registration Paths

According to the RDC nº 751/2022 regulation, medical devices are divided into 4 risk levels based on potential risks to the human body, and different levels correspond to different registration channels:

‌Class I Low-risk Devices‌: Such as ordinary medical masks, disposable examination gloves, adopt a simplified notification system with streamlined procedures, and are exempted from system certification requirements.

‌Class II Medium-risk Devices‌: Such as conventional syringes, medical gauze, basic in-vitro diagnostic equipment, follow a simplified registration path. They need to meet system requirements but do not need to submit system materials during application.

‌Class III High-risk Devices‌: Such as electrocardiographs, ultrasonic diagnostic equipment, need to complete the full-process formal registration, and are required to obtain the Brazilian BGMP Quality Management System certification.

‌Class IV Extremely High-risk Devices‌: Such as artificial joints, implantable cardiac pacemakers, are the categories with the strictest ANVISA review. In addition to submitting full technical documents, some products need to supplement local clinical trial data in Brazil.

3. Mandatory Supporting Compliance Requirements

‌UDI Data Submission‌: According to the Normative Instruction 426/2026 that came into effect in February 2026, all products must complete the data upload to the Brazilian UDI database (SIUD) before the specified deadlines: the deadline for Class IV devices is September 29, 2026, the deadline for Class III devices is March 30, 2027, and Class II and Class I devices are also set with corresponding mandatory time limits.

‌Special Pre-certification‌: Active medical devices must first obtain the mandatory INMETRO certification, and products with radio frequency functions need to complete ANATEL compliance at the same time. Both are pre-requisite materials for ANVISA registration and cannot replace ANVISA certification itself.

‌GMP System Requirements‌: Class III and Class IV devices need to complete BGMP certification. Overseas enterprises holding MDSAP certificates can simplify the on-site verification process, while enterprises without MDSAP certificates need to accept the official on-site audit by ANVISA.

4. Technical Documents and General Compliance Requirements

All technical documents must comply with the RDC No.185/2017 and its Annex IV specifications, covering a complete evidence chain including the ISO 14971 risk management report, IEC 62366 usability evaluation, IEC 62304 software full life cycle documents, etc.

All materials must provide a certified Portuguese translation, and the product instructions and labels must be in Portuguese.

The registration certificate issued after ANVISA's review and approval is valid for 5 years.