Brazil ANVISA RDC 830/2023: In Vitro Diagnostic Device Risk Classification and Regulatory Requirements

1. Overview and Scope

Resolution of the Collegiate Board of Directors (RDC) No. 830/2023, effective October 26, 2023, provides the regulatory framework specifically for in vitro diagnostic (IVD) medical devices in Brazil. It covers risk classification, notification and marketing authorization (registration), labeling, instructions for use, technical dossier, alterations, revalidation, and cancellation. Applies to IVDs requiring notification or authorization based on risk class, including instruments and accessories. Exclusions include RUO products, in-house reagents, general lab materials, and certain non-medical uses. SaMD for IVD functions follows complementary rules (RDC No. 657/2022). Source: ANVISA RDC No. 830/2023 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-830-2023-en.pdf)

2. Risk Classification (Classes A to D)

IVDs are classified into four risk classes based on individual and public health risk:

• Class A: Low individual risk, low public health risk
• Class B: Medium individual risk, low public health risk
• Class C: High individual risk, medium public health risk
• Class D: High individual risk, high public health risk

Classification uses 8 rules in Annex I. Highest applicable rule determines the class. Self-testing devices generally Class C (with exceptions). Companion diagnostics typically Class C. Source: ANVISA RDC No. 830/2023 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-830-2023-en.pdf)

Key rules summary:

• Rule 1: Class D for detecting high-risk transmissible agents in blood/tissues/organs or lethal agents.
• Rule 2: Class C for blood grouping (some systems Class D).
• Rule 3: Class C for various infectious agents, companion diagnostics, cancer/genetic testing, etc.
• Rule 4: Self-tests Class C (some Class B if low risk).
• Rule 5: Class A for general reagents, instruments, sample collection.
• Rule 6: Class B for most other IVDs.
• Rule 7: Controls follow main device class.
• Rule 8: Class C for compulsory notification diseases.

ANVISA resolves classification doubts. Source: ANVISA RDC No. 830/2023 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-830-2023-en.pdf)

3. Notification and Marketing Authorization

• Classes A and B: Notification regime with simplified documentation. Indefinite validity.
• Classes C and D: Full marketing authorization requiring technical dossier review, valid for 10 years (renewable).

Petitions include fees, forms, labeling/instructions, technical dossier (C/D), GMP (if applicable), and compliance declarations. Authorization conditional on GMP for relevant cases. Source: ANVISA RDC No. 830/2023 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-830-2023-en.pdf)

4. Performance Evaluation Requirements

Mandatory for Classes C and D. Includes analytical performance (accuracy, precision, sensitivity, specificity, etc.) and clinical performance studies. High-risk IVDs may require evaluation by official laboratories. Studies must demonstrate safety and performance per intended purpose. Source: ANVISA RDC No. 830/2023 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-830-2023-en.pdf)

5. Labeling and Instructions for Use

Must be in Portuguese. Include ANVISA number, manufacturer/holder details, intended purpose, performance characteristics, warnings (especially for self-tests), batch/expiry, storage, and symbols per standards. Instructions mandatory except for very low-risk. Electronic formats allowed under conditions, prohibited for self-tests and lay-user devices. Source: ANVISA RDC No. 830/2023 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-830-2023-en.pdf)

6. Technical Dossier

Maintained by holder, submitted for C/D authorization. Structured per Annex II with increasing detail by class: description, risk management, standards/certificates, performance studies, stability, clinical performance, labeling, manufacturing process. Source: ANVISA RDC No. 830/2023 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-830-2023-en.pdf)

7. Alterations, Revalidation, and Cancellation

Alterations categorized (approval-required, immediate implementation, non-reportable). Revalidation every 10 years for C/D with updated dossier/GMP. Cancellation for non-compliance or safety issues. Source: ANVISA RDC No. 830/2023 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-830-2023-en.pdf)

8. Transitional Provisions

365-day grace period post-October 2023 for reclassification shifts (e.g., notification to authorization requires full submission). Legacy devices maintain validity until changes or revalidation. Source: ANVISA RDC No. 830/2023 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-830-2023-en.pdf)

9. Practical Considerations for RA Managers

Determine classification rigorously using Annex I rules—highest rule applies. Prepare comprehensive performance studies for C/D. Ensure Portuguese labeling and lay-user restrictions for self-tests. Monitor transitional deadlines to avoid cancellation. Source: ANVISA RDC No. 830/2023 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-830-2023-en.pdf)