Brazil Update: Does RDC 751/2022 Change Labeling Requirements?

By Priscila Sanada and Evangeline Loh

In our recent updates, we discuss RDC 751/2022, classification, the technical dossier, and grouping. We only briefly refer to Chapter 6 on labeling and hence devote this Regulatory Update to that topic. What has changed between RDC 185/2001 ANNEX III.B and Chapter 6 of the RDC 751/2022 (Articles 46-54)?

If one were to compare Section 1 General Requirements with Article 46, it seems many of the provisions are aligned. However, there is now a caveat as part of Article 46(II) that if the instructions for use (IFU) is not included in the packaging, there must be information on how to access the IFU. This is to account for the additional provisions for non-printed format “Formato Não Impresso” in Section II, Articles 50-54.

We will generally refer to this as e- labeling. E- labeling is generally defined as non-printed format such as media, posting to the internet, or in another format deemed permissible (Article 50). E- labeling is now entertained under conditions described by Articles 50-54. However, e- labeling is not permitted when devices are for layperson use (Article 54).

The label requirements appear quite aligned: Section 2 (2.1-2.12) and Article 47 (I-XII). Similarly, the IFU requirements appear quite aligned: Section 3 (3.1-3.16) and Article 48 (I-XVIII). There does appear to be the addition of Article 48(XII) which requires that information is included so that health professionals can inform the patient about potential contraindications and precautions.

In addition, in RDC 751/2022, the technical manager information can be removed from the IFU, and on all labeling, the moniker for “Importador” (Importer) has been replaced by “Detentor do Registro (ou da Notificação)” registration holder).

And, a reminder about the use of symbols as the ABNT (Associação Brasileira de Normas Técnicas or Brazilian Association for Technical Standards) revised the symbol standard in 2022 ABNT NBR ISO 15223-1 Part 1. Hence, the label and IFU requirements between RDC 185/2001 and RDC 751/2022 are quite aligned, though RDC 751/2022 permits e- labeling under certain circumstances.