Labeling and instructions for use requirements under RDC 751/2022

1. Key takeaways

Art. 47 of RDC 751/2022 lists item by item the mandatory information for the label model — 12 items in total — and four of them are the ones the Chinese mainland manufacturers most often miss: the manufacturer’s name and address, the holder’s name and address, the name of the legally qualified technical responsible person, and the notification or registration number prefixed with the ANVISA abbreviation. Paired with the 120-day sell-off period for packaging and instructions for use under Art. 26, label revisions can be scheduled into production planning in advance. Treat the label as a controlled document whose three named parties move together, so any change on one side triggers the revision cycle before an inspection finds it.

2. Legal basis

• Classification, Notification and Registration of Medical Devices, and Labeling and Instructions for Use Requirements — RDC No. 751/2022, decided on September 15, 2022, effective March 1, 2023 (Art. 67), Arts. 11, 25, 26, Art. 33 §5, Art. 33 §6, Arts. 34 through 36, Art. 46 item 1, Art. 47, Art. 51, Art. 54
• In Vitro Diagnostic Medical Devices — RDC No. 830/2023, published on December 11, 2023 (DOU 234), effective June 1, 2024 (Art. 71), Arts. 12, 46 through 48, 55, 67 and 68
• Essential Safety and Performance Requirements — RDC No. 848/2024, published in the DOU on March 8, 2024, Art. 1 §3, Art. 85
• Company Authorization and Sanitary License Regime — Decreto No. 8.077/2013, signed on August 14, 2013, published in the DOU and effective on August 15, 2013 (Art. 26), Art. 5
• Law on Health Product Surveillance — Lei No. 6.360/1976, published on September 23, 1976, Arts. 8 and 12

3. Expert insights

The twelve items of Art. 47 in order are: the manufacturer’s name and address (preceded by the word manufacturer); the holder’s name and address; the information necessary for users to identify the device and the contents of the packaging; where applicable the sterile indication and the sterilization method; the batch number or serial number; the manufacturing date and the expiry date; the single-use indication; storage, care and handling conditions; special operating instructions; all warnings and precautions; the name of the legally qualified technical responsible person; and the notification or registration number prefixed with the ANVISA abbreviation. Art. 46 item 1 sets the general rule: label and instructions for use information must be in Portuguese.

GRZAN’s judgment is that the real difficulty of Art. 47 lies not in presence or absence but in whether the parties are correct. The manufacturer is usually a factory abroad; the holder is the entity holding the registration or notification inside Brazil (the statutory terms detentor de registro and detentor de notificação, known in the industry as the BRH); and the technical responsible person is appointed under Art. 8 of Lei 6.360/1976 and Art. 5 of Decreto 8.077/2013. The most common mistake in a revision is updating only the manufacturer block while missing an adjustment in the holder structure.

The second pitfall is the number field. Class I/II devices follow notification (notificação) and Class III/IV follow registration (registro); the two number formats differ and both must be prefixed with the ANVISA abbreviation. Using the wrong format is judged as a labeling non-conformity.

Third judgment: sell-off has boundaries. Art. 25 permits parallel import and sale of old and new versions until the end of the product’s validity period or useful life; Art. 26 grants packaging, labeling and instructions for use a 120-day sell-off period counted from publication of the change. The provisos in both articles are identical: changes made to resolve safety and performance problems do not qualify, so safety-driven relabeling must switch over immediately rather than riding the sell-off window.

Fourth judgment: the label is downstream evidence of the ESPR. Product sanitary inspections examine exactly the label and instructions for use, and delayed Portuguese revisions typically surface at post-market inspection rather than during review.

Fifth judgment: IVDs cannot copy the device list of twelve. Under Arts. 46 and 47 of RDC 830/2023, the secondary label must, beyond the manufacturer, the holder (including the CNPJ) and the technical responsible person (including the professional council abbreviation and registration number) and the number prefixed with Anvisa, also carry the words in vitro diagnostic use or IVD and list the components with their quantity or volume — calibrators and control materials must be listed separately, and a formula written as an accompanying reagent is judged incomplete; sample or matrix types and materials required by the reaction system must also appear. The primary label follows four additional items under Art. 48, and symbols may follow ABNT NBR ISO 15223. GRZAN’s reading: a device label answers who made it, who is responsible and how to trace it; an IVD label must also answer which sample is measured and by what system the result is produced.

Sixth judgment: electronic instructions for use are not delivered by uploading a PDF. Art. 51 of RDC 751/2022 imposes 4 parallel conditions: informing on the outer label how to obtain the corresponding version of the instructions; stating the consumer service channel through which paper instructions are available free of charge (freight included); guaranteeing availability of the instructions throughout the period the product is on the market; and indicating the resources needed to read the instructions. §1 permits the outer label to be too small for full marking, shifting the duty to accompanying documents; §2 anchors the third condition to the shelf life indicated on the product, counted from the last unit placed on the market. GRZAN’s experience: files often copy the first three conditions and drop the fourth — precisely the one site inspections use to fail the file. Art. 54 adds a prohibition: household devices (including home care use) and devices or materials intended for operation by laypersons must not rely on electronic instructions alone. Do not cross the two article sets: for devices the electronic IFU articles span Arts. 50–54, while for IVDs under RDC 830/2023 they span Arts. 51–55, with Art. 55 holding the prohibition list — self-testing and POCT products cannot be supplied with an electronic version only.

Seventh judgment: the upload deadlines for instructions for use have two starting points, and mixing them means being late. Art. 33 §5 of RDC 751/2022 requires new products, and changes to notified or registered products, to complete the upload within 30 days of DOU publication; Art. 33 §6 requires non-reportable changes that alter the instructions to be uploaded within 180 days of implementation. Art. 34 clarifies that once uploaded the instructions are published on the ANVISA website without documentary review; Art. 35 authorizes ANVISA to verify uploaded instructions or their absence at any time; and Art. 36 penalizes non-conforming content under Lei 6.437/1977, with possible suspension of commercialization, import and use.

4. Practical recommendations

• Maintain a label field table mapping all twelve items of Art. 47 against the Portuguese template.
• Create a linked update mechanism for the three parties — holder, manufacturer, technical responsible person — where any change on one side triggers a revision.
• Distinguish notification and registration number formats, and reserve the ANVISA abbreviation slot in the template.
• Back-plan the 120-day sell-off schedule under Art. 26 for revisions; switch over directly for safety and performance changes.
• Register IFU upload milestones separately under Art. 33 §§5 and 6: within 30 days of DOU publication and within 180 days of implementation.
• Self-check electronic instructions against the four conditions of Art. 51, listing the fourth condition as its own line item; keep providing paper instructions for household and layperson-operated devices and for IVD self-testing and POCT products.

5. Verification checklist

• □ Does the Portuguese label model cover all twelve items of Art. 47?
• □ Are the manufacturer, holder and technical responsible person consistent and current?
• □ Is the number prefixed with the ANVISA abbreviation and formatted for the submission route?
• □ Does the sell-off plan distinguish safety and performance changes?
• □ For IVDs, does the label carry the IVD wording, component list and sample types per Arts. 46, 47 and 48 of RDC 830/2023?
• □ Do household and layperson-operated devices and IVD self-testing and POCT products also receive paper instructions?
• □ Do electronic instructions cover the four conditions of Art. 51, including the most-missed item IV, the resources needed for reading?
• □ Are IFU upload milestones logged against both starting points of Art. 33 §§5 and 6?

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN delivers Portuguese labeling and IFU localization for Brazil — twelve-item label models under RDC 751/2022, IVD labels under RDC 830/2023, electronic IFU condition checks and upload scheduling. For labeling support in Brazil, contact GRZAN at info@grzanglobal.com.