Class IV medical device: fillers and ANVISA
Quick facts
- Definition
- A medical device placed in the highest-risk class by ANVISA (Brazil's health regulatory agency).
- Rule
- RDC No. 751/2022, which defines classes I to IV, the classification rules, and the notification and registration regimes.
- Regime
- Classes III and IV require registration; classes I and II, notification.
- In facial harmonization
- Injectable fillers and biostimulators are high- or highest-risk medical devices.
- Not a device
- Botulinum toxin and hyaluronidase are registered as drugs.
A class IV medical device is the health product that ANVISA places in the highest-risk class. The classification is in RDC No. 751/2022, which organizes medical devices into four classes, from I (low risk) to IV (highest risk), and establishes that those in classes III and IV can only be marketed with registration. In facial harmonization, injectable fillers and biostimulators are regulated as high- or highest-risk medical devices.
What are the risk classes?
| Class | Risk | ANVISA regime |
|---|---|---|
| I | Low | Notification |
| II | Medium | Notification |
| III | High | Registration |
| IV | Highest | Registration |
The class is not freely chosen by the manufacturer: it results from classification rules that consider, among other points, whether the product is invasive, how long it stays in the body, whether it is absorbed, and whether it acts on sensitive organs. In case of doubt, ANVISA determines the classification. RDC No. 751/2022 replaced the former RDC No. 185/2001 and took effect in March 2023.
What is a device and what is a drug in facial harmonization?
| Product | Category | Where to check |
|---|---|---|
| Hyaluronic acid filler | High- or highest-risk medical device | Health products |
| Calcium hydroxylapatite, poly-L-lactic acid, polycaprolactone | High- or highest-risk medical device | Health products |
| PDO threads, cannulas, and needles | Medical device (class depends on the product) | Health products |
| Botulinum toxin | Biological drug | Drugs |
| Hyaluronidase | Drug | Drugs |
Registration approves a specific product, from a specific manufacturer, with the indications and areas described in the instructions for use. The exact class of each filler is in its registration, in ANVISA's public database. The step-by-step lookup is in how to check an injectable's registration at ANVISA, and the case of the enzyme in hyaluronidase at ANVISA.
Why does it matter in the office?
- Product origin: a class III or IV device without valid registration is unlawful. Buy from a supplier that can prove provenance.
- Instructions for use: they define the approved areas and purposes. Use outside what is provided is off-label and calls for careful consent and documentation.
- Traceability: the lot, expiration date, and product label should go into the patient record. See injectable traceability.
- Adverse event: a technical complaint or event involving a medical device is reported through ANVISA channels, as explained in adverse event reporting.
Also called: class IV health product, highest-risk correlate (old term), highest-risk device.
Frequently asked questions
Is hyaluronic acid filler a drug or a medical device?
In Brazil, hyaluronic acid fillers are regulated as high- or highest-risk medical devices, subject to registration with ANVISA. The class of each product appears in the public health products database.
Is hyaluronidase a class IV medical device?
No. Hyaluronidase is registered as a drug, just like botulinum toxin. The registration is checked in ANVISA's drugs section, not the health products section.