Facial Harmonization in Biomedicine: CFBM Rules

Anyone searching "can a biomedical professional do facial harmonization" finds opposing answers, often from people with a direct stake in the topic. The safest way to understand the issue is to look at the rules of the Federal Council of Biomedicine (CFBM) one by one, with number, date and subject, and then see what the courts decided about them.
This page builds that map. Status checked on October 20, 2026, against texts published by the CFBM and news of court decisions. It does not state what biomedical professionals may or may not do: it reports what the rules and decisions say and points to where to confirm. For any professional decision, consult the Regional Council of Biomedicine (CRBM) in your region. This page is not legal advice.
What is the legal basis of the biomedical profession?
In Brazil, the profession is regulated by Law No. 6,684/1979, as amended by Law No. 7,017/1982, and by Decree No. 88,439/1983. These rules created the CFBM and the regional councils and gave the federal council the power to issue acts interpreting and enforcing the law.
The dispute turns on this point: the CFBM maintains that its resolutions on aesthetics detail what the law allows; medical bodies maintain that they expand duties beyond the law, in conflict with Law No. 12,842/2013, the Medical Act Law.
Which CFBM resolutions cover aesthetics?
| Rule | Date | Subject, according to its summary | Known status |
|---|---|---|---|
| Resolution No. 197 | February 21, 2011 | Duties of biomedical professionals in aesthetic health and acting as technical manager of aesthetics businesses | Cited by the CFBM in CONAMI Ordinance No. 1/2023 |
| Resolution No. 200 | July 1, 2011 | Criteria for qualification in aesthetic biomedicine | Cited by the CFBM in CONAMI Ordinance No. 1/2023 |
| Resolution No. 214 | April 10, 2012 | Earlier rule on work in aesthetics | Repealed by Resolution No. 307/2019 |
| Resolution No. 241 | May 29, 2014 | Acts of biomedical professionals qualified in aesthetic biomedicine and prescribing for aesthetic purposes | Annulled at first instance; annulment upheld by the TRF1 in 2026 |
| Resolution No. 307 | May 17, 2019 | Aesthetic biomedicine specialty; use only of substances registered with ANVISA (Brazil's health regulator) and regulated by the CFBM | Published in the DOU (Federal Official Gazette) on May 21, 2019 |
| CONAMI Ordinance No. 1 | October 19, 2023 | Inspection protocol for the safety of aesthetic procedures performed by biomedical professionals | CFBM inspection act |
The CFBM also issued guidelines on specific procedures, such as CFBM Guideline No. 003/2015, on an injectable aesthetic procedure for small vessels. Before relying on any guideline, check on the CFBM website whether it is in force and whether a court decision has affected it.
What did Resolution 241/2014 say?
It was the rule most cited in the harmonization debate. It regulated the prescription and use of substances, including injectables, by biomedical professionals qualified in aesthetic biomedicine, and listed among aesthetic products type A botulinum toxin and fillers. It also detailed what the prescription must contain. This is the rule whose annulment was upheld by the TRF1.
Qualification is not the same as the dental specialty
Resolution No. 200/2011 speaks of qualification in aesthetic biomedicine, registered with the CRBM. The text provided for a provisional qualification, with a deadline of December 31, 2012, and a permanent qualification, which requires a postgraduate certificate or specialist title in aesthetics. "Orofacial harmonization," on the other hand, is the name of the specialty recognized by the Federal Council of Dentistry; its history is in HOF as a dental specialty.
What did the courts decide about CFBM rules?
| Item | What is known |
|---|---|
| Case | Lawsuit No. 0067987-48.2015.4.01.3400, filed by the Federal Council of Medicine |
| First instance | Declared CFBM Resolution No. 241/2014 null |
| TRF1 | The 7th Panel unanimously denied the CFBM's appeal, per a news report of March 18, 2026 |
| Reported grounds | Law No. 6,684/1979 would not authorize independent performance of invasive procedures, even aesthetic ones, and a council resolution cannot expand powers set by law |
| Motions | The same Panel rejected the CFBM's motions for clarification, per a CFM news item dated May 29, 2026 |
| Next steps | Appeals to the higher courts are possible; check progress with the TRF1 |
The news items cited come from the CFM, which is a party to the case. The CFBM, in earlier statements, said it would seek to reverse the ruling in the higher courts. Over the years, other lawsuits have also challenged CFBM resolutions and guidelines on aesthetics, with preliminary rulings at different times. The overview of lawsuits among councils, including the dentistry one, is in the HOF legal dispute.
What should you follow if you are a biomedical professional in aesthetics?
- Rules in force at the CFBM. Published resolutions, guidelines and ordinances, and any repeals.
- Court progress. Case No. 0067987-48.2015.4.01.3400 and other lawsuits cited by your council.
- CRBM guidance. If in doubt about a specific procedure, ask in writing and keep the answer.
- Health surveillance. The service's license, technical manager and facilities also follow health regulations. See technical manager at the HOF clinic.
- Approved products. Resolution No. 307/2019 limits use to substances registered with ANVISA. See how to look up an injectable's registration with ANVISA.
- Advertising. Follow the ethics and advertising rules of your profession and CONAR (Brazil's advertising self-regulation body); do not present yourself with the title of another profession.
What about documentation?
When rules are being challenged, documentation is the best protection for both patient and professional, whatever the profession:
- A complete medical history, with medications, allergies and previous procedures.
- Informed consent specific to each procedure, with risks and alternatives.
- A patient record with product, lot number, quantity and treated area.
- Standardized photos before and at follow-up.
The guide is in patient record and documentation in HOF, and the steps to reduce the risk of a lawsuit are in lawsuit over harmonization: how to prevent it.
How to answer the patient who saw the news?
Avoid answering by attacking other professions. The conversation with the patient should be about safety, indication and expectations, not about the dispute among councils.
What about the other professions?
| Profession | Council | Where to read more |
|---|---|---|
| Dentistry | CFO | HOF regulation at the CFO |
| Medicine | CFM | Facial harmonization and the CFM |
| Pharmacy | CFF | Aesthetic pharmacy (CFF) |
| Nursing | COFEN | Aesthetics in nursing (COFEN) |
And in Harmy?
Checklist for biomedical professionals following the rules
- Resolutions 197/2011, 200/2011, 241/2014 and 307/2019 checked on the CFBM website.
- Status of Resolution 241/2014 followed through case No. 0067987-48.2015.4.01.3400.
- CRBM guidance on specific procedures requested in writing.
- Qualification in aesthetic biomedicine registered with the CRBM.
- Products registered with ANVISA, with the lot number noted in the patient record.
- Complication flow and medical referral in writing.
- Advertising reviewed according to the rules of the profession.
Frequently asked questions
Can a biomedical professional perform facial harmonization?
The CFBM (Brazil's Federal Council of Biomedicine) regulated aesthetic biomedicine through its own resolutions, but CFBM Resolution No. 241/2014, which covered the acts of the aesthetic biomedical professional, had its annulment upheld by the 7th Panel of the TRF1 (Federal Regional Court) in March 2026. The situation depends on how the case progresses and on official guidance; check with your regional CRBM before any decision.
Which CFBM resolution covers aesthetic biomedicine?
The main ones are 197/2011 (work in aesthetic health and technical responsibility), 200/2011 (qualification criteria), 241/2014 (acts and prescribing by the aesthetic biomedical professional, annulled in court) and 307/2019 (specialty and use of substances registered with ANVISA).
Can a biomedical professional perform orofacial harmonization?
Orofacial harmonization is the name of the specialty recognized by the Federal Council of Dentistry. In biomedicine, the field is called aesthetic biomedicine and follows CFBM rules, which are also under legal dispute. Confirm with your regional council what is currently in force.
What did the TRF1 decide about CFBM Resolution 241/2014?
In March 2026, the TRF1's 7th Panel unanimously upheld the ruling that annulled CFBM Resolution No. 241/2014, in case No. 0067987-48.2015.4.01.3400. It later rejected the CFBM's motions for clarification. Check with the TRF1 whether further appeals are still possible.
Harmy images are illustrative simulations generated by AI from the patient's photo to support the conversation between practitioner and patient. They are not a promise of results. Indication, technique, product and volume are solely the decision of the licensed practitioner. This content is for information only and does not replace a clinical assessment.