How to Open an Orofacial Harmonization Clinic

Opening your own orofacial harmonization (HOF) clinic is a big step: it involves professional, legal, health, tax and financial decisions that affect one another. The hardest part is not any single item, it is the order. Signing a lease before knowing whether the property allows the activity, or renovating the room before hearing from health surveillance, tends to get expensive.

This guide lays out the path in stages, with the questions to ask at each one and who to ask. It does not replace your accountant, your lawyer, your architect or the guidance of your municipality's health surveillance authority in Brazil. Requirements vary by city and by profession, so treat this page as a map, not as an official roadmap.

What is the order for opening an HOF clinic?

Each municipality has its own process, and some stages happen in parallel. The order above avoids the costliest mistakes, such as renovating before knowing what health surveillance requires.

Stage 1: define the model before spending

Answer in writing:

• Who will treat patients? Only you or other professionals? From which professions?
• Which procedures does the clinic offer, and which does it not?
• What size: one room, two rooms, reception, waiting room?
• What is the positioning? See how to position the HOF clinic.
• What investment is available, and how long can you last until break-even?

If you do not have a patient base yet, consider starting in a rented room or in a partnership and moving later. The pros and cons are in HOF job openings and work models.

Stage 2: check the council rules

Each profession has its own rules about what it may perform, how it may advertise, and how the company relates to the council. There is even a regulatory dispute over who may do what in HOF. So:

• consult the council for your profession (CFO, CFM, CFBM, COFEN, CFF, as applicable);
• ask whether the company needs to be registered with the council and which documents they require;
• check the advertising and trade name rules. See what you may advertise;
• keep the answers in writing.

Stage 3: choose the location with the activity in mind

Before signing the lease, confirm:

• whether the municipality's zoning allows a medical office or health clinic at that address;
• whether the building or its bylaws allow the activity;
• whether the floor plan fits treatment rooms, a sterilization or storage area, a restroom and circulation according to the applicable requirements. Anvisa's (the Brazilian health regulator) standard on physical design of healthcare facilities (RDC 50/2002) is a reference, and local surveillance will tell you what applies in your case;
• whether there is accessibility, ventilation, a handwashing sink and washable surfaces.

Stages 4 and 5: company, regime, CNPJ and CNAE

With your accountant, define the company type and tax regime and register the CNPJ. The activity code (CNAE) must reflect the real activity and what the municipality accepts. See CNAE for an orofacial harmonization clinic.

Points to discuss:

• company type and partners' shares, if any;
• tax regime and its effect on pricing. Use the Simples Nacional vs. individual calculator to compare scenarios, and confirm with your accountant;
• the impact of the tax reform, which changes the rules from 2026 to 2033. See IBS and CBS in the HOF clinic;
• articles of incorporation that reflect the health activity and respect the council.

Stage 6: business permit and health license

The business permit (alvará de funcionamento) is issued by the city hall and depends on zoning, property use and other local requirements. The health license is issued by health surveillance and depends on the activity, the facilities and the technical lead. Timelines, fees and paperwork vary quite a bit. Ask:

• which documents they require for the activity you plan to carry out;
• whether there is a prior inspection and what will be assessed;
• how long it is valid and how to renew it;
• whether you can start seeing patients before it is issued (the answer is usually no, and the local authority decides).

Stage 7: technical lead

Health facilities generally need a technical lead (RT) registered with the council of the corresponding profession. The requirement and who may hold the role depend on the nature of the service, the profession and local rules. In a clinic with professionals from different fields, the arrangement must be confirmed with health surveillance and the councils involved.

Agree in writing on the RT's responsibilities, the time they commit, how they take part in safety routines, and what happens when they are replaced.

Stage 8: waste and biosafety

HOF clinics generate healthcare waste, such as sharps and contaminated materials. Anvisa regulates the management of this waste in RDC 222/2018, which requires the generating service to prepare and monitor a Healthcare Waste Management Plan (PGRSS). See the Anvisa legislation on patient safety and health services and the text of RDC 222/2018 in the Official Gazette.

In practice, this involves:

• collection and disposal by an authorized company, with a contract and receipts;
• proper disposal containers for sharps;
• a room cleaning and disinfection routine;
• a sterilization process or the use of disposable material, depending on the routine;
• staff trained in the routines.

Stage 9: clinical setup and documents

Besides the space, the clinic needs a clinical and documentary foundation:

How much does it cost to open? Hypothetical budget example

Hypothetical example: fictional figures to illustrate the structure of the budget, not representing the real cost in any city.

The item most often left out is working capital. The clinic does not bill enough in the first months, and fixed costs are already running. Calculate the minimum revenue with the clinic break-even calculator and the ticket you need with the average ticket and monthly goal one.

How do I set prices at launch?

Build the price from your cost, not from what the clinic next door charges. Start with the basics in pricing per ml and use the specific pages on botulinum toxin, lip filler, skin boosters and biostimulators. See the effect of installments in the installments and fees calculator.

How do I prepare the commercial launch?

• Define the schedule and follow-up blocks before opening time slots.
• Prepare the script for the first appointment and for the assessment consultation.
• Organize a standardized quote. In Harmy, the quote in PDF comes out with the clinic's name and logo, with the value per ml for each area.
• Plan your communication within the council's rules, with no promise of results.
• If there is a launch campaign, see the page on year-end campaigns for the ethical precautions.

Opening checklist

• Have I defined who treats patients, which procedures and the clinic model?
• Have I consulted the council about company registration and advertising?
• Does the property allow the activity in terms of zoning, building rules and floor plan?
• Has the accountant defined the company type and regime?
• Does the CNAE reflect the real activity and was it accepted by the municipality?
• Are the business permit and health license issued?
• Is a technical lead appointed and registered?
• Are the PGRSS and waste collection contracted?
• Are the medical history form, patient record and consent forms ready?
• Does the working capital cover the first months?
• Do the prices start from the real cost?

Opening an HOF clinic calmly costs less than fixing mistakes later. Ask the right authorities, keep everything in writing, and open the schedule only when regularization is complete.