ANVISA RDCs that apply to a facial harmonization clinic

"Does ANVISA require this?" is a question almost every orofacial harmonization (HOF) professional in Brazil has asked, usually after hearing from an inspector, a colleague or a supplier that "there is an RDC about that." The problem is that RDC is a generic name for hundreds of rules, and confusing one with another can lead you to spend money on something that does not apply, or to miss something that does.

This guide presents, in an organized way, the RDCs that most often come up for HOF clinics, what each one covers, how to tell whether it applies to your service and how to check whether it is still in force. It is not legal or sanitary advice: the health surveillance office of your municipality or state defines what applies to your case, and rules change. The information was checked against public sources at the time of writing, and validity must be rechecked on the ANVISA portal.

What is an RDC and who inspects?

RDC stands for Collegiate Board Resolution, the kind of rule the ANVISA board issues to regulate services and products under health surveillance. It coexists with laws, ordinances and state and municipal rules.

In practice, the chain looks like this:

For licensing documents, see health license for a HOF clinic.

Which RDCs come up most often?

The five rules above are general references. Some have exceptions to their scope depending on the type of service, and local surveillance may adopt other rules of its own. See each one below.

RDC 63/2011: good operating practices

This is a broad rule that applies to public and private health services and defines requirements for organization and operation, focused on qualification, humanization and reducing risks to users and the environment. In a clinic's routine, the topics show up as:

• Technical manager and the service's responsibilities;
• Patient record and documentation of care;
• Standard operating procedures (SOPs) for the relevant routines;
• Cleaning and disinfection of rooms and surfaces;
• Staff management and training;
• Water quality and control of vectors and pests;
• Maintenance of equipment and facilities.

In practical terms, this is the rule behind many of the questions an inspector asks during a visit. It is worth reading the full text, or asking the technical manager to summarize it for the team.

RDC 50/2002: physical design

It guides the drafting and assessment of physical designs for health care establishments, whether new, renovated or expanded. It is the rule behind questions such as "does the room need a sink?", "what should the floor finish be?" and "how do I separate the materials area?".

A few points of attention:

• Local surveillance may require a design review before construction.
• The rule is extensive and covers a variety of establishments; what applies to an outpatient procedure office is only part of it, and surveillance tells you which part.
• There are reports that ANVISA is revising the rule. Check the portal for an updated version.

For the impact on construction and rent, see opening a HOF clinic.

RDC 222/2018: health service waste

It regulates good practices for managing health service waste. It divides waste into five groups: A (possible presence of biological agents), B (chemical substances), C (radioactive waste), D (common waste, with no biological, chemical or radiological risk) and E (sharps). For HOF clinics, groups A, B, D and E are the most frequent. The rule underpins the waste management plan (PGRSS). This subject is explained in PGRSS in the HOF clinic.

In parallel, environmental rules such as CONAMA Resolution 358/2005 address the treatment and final disposal of health waste, and municipal legislation defines collection.

RDC 36/2013: patient safety

It establishes actions for patient safety in health services, such as the safety plan, the patient safety unit, reporting of adverse events and monitoring of indicators. According to the text of the rule, solo practices are among the services excluded from its scope, among other exceptions. Because the classification of a "solo practice" is made by local legislation, do not assume you are in or out: ask surveillance.

Even when the rule does not formally apply, its principles are useful in the clinic: written protocols, checking the patient and the procedure, and recording and analyzing complications. See safety and complications in HOF and patient records and documentation.

RDC 15/2012: processing of health products

It covers good practices for processing health products in sterilization departments and at processing companies. Some services and individual practices are among the exceptions in the text, and surveillance clarifies the classification. If the clinic works only with disposable material, the SOP should say so explicitly. If instruments are reprocessed, the cleaning, disinfection or sterilization routine and its controls must be defined. See the concept of asepsis.

What about rules on products, medicines and advertising?

ANVISA also regulates the products used in the clinic: medicines, health products and cosmetics. The question "is this product registered?" is answered by consulting the official database. See:

• how to check an injectable's registration with ANVISA;
• hyaluronidase at ANVISA and hyaluronidase in the office.

Advertising of health procedures is regulated by the professional councils, the Consumer Protection Code and CONAR (Brazil's advertising self-regulation body), and ANVISA has its own rules for advertising medicines and products. See advertising in HOF.

How do I know which ones apply to my service?

1. Identify the type of establishment, as local surveillance classifies it (office, clinic, outpatient service).
2. Ask the health surveillance office of your municipality (or state, where applicable) for the list of rules and documents required for your activity. Ask in writing, or note the protocol number of the answer.
3. Check each rule's exceptions in the official text.
4. Ask the technical manager to turn the list into a checklist and SOPs.
5. Review whenever the service, the location or a rule changes.

How do I check whether the rule is in force?

RDCs are amended and repealed, and old PDFs circulate for years on blogs and in groups. The safest route:

• Go to the ANVISA portal (gov.br/anvisa) and search for the rule by number and year.
• Check whether there is a consolidated version or amendment notes.
• Compare with the Federal Official Gazette when you need the original text.
• Check whether a public consultation or revision is under way.
• Confirm with surveillance that it adopts the same version.
• Record the date you checked and the version consulted.

How do I turn the rule into routine?

Knowing the rule is not enough. What surveillance observes is the routine. One way to organize it:

The emergency checklist helps build the complications part, and the medical history form standardizes the base of the documentation.

What happens if the clinic does not comply?

The consequences depend on local legislation and the type of violation, and may include a notice to correct, a fine, partial or full shutdown, suspension of activity and, in serious cases, liability in other spheres. In addition, non-compliance weighs on any dispute with a patient: in a dispute, the fact that the clinic operated outside the rules is used against the professional. See lawsuits over facial harmonization: how to reduce legal risk.

Common mistakes

• Citing an RDC from memory, without checking the number, date and validity.
• Applying a hospital rule to a small office without checking the exceptions.
• Copying SOPs from another clinic without adapting them.
• Trusting PDFs from messaging groups.
• Renovating without consulting surveillance.
• Believing that "ANVISA does not inspect small clinics."
• Forgetting to review the rules when they change.

RDC compliance checklist

• Did I ask local surveillance which rules apply to my service and keep the answer?
• Did I read the updated text of each rule (63/2011, 50/2002, 222/2018, 36/2013 and, if applicable, 15/2012)?
• Did I check each one's exceptions?
• Do I have SOPs that describe what actually happens in the clinic?
• Does the PGRSS exist, has the team been trained and is the collection licensed?
• Do the products in use have registration and are they stored according to the manufacturer?
• Do I have patient records, consent and a record of the batch in use?
• Did I define when and who will review the rules?

Knowing the RDCs is less about memorizing numbers and more about knowing where to look, whom to ask and how to turn the rule into a written routine that the team actually follows.