Aesthetics or medical act? The strengthening of oversight by ERS

The Health Regulatory Authority ("ERS") published, on September 15, 2026, Informative Note No. 03/2026, concerning the "Intervention of the ERS in healthcare related to Aesthetics", together with the Precautionary Measures adopted during the Q2 2026, published on September 9, 2026, which relate exclusively to a topic of increasing prominence in the healthcare sector: the boundary between aesthetics and health.

First and foremost, the question arises:

How to differentiate an aesthetic treatment from a medical act?

The distinction does not depend on how the service is commercially presented, but rather on its characteristics. Only aesthetic procedures that are considered healthcare are subject to ERS regulation. The classification of an aesthetic procedure as healthcare may result, namely, from the product or equipment used – when these are for exclusive use by healthcare professionals – or from the invasive nature of the technique, particularly when it involves injection or implantation of products, or requires anesthesia or sedation.

It is in this context that the provision of aesthetic procedures may raise questions regarding professional qualifications, establishment operating conditions, and compliance with other requirements applicable to healthcare provision.

Risks and consequences of non-compliance

The issue is not limited to the potential usurpation of functions by those without the necessary qualifications – ERS oversight covers broader requirements associated with healthcare provision, including professional qualifications, establishment registration and licensing, operating requirements, use of medicines and medical devices, waste management, and health advertising.

The legal relevance of these cases also extends to the contractual and civil liability level. In 2025, the Lisbon Court of Appeal examined a case related to aesthetic treatments presented as performed by doctors, but which were carried out by a person without such qualification. The Court confirmed the decision of nullity of the contractual relationship underlying the treatments and restitution of the price paid (with the uncanny circumstance that it was proven that the person was satisfied with the treatment results).

The international landscape

The intensification of oversight is not exclusive to Portugal. In the United States, the growth of so-called medical spas has highlighted the widespread absence of regulatory framework – 36 states have no specific regulation – on matters such as establishment ownership, licensing, scope of practice, and supervision by healthcare professionals.

In England, the Government proposed a future risk-based licensing regime for non-surgical cosmetic procedures, distinguishing between lower, medium, and higher risk procedures and providing for differentiated requirements regarding professional qualifications, clinical supervision, and facility conditions. The regime depends, however, on legislation yet to be approved.

What to do: guidance for operators

The evolution of ERS intervention reveals a clear trend – the provision of aesthetic procedures of a clinical nature occupies an increasingly relevant space in the regulator’s supervision of the healthcare sector. This increased attention translates into more frequent inspection actions and significant consequences for operators who do not comply with applicable requirements.

In this context, it is essential that sector operators:

• correctly identify and classify the procedures performed, assessing whether they constitute healthcare and which requirements apply to them;
• confirm the professional qualifications of all professionals who perform procedures and ensure that they act within their respective scope of competence;
• verify the regulatory framework of the establishment, namely regarding registration and licensing with ERS, ensuring that the activity carried out corresponds to the authorized scope;
• ensure compliance with technical and operational requirements, including those relating to medicines, medical devices, equipment, hygiene, safety, and waste management;
• review advertising and commercial communication, ensuring that the presentation of services is not likely to mislead regarding the nature of procedures, professional qualifications, or expected results, in compliance with the Legal Regime for Health Advertising Practices.

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