Authorities urge providers of aesthetic treatments to ensure compliance with legislation

The Finnish Supervisory Agency (LVV), the Finnish Medicines Agency (Fimea), the Finnish Safety and Chemicals Agency (Tukes) and the Radiation and Nuclear Safety Authority (STUK) urge providers of aesthetic treatments to ensure that their services comply with applicable legislation. Based on supervisory findings, many operators in the beauty sector are not sufficiently familiar with the legislation governing their activities or do not comply with it.

Providers of aesthetic services must comply with a wide range of legislation

Service providers are responsible for identifying the legislation that applies to their activities and ensuring that they comply with all applicable requirements. The legislation that applies depends on the services provided. Aesthetic services are governed by, among others, the Act on the Supervision of Social and Health Care, the Act on Health Care Professionals, the Medicines Act, the Act on Medical Devices, the Radiation Act and the Act on the Safety of Consumer Services.

The products and procedures used in aesthetic treatments often involve significant risks. Particular attention should be paid to the products and devices used in injectable treatments and treatments using high-energy devices. It is also essential to ensure that the devices used comply with all applicable requirements.

The authorities remind service providers that neither cosmetic products nor devices used in aesthetic treatments are subject to prior inspection or approval by any authority. These products are not authorized before being placed on the market; instead, regulatory oversight takes place after they have entered the market. The authorities therefore advise providers to exercise particular caution when sourcing products and devices from outside the European Union, as their safety cannot always be verified.

Botulinum toxin treatments are always health care services

Botulinum toxin is a medicinal substance that may only be administered on the basis of a prescription issued by a licensed physician. In addition to physicians, botulinum toxin may be injected by licensed health care professionals who have appropriate training and sufficient competence to administer botulinum toxin injections. Appropriate training refers to education that includes adequate training in injection techniques, such as the education provided for registered nurses, public health nurses and midwives. Other health care professionals are not permitted to administer botulinum toxin treatments.

In addition, the health care professionals referred to above must have completed specific training in the administration of botulinum toxin. The supervising physician must verify the competence of registered nurses, public health nurses and midwives who administer botulinum toxin treatments and provide them with written authorization to perform these injections.

The physician is always responsible for medication

A physician must assess the need for botulinum toxin treatment regardless of its intended use. A physician may prescribe botulinum toxin only to a person whose need for the medicine has been established through the physician's own examination or by another reliable method.

The physician remains responsible for botulinum toxin treatment even when the administration of the injection has been delegated to a registered nurse, public health nurse or midwife. If the person administering the injection is not a physician, the injection must be given under the physician's direction and supervision.

The physician must be immediately available at the health care service unit while botulinum toxin is being administered so that they can effectively supervise the procedure and intervene if necessary. Immediate availability means that the physician must be present at the health care service unit or in its immediate vicinity throughout the administration of the injection. This requirement cannot be fulfilled through a remote consultation. For the purposes of the botulinum toxin treatments described above, a licensed dentist is regarded as equivalent to a physician.

More information: Botulinum treatments – Finnish Supervisory Agency (FI) 

Medicinal products must be authorized for use in Finland

Medicinal products used in aesthetic treatments (such as botulinum toxin products and topical anesthetics) must have a valid marketing authorization in Finland and must be obtained from a Finnish pharmacy. Only pharmacies are authorized to dispense medicines, and medicinal products must not be obtained from other suppliers. For special medical reasons, a physician may prescribe a medicinal product that does not have a marketing authorization in Finland. In such cases, the pharmacy must apply to the Finnish Medicines Agency (Fimea) for a patient-specific special permit, and the medicinal product must be dispensed through a pharmacy.

The Medicines Act specifies who is authorized to import medicinal products. Neither the operator of a beauty clinic nor a physician or dentist is entitled to import medicinal products into Finland solely by virtue of their profession. Medicines imported for personal use may not be used in professional practice.

Products intended for use in treatments, such as injectable treatments, are available through various sales channels and may be classified as medicinal products under Finnish legislation. These may include, for example, lipolysis products and hyaluronidase injections. Before such products are purchased or used, their legal status under Finnish legislation must be verified.

Online marketplaces and social media platforms illegally offer products that may be classified as medicines, including botulinum toxin products and topical anesthetics containing lidocaine. These sales channels may make claims regarding the quality, legality and safety of such products.

Medicinal products must not be purchased through these sales channels. There are no guarantees regarding the origin, composition, safety or authenticity of products obtained from illegal sales channels, and they carry a significant risk of being falsified. The use of such products always poses a significant risk to patient safety. More information is available on Fimea's website under Falsified medicines.

Many products used in aesthetic treatments are medical devices

In addition to medicinal products, a wide range of medical devices is used in aesthetic treatments. If a provider uses, for example, dermal fillers or devices intended to reduce adipose tissue, these are considered medical devices. Where a treatment using a device is intended, for example, to treat a diagnosed disease or to modify human anatomy, the device is considered to have a medical purpose.

Service providers must therefore be able to identify when a product has a medical purpose. Certain categories of products without an intended medical purpose are also regulated as medical devices because they have been assessed as presenting risks similar to those of medical devices and must therefore comply with the applicable regulatory requirements. Many of these products are used in the beauty sector, including devices that emit high-intensity electromagnetic radiation (such as laser radiation, infrared radiation, visible light and ultraviolet radiation) and are intended for use on the human body. In such cases, the treatment must be carried out using a CE-marked medical device.

How can you identify a medical device?

Whether a product is a medical device depends on its intended purpose as defined by the manufacturer. Service providers must always use products in accordance with the manufacturer's instructions for use. In practice, this means that if the intended purpose limits the scope of use of a product or treatment, the user must not use it for any other purpose.

It is also essential to ensure that the product complies with the requirements for CE marking of medical devices, including the applicable safety and performance requirements. The intended purpose of a medical device is defined in Article 2(1) of Regulation (EU) 2017/745 on medical devices (MDR). More information is available on Fimea's website: How can I identify a medical device?

A provider of aesthetic services may have several regulatory roles

A provider of aesthetic services may be considered a professional user of medical devices. A professional user is an operator that uses medical devices in the course of its activities. This may include, for example, a health care service provider or a private company. The definition of a professional user and the obligations applicable to professional users are set out in the Finnish Act on Medical Devices (719/2021, Sections 31–35).

If a clinic providing aesthetic services imports medical devices from outside the European Union, it is regarded as an importer under the legislation. A distributor, in turn, is an operator that supplies medical devices (by selling or distributing them) to other businesses or directly to consumers in Finland. Distributors may source devices either from other EU Member States or from suppliers in Finland.

Importers and distributors are always responsible for ensuring that the medical devices they place on the market comply with the applicable requirements. A product must not be supplied if the importer or distributor has reason to believe that it does not comply with those requirements. It is also important to note that, under Regulation (EU) 2017/745 on medical devices, an operator that places a medical device on the market under its own name, registered trade name or registered trademark is regarded as the manufacturer, regardless of whether the device was originally manufactured outside the European Union. In such cases, the operator assumes all obligations applicable to a manufacturer.

Health care services vs. beauty services

The Act on the Supervision of Social and Health Care Services (741/2023) lays down provisions on the provision of health care services. Among other things, botulinum toxin treatments performed for aesthetic purposes, treatments using Class 4 laser devices, and PRP and HIFU treatments fall within the definition of a health care service under the Act.
To provide health care services, both the service provider and the service unit must be registered in the national Soteri Register of Service Providers. Health care services may only be provided by licensed health care professionals.

Activities may not commence until the registration decision has been issued. Under the temporary provision laid down in Section 5(3) of the Act, a sole service provider may begin operations once all information required for registration has been submitted, the registration application has been filed through Soteri's online service, and the competent authority has received the application. In the case of botulinum toxin treatments, this temporary provision applies only to physicians practicing independently. Registered nurses, public health nurses and midwives may not begin providing botulinum toxin treatments until the registration decision has been issued.

Service providers are always responsible for the safety of their services

Registration under health care legislation applies only to health care services. Many providers of aesthetic treatments also offer services that fall outside the scope of health care, such as dermal filler injections, microneedling, permanent make-up and other skin treatments. The safety of these beauty and body modification services is governed by the Act on the Safety of Consumer Services (185/2025), even when they are provided at premises registered as a health care service unit.

Service providers are always responsible for the safety of the services they provide. This responsibility cannot be transferred to the customer, for example by means of a disclaimer. Service providers must design and deliver their services in a way that ensures customer safety.

Service providers must, among other things:
•    identify the hazards associated with their services and assess the related risks
•    use safe methods and products that are suitable for the intended purpose
•    provide customers with information that is essential for their safety and
•    document and monitor the safety of the services they provide.

Beauty services may also involve the use of devices that emit non-ionizing radiation, such as laser and intense pulsed light (IPL) devices, radiofrequency devices, UV-emitting devices and ultrasound devices. Where such activities do not constitute health care services, the use of these devices is governed by the Radiation Act (859/2018) and STUK Regulation S/11/2024 on cosmetic procedures.

Radiation legislation sets exposure limits for different types of radiation to ensure that customers' exposure remains at a safe level. It also requires customers to be provided with sufficient information about the risks and contraindications associated with treatments, and requires that the devices used comply with the applicable requirements and are accompanied by clear and appropriate instructions for use. Devices that emit very high levels of radiation, such as Class 4 laser devices and HIFU devices, may only be used in health care services.

Be careful what you inject

Products intended for injectable treatments are either medicinal products or medical devices. Cosmetic products must not be used in injectable treatments, as injecting such products may pose a significant risk to the customer's health. The manufacturer or importer is responsible for the safety of a cosmetic product.

The authorities are aware that products marketed in Finland are labelled as cosmetic products even though they are in fact intended for use in injectable treatments. If the packaging states that the product is "for external use only" or indicates that it is intended "for application to the skin", the product must never be injected into the human body. If a product is used contrary to the manufacturer's instructions, the user is responsible for both its use and its safety.

Products intended for lipolysis injections have been found on the market labelled as cosmetic products. The authorities have previously warned both service providers and consumers about these products, and Fimea has classified a number of them as medicinal products.

More information on cosmetic products and the safety of leisure services is available on Tukes' website.

In addition, providers of aesthetic services can make use of the joint online training course Beauty Services and Tattooing, developed by the authorities and available through the Tukes Kampus learning platform.

Further information:

• Act on the Supervision of Social and Health Care Services (741/2023)
• Act on Health Care Professionals (559/1994)
• Act on the Processing of Client Data in Social and Health Care (703/2023)
• Medicines Act (395/1987) – including provisions on the import, distribution and marketing of medicinal products.
• Act on Medical Devices (719/2021) – including provisions on the safety of medical devices, the responsibilities of professional users and the obligations of economic operators.
• Act on the Safety of Consumer Services (185/2025) – including provisions on the safety of services that do not constitute health care.
• Health Protection Act (763/1994)
• Radiation Act (859/2018) – including provisions on the use of non-ionising radiation in consumer services.
• EU Regulation on Cosmetic Products and Act on Cosmetic Products (492/2013)