Treatments using non-ionising radiation and sound: FAQs
Here you can find answers to frequently asked questions about treatments using non-ionising radiation and sound.
Treatments
For treatments that are performed invasively with needles (needle epilation, RF microneedling, RF needle mesotherapy), there are no requirements stipulated by the responsible body. Provided such treatments are not regulated by cantonal provisions, they are currently not subject to the requirement to obtain a certificate of competence.
It should be noted, for example, that certain cantons (such as the Canton of Zurich) distinguish between cosmetic application (puncture depth up to 0.5 mm) and medical application (puncture depth from 0.5 mm).
The use of medical microneedling is reserved for physicians who hold a licence to practise in the respective canton.For treatments pursuant to Annex 2, number 1, that are performed invasively with needles (needle epilation, in which an electrode is inserted into the hair canal to destroy the hair root galvanically; RF microneedling; RF needle mesotherapy), there are no requirements laid down by the responsible body. Provided such treatments are not governed by cantonal provisions, they are currently not subject to the requirement to obtain a certificate of competence.
Only the treatments listed in Annex 2, numbers 1 and 2, of the O-NIRSA fall within its scope.
This means that all treatments not listed under the O-NIRSA do not fall under its scope.Examples of treatments that do not fall under the O-NIRSA, even if performed with devices that use radiofrequency, ultrasound, cold, light or laser, include:
- Therapeutic treatments
- Pain treatments
- Rehabilitation
- Fitness and training
- Peripheral nerve stimulation (PNS)
- Transcranial magnetic stimulation (TMS)
- Whole-body stimulations
- Tooth whitening (with ultrasound)
Multifunctional devices with several functions (e.g. ultrasound and radiofrequency) may be used, provided they are only used to perform treatments for which the person holds a certificate of competence.Techniques used for treatments that are reserved for physicians or prohibited in principle are not permitted. For further information, see the section “Treatments”.
A certificate of competence is required for the following treatments (Annex 2 No 1 O-NIRSA):
- acne;
- cellulite and subcutaneous fat;
- telangiectasia (couperose), haemangiomas (benign vascular lesions) and spider naevi measuring less than or equal to 3 mm, with the exception of treatments on the eyelids or in the peri-ocular area (up to 10 mm), which are subject to medical supervision;
- wrinkles;
- onychomycosis;
- Removal of: hair, permanent make-up by laser, and tattoos by laser. Treatments on the eyelids or in the periocular area (up to 10 mm) are subject to medical supervision.
- General definition
Persons are considered directly instructed practice personnel if they are employed by a physician and work under his or her direct instruction, supervision and responsibility. The physician bears full responsibility and must therefore be physically present in the practice during treatments.
- What conditions must be met in medical facilities?
If directly instructed personnel are employed in a medical facility (e.g. hospital), the contracts between the medical facilities, the physicians and the practice personnel, as well as the work schedules, must be structured in such a way that the medical personnel are always under the direct instruction, supervision and responsibility of the physicians, who must be physically present on site. Third parties who, for example, rent premises in a medical practice or medical facility but work independently, are not considered directly instructed practice personnel. Such persons may only perform treatments in accordance with Article 5(1) of the O-NIRSA with a certificate of competence.
- When are the requirements not fulfilled?
Supervision of practice personnel by physicians is not fulfilled if:
- the physicians are not physically present during treatment, but can only be reached via communication devices;
- there are no employment contracts between the physicians and the practice personnel, and the cooperation is regulated in another way.
The following techniques and procedures (Annex 2 No. 2 O-NIRSA):
- High-intensity focused ultrasound (HIFU)
- Ablative lasers
- Long-pulsed Nd:YAG lasers
- Photodynamic therapies combined with the application of phototoxic substances or medicinal products
- Laser lipolysis
Treatments subject to medical supervision (Annex 2 No. 2 O-NIRSA) include:
- actinic and seborrhoeic keratosis;
- age spots;
- angiomas / large haemangiomas (greater than 3 mm);
- dermatitis;
- eczema;
- genital warts;
- fibromas;
- port-wine stains;
- keloids;
- melasma;
- psoriasis;
- syringomas;
- sebaceous gland hyperplasia;
- varicose and spider veins;
- vitiligo;
- warts;
- xanthelasma.
- Treatments on the eyelids or in the periocular area (up to 10 mm) for:
- Removal of permanent make-up
- Removal of tattoos and telangiectasias (couperose)
- Treatment of spider naevi and haemangiomas
Only the treatments listed in Annex 2, numbers 1 and 2, of the O-NIRSA fall within its scope. This means that all treatments not listed under the O-NIRSA do not fall under its scope.
Examples of treatments that do not fall under the O-NIRSA, even if performed with devices that use radiofrequency, ultrasound, cold, light or laser, include:
- Therapeutic treatments
- Pain treatments
- Rehabilitation
- Fitness and training
- Peripheral nerve stimulation (PNS)
- Transcranial magnetic stimulation (TMS)
- Whole-body stimulations
- Tooth whitening (with ultrasound)
For treatments pursuant to Annex 2, number 1, that are performed invasively with needles (needle epilation, in which an electrode is inserted into the hair canal to destroy the hair root galvanically; RF microneedling; RF needle mesotherapy), there are no requirements laid down by the responsible body. Provided such treatments are not governed by cantonal provisions, they are currently not subject to the requirement to obtain a certificate of competence.
Devices
“NiSV-free” means that a specific cosmetic device does not fall under the German NiSV Ordinance (Ordinance on Protection against Harmful Effects of Non-Ionising Radiation in Human Applications).
In Germany, such a device may be used without a certificate of competence.
In Switzerland, however, the use of all devices emitting non-ionising radiation for all treatments falling within the scope of O-NIRSA requires a certificate of competence, also for the use of devices labeled as NiSV-free.The Ordinance to the Federal Act on Protection against Non-Ionising Radiation and with Regard to Sound Levels (O-NIRSA; SR 814.711) regulates only treatments that use non-ionising radiation, sound or cold and sets out the requirements for persons who perform these treatments.
If a treatment is carried out in accordance with Annex 2, numbers 1 and 2 of the O-NIRSA and a device that uses non-ionising radiation, sound or cold is applied, it can be assumed that the treatment falls under the O-NIRSA.Ablative lasers typically use long wavelengths (> 2000 nm), which make it possible to vaporise (evaporate) and thereby remove water-rich skin cells in a controlled manner.
Any person who installs, uses or maintains a product must comply with the manufacturer’s safety requirements and ensure that human health is not endangered or only minimally endangered (Art. 3 para. 1 NIRSA). In concrete terms, this means that the device must be maintained in accordance with the user manual (specifically the section “Maintenance schedule”).
Device conformity can be determined using the factsheet on NIR and sound products for cosmetic treatments (see pages 3–4).
The fractional thulium laser, with a wavelength of approximately 1920 nm, is considered a non-ablative laser.
It must be taken into account that there are two categories of ultrasound devices:
- Category 1 – Ultrasound for professional or commercial use, not under the medical reservation; and
- Category 2 – Ultrasound under the medical reservation
The criterion for distinguishing between HIFU and ultrasound treatments permitted for professional or commercial use is defined by the requirements for professional and commercial ultrasound devices set out in the IEC standard “Household and similar electrical appliances – Safety – Part 2-115: Particular requirements for skin beauty care appliances” IEC 60335-2-115:2021 | IEC Webstore.
If ultrasound devices for cosmetic treatments comply with these requirements, they may be used professionally or commercially without the medical reservation.
If the devices do not meet the requirements of the above-mentioned standard, they may be used only by physicians or by instructed practice personnel (for the definition of instructed practice personnel, see the question “What does ‘under the direct instruction, supervision and responsibility of physicians’ mean / under the medical reservation?”).To determine whether a device complies with IEC 60335-2-115:2021, the device specifications must be checked, or the manufacturer must be contacted to clarify the matter.
Obtaining a certificate of competence / Persons holding certificates of competence
For the certificates of competence Laser acupuncture and Nail fungus, training as a TCM acupuncturist/ a diploma in podiatry (EFZ or HF) is required.
Certificates of competence in the cosmetic field (i.e. the following certificates: hair removal by laser, hair removal by IPL, permanent make-up and tattoo, skin and pigmentation, fat pads and cellulite) can be obtained in two ways:
- In the regular version, there are no prerequisites.
- In the shortened (extended) version, one must hold either a Federal VET Diploma (EFZ) in cosmetics, or a Federal Diploma of Professional Education and Training (FA / HFP), or a Diploma in dermatopigmentology at a higher professional level.
More detailed information can be found in section 3.1 of the examination regulations of the responsible body (in German).
Only complete certificates of competence may be completed at one examination centre.
This means that it is not possible, for example, to complete the Technologies module at one centre and then take the remaining modules at another. Once a certificate of competence has been obtained, the TKS modules (modules on treatment-specific knowledge and skills) leading to the acquisition of further certificates of competence may be completed at another examination centre. That centre then issues the new certificate of competence.Appeals are examined in the first instance by the examination board of the respective examination centre, which decides on the appeal. The Federal Office of Public Health (FOPH) is not responsible for processing such cases. In practical terms, this means that in the event of an appeal, you must contact the examination centre, not the FOPH.
Examination centre
To become an examination centre, an application with all required documents must be submitted. Further information on the forms to be completed, documents to be submitted and requirements can be found under: Information for prospective examining bodies.
The FOPH has drawn up guidelines for preparing applications, which are also available on the FOPH website: Guidelines for the submission of applications for examination centres – O-NIRSACertificates of competence can only be completed in full at one examination centre. This means that it is not possible, for example, to complete the Technologies module at one centre and then take the other modules at another centre.
Once a certificate of competence has been obtained, the CCT modules (modules on treatment-specific knowledge and skills) leading to the acquisition of further certificates of competence may be completed at another examination centre. That centre will then issue the new certificate of competence.
The following requirements must be met for trainers, examination experts and members of the examination committee:
- professional qualifications for teaching the content of the training plans. The minimum requirement is a Federal VET Diploma (EFZ) in the relevant professional field, or proof of an equivalent qualification;
- at least three years of professional experience in the relevant field;
- the necessary language skills to be able to train and/or examine participants (minimum level B2).
Trainers must also have at least two years of teaching experience.
Trainers who, within the framework of the CCT module, perform practical treatments on persons and thus practise such treatments professionally must hold the corresponding certificate of competence. Alternatively, these treatments may be carried out under the direct supervision and responsibility of a physician.
Trainers who provide online teaching must have the necessary skills to use online platforms.(See Chapter 4.1 of the Guidelines for the submission of applications for examination centres – O-NIRSA)
The examination centres authorised to conduct certificates of competence are listed in Annex 1 of the Ordinance of the FDHA on Certificates of Competence for Cosmetic Treatments with Non-Ionising Radiation and Sound (SR 814.711.32), in German.
The list of examination centres where certificates of competence can be obtained is also available on the FOPH website: List of examination centres.This list also indicates the teaching and examination languages in which the certificates of competence are conducted.
Centres that are not included on these lists are NOT authorised to issue certificates of competence.
Further information on obtaining a certificate of competence can be found here: Information for persons who wish to acquire a certificate of competence.
Federal funding for preparation for federal examinations
Persons attending a course that prepares for a federal examination are financially supported by the Confederation. An application must be submitted to the SERI for this purpose. Further information is available on the SERI website: Federal contributions for courses preparing for federal examinations.
However, the training and examination for the certificate of competence under the O-NIRSA are not federal examinations and therefore do not qualify for federal contributions. There are, however, cantonal regulations on this matter. More detailed information is available from the canton of residence.
Inspections and violations under the O-NIRSA
The cantonal enforcement authority is responsible for on-site inspections. Depending on the canton, the competent authority may vary. The competent authorities for each canton can be found here: