A device for use in aesthetic medicine is classified biomedical, active, non-invasive, or minimally invasive device that acts through the administration or exchange of energy in the form of non-ionizing radiation, to or from the human body. Most of the equipment in this category belongs to Class II: moderate risk.

The use of this equipment is the responsibility of specialist medical professionals with the necessary technical knowledge. Additionally, patients and staff should always wear personal protective equipment during treatments.

• Intense pulsed light (IPL) equipment

Acts by applying light of high intensity and short duration (pulses) to the skin, causing the phenomenon of selective photothermolysis, or destruction by heat.

The main applications of IPL equipment are permanent hair removal, photorejuvenation, removal or attenuation of pigment spots caused by aging or solar radiation, rosacea, blood vessel treatments, removal or attenuation of telangiectasias (blood vessels visible on the skin), onychomycosis (fungal nail infection), attenuation of wrinkles, scars and stretch marks.

• Radiofrequency equipment

It works by transferring radiofrequency energy in the form of heat to the deeper layers of the skin to stimulate the production of collagen (collagen genesis) and the destruction of fat cells (lipolysis).

The main applications of radiofrequency equipment are rejuvenation, attenuation or elimination of wrinkles, flaccidity, and cellulite. It can be applied to all skin types and to any part of the body such as the skin of the face, neck, abdomen, thighs, and buttocks.

• Fractional laser

Acts by applying radiofrequency energy to a depth equivalent to a fraction of a millimeter within the skin, causing microscopic lesions that, upon healing, acquire a rejuvenated and firmer appearance.

Two types of fractional laser are available: fractionated laser with ablative or vaporizing effect and fractionated laser with non-ablative or coagulant effect.

The main applications of fractional laser equipment are rejuvenation, removal, or attenuation of acne scars, surgical scars, wrinkles, and stretch marks.

The import and distribution of this type of biomedical equipment can only be carried out by a licensed pharmaceutical establishment (droguería) authorized by DIGEMID for the import, commercialization, storage, and distribution of medical devices.

For this procedure, the application form must be submitted as a sworn statement, attaching the documentation indicated in subsection a) of Article 20 of Supreme Decree No. 016-11-SA. In addition, you must attach the documents detailed in number V of the sworn statement to be submitted.

The most important necessary documents are:

• Technical specifications of the equipment.

• Instructions for use or user manual.

• A current ISO 13485 certificate or document that certifies compliance with quality standards specific to the type of medical device, for example, IEC electrical safety certificate.

• A certificate that guarantees the safety, quality, and performance of the device.

El registro sanitario se solicita de manera virtual ante el Ministerio de Salud mediante la Ventanilla Única de Comercio Exterior (VUCE).

Source: ANMAT

Contact us via WhatsApp at 997556699 or by email at [email protected] and quote our health registration service for laser, IPL, and radiofrequency equipment for use in aesthetics in Peru.