Dermal fillers, injectable implants, or soft tissue fillers are gelatin-like products intended to be injected under the outer layers of the skin to improve the appearance of wrinkles, depressions, and defects such as scarred tissue, or correct loss of volume on different body parts, allowing a smoother and fuller appearance. These products are considered medical devices by the US FDA.

According to its composition and capacity to be absorbed by the human body, there are temporary (absorbable) and permanent (non-absorbable) dermal fillers.

Absorbable products include hyaluronic acid (HA), hydroxyapatite, and poly-L-lactic acid (PLLA).

The US FDA approved only one non-absorbable product made from polymetylmathacrilate pearls embedded in a collagen solution.

Dermal fillers are approved by the US FDA for the following specific purposes:

• Filling skin folds around the nose and mouth.
• Increasing fullness of lips, cheeks, chin, mandible, and back of the hand.
• Correcting lipoatrophy
• Correcting wrinkles and acne scars

• Bruising
• Redness
• Swelling
• Pain
• Rash
• Itching
• Necrosis of the skin, is a serious complication associated with accidental injection into blood vessels.

No dermal fillers have been approved by the FDA for:

• Breast augmentation
• Buttocks contouring
• Correcting or filling the area between the eyebrows (glabella), nose, perioral, forehead, or neck.
• Spaces between muscles

Injectable silicone remains permanently in the body, hence it is not considered a dermal filler. The US FDA has not approved injectable silicone to be used in aesthetic procedures. Its utilization may be associated with grave and permanent side effects such as infection, disfigurement, and even death.

The FDA has approved a number of botulinum toxin derivatives (e.g. Botox) for the treatment of facial lines and wrinkles. These products are not dermal fillers and are considered injectable drugs. The safety of the combination of dermal fillers and botulinum toxin products has not been scientifically proven.

Source: FDA

Contact us on WhatsApp 997556699 or drop us a line at info@pharmaconsulting.pe to get more information about our Medical Device Registration service in Peru.

In Peru, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) is the National Authority that oversees the medical devices, equipment, pharmaceutical products, personal care, and health products market.

Is it necessary to obtain authorization to operate as a company prior to marketing restricted products?

Yes, according to Bill No. 29459 of 2019, in Peru, companies must register as a pharmaceutical establishment called drogueria with the General Directorate of Medicines, Supplies, and Drugs, before starting the importation and distribution of products. Alternatively, foreign companies that do not wish to operate locally in Peru can contract the services of a registration holder as Pharma Consulting who will act as their representative before our national authorities.

Is it necessary to obtain prior authorization for the marketing of medical equipment, pharmaceutical products, and other health products?

Yes, Bill No. 29459, Supreme Decree No. 016-2011-SA and its amendments establish that, in Peru, companies must have prior authorization for their products, which can be a registration in the case of medical equipment, devices, and pharmaceuticals or a mandatory health notification (NSO) for cosmetics and personal care products.

Are there import controls for medical equipment, devices, pharmaceuticals, or health products?

Yes, Peruvian Customs restricts the entry of medical equipment, devices, medicines, cosmetics, personal care, and other products established in Supreme Decree No. 016-2011-SA, Supreme Decree No. 001-2012-SA, and its amendments. Only companies holding a registration, a current mandatory health notification, or a certificate of these titles are authorized to import this type of product.

Is there a post-market surveillance system in Peru?

Yes, Peru has a Pharmacovigilance and Technovigilance system, established by Supreme Decree No. 013-2014.

Are international standards used to regulate the pharmaceutical market?

Yes, the Regulatory Authority in Peru evaluates the quality and safety parameters of medical equipment, devices, drugs, cosmetics, and other restricted products, taking as reference international standards such as ISO standards, standards published by the FDA, and regulations of the European Community and others of international recognition.

In Peru, only companies registered as droguerias or laboratories can import and distribute medical equipment and devices, medicines, cosmetics, personal care products, and other health products. Alternatively, foreign companies can designate a registration holder to represent them before the Peruvian authorities.

Establishments that sell medical equipment and devices, medicines, and health products must have an operating authorization granted by DIGEMID prior to importing, storing and distributing products.

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 info@pharmaconsulting.pe and quote our health registration service for laser, IPL, and radiofrequency equipment for use in aesthetics in Peru.

In Perú, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) oversees the IVD and medical device market. This agency registers devices, issues operation licenses, inspects manufacturing facilities and warehouses, monitors product testing, and drafts policies and laws regarding medical devices imported to and sold in Perú.

DIGEMID classifies products into three main categories: supplies, medical devices, and IVDs. Bill 29459, Supreme Decree 019-97-SA, Supreme Decree 016-2011-SA, and associated amendments define the regulations for IVDs and medical devices. 

Peruvian regulatory authorities group medical devices according to a four-tier classification system. This classification scheme determines our registration route. Ministerial Resolution 234 of 2017, title II, article 4, outlines medical devices classification in Perú. It includes devices class I, class II, class III, and IV. Devices further divide into active, invasive, and non-invasive.

The classification system for IVDs and medical devices is roughly the same. DIGEMID classifies IVDs into four classes, namely I, II, III, and IV, based on risk.

Regulatory authorities in Perú are not quite flexible on what we can put into a single registration application. There are vast criteria on what can be put together as a family of devices. Different types of devices can’t be grouped together. Devices sold by different manufacturers can’t be grouped together either. Grouping options depend much on the information existing in the Free Sale Certificate (FSC), CFG, and the product manual.

Before you begin the registration process, you’ll need to appoint a local representative, as Pharma Consulting, to communicate with DIGEMID on your behalf. This way, your company can maintain control over the registration. If a distributor is your in-country representative, they will list themself as the owner of the registration.

All registration applications are subject to review from regulatory authorities. Distributors must wait until formal review and approval are complete to begin importing and selling. Timeframes range from 1 to 6 months. If all goes according to plan, DIGEMID will issue a Directorial Resolution approving your device registration. The registration is valid for five years.

Source: Pharma Consulting

Learn more about our medical device market at 997556699 or by mail info@pharmaconsulting.pe

The Directorate of Medicines, Supplies, and Drugs – DIGEMID, has established the mandatory registration of respirators for medical use as of January 1, 2021. This mandate affects institutions and pharmaceutical establishments that import, store, manufacture, or market N95, KN95, FFP2, FFP3 respirators for medical use, and the like, as they are considered class I medical devices.

Individuals and businesses not registered with DIGEMID will not be permitted to import and distribute this kind of products.

This new requirement will take effect on January 1, 2021.

The requirements to register respirators for medical use are established by DIGEMID. You can learn more about the procedure by clicking here.

The N95 respirator is a respiratory protection device designed to achieve a good facial fit and very efficient filtration of airborne particles. The N95 designation means that, when carefully tested, the respirator blocks at least 95 percent of very small particles (0.3 microns). If properly fitted, the filtration capabilities of N95 respirators exceed those of surgical masks.

The KN95 respirator is not resistant to oily airborne particles. It is recommended to use it in conjunction with a face shield.

FFP2 and FFP3 particulate respirators are not resistant to fluids. It is recommended to use them in conjunction with a face shield.

Also called a three-fold mask or disposable mask, it is a medical material that covers the mouth and nose, and provides a barrier to minimize the direct transmission of infectious agents between medical personnel and patients.

Contact us at 997556699 or info@pharmaconsulting.pe to learn more about medical respirators registration.

Source: DIGEMID

The National Authority of Pharmaceutical Products, Medical Devices, and Health Products has reduced the maximum period of evaluation for the inscription and reinscription of medical devices in the Peruvian sanitary registry.

Medical Devices (MD) Class I, low risk: Up to thirty (30) calendar days.

Medical Devices (MD) Class II, moderate risk: Up to sixty (60) calendar days.

Medical Devices (MD) Class III, high risk: Up to ninety (90) calendar days.

Medical Devices (MD) Class IV, critical risk: Up to ninety (90) calendar days.

Due to this modification to the current regulations, manufacturers and importers are expected to reduce the time to market their products.

All medical device registration applications are subject to review from regulatory authorities. Distributors must wait until formal review and approval are complete to begin importing and selling. Timeframes range from 1 to 6 months. If all goes according to plan, DIGEMID will issue a Directorial Resolution approving your device registration. The registration is valid for ten years.

Learn more about MD registration in Perú and contact us at 997556699 or by mail info@pharmaconsulting.pe

According to D.R. No. 033-2017-DIGEMID-DG-MINSA, published early this year, DIGEMID issued a list of medical devices that may be marketed directly to end-users. This document does not list every medical device but establishes a criterion based on MD risk classification.

Laboratories and droguerías (pharmaceutical establishments) may directly sell all classes of medical devices to healthcare institutions, health professionals, and patients.

Biomedical equipment may be sold only to health professionals and healthcare institutions like hospitals and clinics.

Class III (high risk) biomedical equipment, may only be sold to health professionals and healthcare institutions.

Self-tests, in vitro diagnostic reagents, and laboratory equipment may only be sold to healthcare institutions.

Self-tests, in vitro diagnostic reagents, and laboratory equipment may only be sold to healthcare institutions.

The seller must keep proof of payments (invoices or tickets) on record. Additionally, for health professionals, a copy of the registration card or registration number must be kept; and for patients, a copy of the prescription.

Contact us at 997556699 or info@pharmaconsulting.pe to learn more about medical device registration.

Source: DIGEMID

The Directorate of Medicines, Supplies, and Drugs – DIGEMID, issued a list of medical devices that can be marketed directly to end-users. In order to acquire a particular product, users must present a medical prescription, if required.

Class I (low risk), class II (moderate risk), class III (high risk), and class IV (critical risk) biomedical equipment, only to be sold to health professionals and institutions that provide health services (IPRESS).

Class I (low risk), class II (moderate risk), class III (high risk), and class IV (critical risk) medical devices, only to be sold to health professionals and institutions that provide health services (IPRESS).

Class I (low risk), class II (moderate risk), class III (high risk), and class IV (critical risk) medical devices, only to be sold to patients, upon presentation of a medical prescription.

Class I (non-sterile, low risk) only to be sold to commercial establishments.

Self-tests, reagents, and laboratory equipment.

Contact us at 997556699 or info@pharmaconsulting.pe to learn more about medical device registration.

Source: DIGEMID