Perú has over 33 million residents, and is a strong, developing market for foreign manufacturers. Our local industry does not satisfy our population demands and we depend heavily on import products mainly from China, US, India, Israel, Brazil, Colombia, among other industrialized countries.

DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), our market regulator, is responsible for the control and regulation of medical devices, IVD devices, medicines, biologics, dietary supplements, cosmetics, personal care products, and house cleaning products.

Imported products must be registered with DIGEMID before entering our market. Cosmetics registrations should be renewed every seven years, and all other products every five years.

After years of helping manufacturers from all over the world, we’ve learned that most of them prefer to trust their registrations to us rather than a third party, such as a local distributor or importer. Few companies opt for opening a local office due to high fixed costs and complex local procedures. Despite the decision you make, Pharma Consulting is ready to fully support you regulatory compliance in our market.

What is your business model for our market? Regulatory strategy is just a part of the bigger picture. Finding trustworthy local distributors, competing with our informal market and establishing long-lasting partnerships are among the most frecuent difficulties our clients face. Please, consider checking out this article by Ernst & Young covering commercial strategy consideratios for growth.

Registering an entire product portfolio may not be the best approach due to high market entry costs and effort. We advise our clients to narrow their focus to a small market, and start with market-leading products.

As your regulatory representative and registration holder, our task is to ensure a swift access to the Peruvian market. We will clarify the requirements outlined in local guidance documents and regulations, propose practical solutions to meet them, assess your technical and regulatory documentation, and elaborate fully compliant registration dossiers. 

We will outline a regulatory strategy for your products, and obtain the registrations in a timely and cost-efficient manner. As yout PRH we’ll keep you updated with relevant regulation changes. The registrations will remain always under your control.

After obtaining market clearance, your business will be ready to deploy a successful marketing strategy.

In Peru, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) is the National Authority that regulates the food suplements market.

A food supplement is any product that contains vitamins, minerals, amino acids, vegetal extracts, enzymes, chemical substances such as glucosamine, methylsulfonylmethane, hyaluronic acid, flavonoids, probiotics, and other nutritional substances intended to supplement our normal daily diet or reduce the risk of developing diseases. Dietary supplements must be marketed in a defined pharmaceutical dose form as tablets, capsules, powders, pearls, gel capsules, and syrups, among others.

Food supplements are not medicinal products. Therefore, their use is not intended to treat or prevent diseases in humans or to modify physiolofical functions. Manufacturers of dietary supplements must not claim diagnostic, therapeutic, or preventive properties. For example, “reduces high LDL”, “prevents heart disease”, “boosts the immune system”, and the like.

Food supplement are classified as pharmaceutical products, that is the same group as drugs, and medicinal gases.

To import and sell food supplements, first you must register as a pharmaceutical establishment with our national regulatory agency or appoint a legal representative based in the country or Peruvian Registration Holder (PRH) as Pharma Consulting. This way, your registrations in Peru are under your control. If you decide to end the relationship with your commercial distributor at any point, you would not be required to re-register your products.

When registering an imported, your designated registration holder must submit a registration application to Digemid. This application includes technical and regulatory documentation. Digemid evaluates the application to ensure the product meets their quality, safety, and efficacy standards. Please, consider that approvals from the European Union or the United States do not automatically guarantee registration in Peru.

Our regulatory framework is rigorous, aiming to gurantee the quality, safety, and effectiveness of food supplements available in the peruvian market. It is essential to have a thorough understanding of the guidelines established by Digemid to avoid any potential compliance issues, and facilitate the registration process for your products.

As your PRH, we are committed to acting honestly, fairly, professionally, and in the best interests of your business.

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

Calling Peru from abroad? From North America, please use 011 51 997556699, from Europe, and most APAC countries use 00 51 997556699

The U.S. Food and Drug Administration (FDA) has found that many bodybuilding (workout) products may contain anabolic steroids or steroid-like substances in their composition. Such ingredients included illegally or not declared by manufacturers may pose serious health risks to consumers, for example, severe liver (hepatic) injury, kidney damage, heart attack, stroke, pulmonary embolism, deep vein thrombosis, severe acne, hair loss, irritability, aggressiveness, depression, among others.

These types of products are promoted as concentrates with hormones or substitutes for anabolic steroids to increase muscle mass in a short time; however, they may contain steroids in their composition.

The FDA does not evaluate the efficacy or safety of these products before they reach the consumer market. In addition, they are usually sold online, in gyms, or by catalog, which makes control difficult. In Peru, all dietary products or supplements are rigorously evaluated by the General Directorate of Medicines, Supplies, and Drugs (Digemid) before and after entering the country, through a process called registration, in which the complete composition of the product is declared, and the nutritional or physiological effect of each active ingredient is assessed.

Source: FDA

Contact us on WhatsApp by clicking here or drop us a line at info@pharmaconsulting.pe to get more information about our Dietary Supplement registration service in Peru.

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.

The General Directorate of Medicines, Supplies, and Drugs (DIGEMID), during the first “Virtual technical meeting on the registration process of nutritional supplements and sweeteners”, established some criteria to be taken into account by users interested in registering these products.

• The registration is granted by product name, pharmaceutical form, amount of active ingredient, manufacturer, and country of origin.

• Technical specifications of the finished product. The technical specifications of the product must include the tests carried out on the finished product

• Certificate of Free Sale (FSC) issued by the competent authority in the country of origin

• Product formula indicating its basic and secondary ingredients

• Stability studies

• Labeling projects and package label

• Good Manufacturing Practices (GMP) Certificate

From now on, the registration or re-registration of dietary supplements in the General Directorate of Environmental Health (DIGESA) will not be allowed.

Authorization is requested virtually to the Ministry of Health.

Source: DIGEMID

Contact us at 997556699 or by mail info@pharmaconsulting.pe and learn more about dietary supplement and sweeteners registration in Peru.

The FDA warned 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent chronic diseases, like diabetes mellitus. The Administration urges consumers not to consume products that have not been evaluated by the FDA to be safe or effective for their intended use.

In Perú, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) oversees the dietary supplement market. The agency registers nutritional supplements, inspects manufacturing facilities and warehouses, monitors product testing, and drafts policies and laws regarding supplements imported to and sold in Perú.

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.