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.

Preliminary results of a randomized study with adult patients older than 65 years. The researchers found that over a 3-year period of treatment, patients who received multivitamins such as vitamin B12, folate, vitamin D, and other micronutrients reduced fared better than those who received placebo. Investigators estimated that multivitamins were slowing cognitive aging by 60% over the span of the study, reducing cognitive aging by 1.8 years.

The subgroup of patients with a history of underlying cardiovascular disease appeared to have a particularly strong benefit from multivitamins.

If the findings are confirmed, multivitamin supplementation may become a simple, safe, and accessible intervention to protect brain health in older adults.

This group of products includes vitamins, minerals, amino acids, vegetal extracts, enzymes, chemical substances as glucosamine, methylsulfonylmethane, hyaluronic acid, flavonoids, probiotics, and any other nutritional substance intended to complement our daily diet or reduce the risk of developing diseases. Dietary supplements must be marketed in a defined pharmaceutical dosage form as tablets, capsules, powders, pearls, gel capsules, syrups, among others.

Sweeteners or sugar substitutes are products specifically formulated to give a sweet flavor to food and beverages without calories. This group of products must be consumed orally.

Manufacturers of dietary supplements and sweeteners must not claim diagnostic, therapeutic nor preventive properties. For example, “reduces high LDL”, “prevents heart disease” or “boost the immune system”, and the like.

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

Source: Medscape

Emergency decree No. 0-26-2020 established various exceptional and temporary measures to prevent the spread of the new coronavirus (COVID-19) in Perú. Our national regulator, DIGEMID, has established the prioritization of several administrative procedures:

• Exceptional authorizations for individual treatment of patients, which grants the bearer authorization to import medicines, biological products, and medical devices.

• Registration of pharmaceutical products related to preventing, diagnosing, and treating COVID-19, and other high-priority diseases as dengue, and Guillain Barré syndrome.

• Registration of medical devices and in-vitro diagnostic medical devices related to preventing, diagnosing, and treating COVID-19, and other high-priority diseases as dengue, and Guillain Barré syndrome.

• Registration of household cleaning products and disinfectants.

Imported cosmetic products that are marketed in the Andean subregion must comply with cGMP according to the new regulations and international standards.

• Examination gloves.

• Surgical gloves.

• Reagent kits for molecular tests (new coronavirus)

• Quick hygiene tests for surfaces.

• Rapid IgG and IgM antibodies tests.

• PCR type molecular biology kits.

• Products for oral and dental hygiene: toothpaste, mouthwashes, rinses.

• Soaps and detergents.

• Household hygiene products.

• Surface disinfectants (active against the new coronavirus)

• Absorbent damp cloths.

• Hand sanitizer.

• Medicinal alcohol solutions.

• Non-sterile mask o face mask.

• Disposable mask.

• Disposable protective mask, non-sterile, N-95 type.

• Single-use gown for patients, non-sterile.

• Single-use gown, non-sterile.

• Reusable patient gown, non-sterile.

• Non-sterile surgical caps.

• Non-slip insole shoes.

Contact us at 997556699 or by mail info@pharmaconsulting.pe and learn more about product registration in Perú.

Source: DIGEMID

The General Secretariat of the Andean Community of Nations (CAN), through resolution No. 2206, approved the Andean technical regulation of Good Manufacturing Practices applicable to cosmetic products, which must be complied with by companies or establishments that manufacture, package, condition, or manufacture cosmetic products commercialized in the territories of the CAN member countries (Colombia, Peru, Ecuador, and Bolivia).

Imported cosmetic products that are marketed in the Andean subregion must comply with cGMP according to the new regulations and international standards.

GMPs are a set of standards, processes, human resources, infrastructure, and technical procedures, the application of which must guarantee the quality and controlled production of each batch of cosmetic products, minimizing contamination factors within the production chain in order to obtain a safe product to be used by the population.

• Cosmetics for the skin: makeup, makeup remover.

• Cosmetics for lips: lipsticks, balms.

• Cosmetics for grooming and personal hygiene: soaps, scrubs.

• Nail cosmetics: nail polish, acrylic nail systems, polish removers.

• Perfumery cosmetics: lotions, perfumes.

• Hair cosmetics: shampoo, conditioners, hair dyes.

• Products for oral and dental hygiene: toothpaste, mouthwashes, rinses.

• Products for and after shaving: lotions, shaving cream.

• Products for tanning, sun protection, and self-tanners.

• Depilatories: liquid wax, roll-on wax.

• Products for skin whitening.

• Deodorants and antiperspirants.

Learn more about GMP for cosmetic products and contact us at 997556699 or by mail info@pharmaconsulting.pe

Source: Comunidad Andina de Naciones

Estimates of the Peruvian Cosmetic and Hygiene Guild (COPECOH) indicate that the market for personal hygiene and cosmetic products would mobilize up to 9.8 billion soles during this year.

The products with the greatest demand, mainly by women, are fragrances, hair products, skincare products, and makeup.

In terms of consumer channels for these products, the preferred ones are retail sales, direct sales, and virtual stores.

• Cosmetics for the skin: makeup, makeup remover.

• Cosmetics for lips: lipsticks, balms.

• Cosmetics for grooming and personal hygiene: soaps, scrubs.

• Nail cosmetics: nail polish, acrylic nail systems, polish removers.

• Perfumery cosmetics: lotions, perfumes.

• Hair cosmetics: shampoo, conditioners, hair dyes.

• Products for oral and dental hygiene: toothpaste, mouthwashes, rinses.

• Products for and after shaving: lotions, shaving cream.

• Products for tanning, sun protection, and self-tanners.

• Depilatories: liquid wax, roll-on wax.

• Products for skin whitening.

• Deodorants and antiperspirants.

Contact us at 997556699 or by mail info@pharmaconsulting.pe and learn more about cosmetic products registration in Perú.

Source: COPECOH

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

The president of the Pharmaceutical Industries Association (ADIFAN), José Silva, explained that Peruvian laboratories are at disadvantage compared to foreign manufacturers who are favored by tariff exemptions.

Due to this situation, Peruvian laboratories manufacture less quantity of medicines, causing up to 70% of medicines in Perú to be imported and only the remaining 30% to be national production.

In this regard, the National Institute of Research and Statistics (INEI) has established that the production of the national pharmaceutical industry has been declining from 2013 until 2017 when it grew by 10%.

The president of ADIFAN said that Perú imports medicines for an amount of USD 1.3 billion and only exports USD 69 million.

Source: Gestión

The Peruvian government published the regulation of the Emergency Decree No. 007-2019 that guarantees access to generic drugs, biological products, and medical devices as an essential part of the right to health.

• Aminotriptiline

• Amlodipine

• Amoxicillin

• Amoxicillin/clavulanate

• Atorvastatin

• Azithromycin

• Beclometasone

• Captopril

• Carbamazepine

• Cefalexin

• Clindamycin

• Clonazepam

• Clorphenamin

• Clotrimazole

• Enalapril

• Phenytoin

• Fluconazole

• Fluoxetine

• Glibenclamide

• Ibuprophen

• Loratadine

• Losartan

• Metformin

• Naproxen

• Omeprazole

• Acetaminophen

• Prednisone

Learn more about the Peruvian pharmaceutical market at 997556699 or by mail info@pharmaconsulting.pe

Pharma Consulting warns the general public about the danger of acquiring pharmaceutical products, medical devices, and other health products in unauthorized establishments or through advertisements on social networks and e-commerce websites.

We express our concern about an increase in advertisements for products that lack the registration required, advertisements that proclaim unauthorized benefits, or therapeutic properties that deceive consumers and promote self-medication. The products commonly marketed in social networks and internet ads as “fat burners”, “weight loss pills”, “hair loss prevention pills”, “sweeteners”, “energizing” drinks, among others.

The use of these illegal or adulterated products poses a serious risk to health since in many cases they are fakes or mixtures with chemical substances not suitable for human consumption.

Pharma Consulting reminds consumers not to be surprised by advertisements for products that offer unrealistic benefits.

Contact us at 997556699 or by mail info@pharmaconsulting.pe to learn more about product registration in Perú.

Source: DIGEMID

The Indian pharmaceutical industry, in 2016, exported a total of USD 41 million to the Peruvian market, becoming the sixth largest supplier of pharmaceutical products in Peru.

Ten health institutions in Peru represent 41% of imports of pharmaceutical products. The Ministry of Health ranks first with USD 66 million, representing 9% of the total imported products at the end of 2016. Of these purchases, 13% (USD 8.4 million) came from pharmaceutical companies in India.

The Peruvian government published Emergency Decree No. 007-2019 that guarantees access to generic drugs, biological products, and medical devices as an essential part of the right to health.

• Aminotriptyline

• Amlodipine

• Amoxicillin

• Amoxicillin/clavulanate

• Atorvastatin

• Azithromycin

• Beclomethasone

• Captopril

• Carbamazepine

• Cephalexin

• Clindamycin

• Clonazepam

• Chlorphenamine

• Clotrimazole

• Enalapril

• Phenytoin

• Fluconazole

• Fluoxetine

• Glibenclamide

• Ibuprofen

• Loratadine

• Losartan

• Metformin

• Naproxen

• Omeprazole

• Acetaminophen

• Prednisone

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