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.

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

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