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.

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