DIGEMID allows direct selling of medical devices to patients, healthcare institutions, professionals, and retailers

Pharma Consulting — Fri, 20 Sep 2019 23:51:20 +0000

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.

Medical Devices Class I, II, III, and IV

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

Biomedical Equipment

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

Biomedical Equipment with Controlled Technology

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

In Vitro Diagnostic Medical Devices

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

Distributors and retailers

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.

Source: DIGEMID

E-commerce of pharmaceutical products in social networks and web pages

Pharma Consulting — Wed, 21 Aug 2019 04:50:58 +0000

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.