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.
Contact us at 997556699 or info@pharmaconsulting.pe to learn more about medical device registration.
Source: DIGEMID
Peru registration holder