The Directorate of Medicines, Supplies, and Drugs – DIGEMID, issued a list of medical devices that can be marketed directly to end-users. In order to acquire a particular product, users must present a medical prescription, if required.
Biomedical Equipment
Class I (low risk), class II (moderate risk), class III (high risk), and class IV (critical risk) biomedical equipment, only to be sold to health professionals and institutions that provide health services (IPRESS).
Medical Devices
Class I (low risk), class II (moderate risk), class III (high risk), and class IV (critical risk) medical devices, only to be sold to health professionals and institutions that provide health services (IPRESS).
Class I (low risk), class II (moderate risk), class III (high risk), and class IV (critical risk) medical devices, only to be sold to patients, upon presentation of a medical prescription.
Class I (non-sterile, low risk) only to be sold to commercial establishments.
In Vitro Diagnostic Medical Devices
Self-tests, reagents, and laboratory equipment.
Contact us at 997556699 or info@pharmaconsulting.pe to learn more about medical device registration.
Source: DIGEMID
Peru registration holder