The Dirección General de Medicamentos, Drogas e Insumos (DIGEMID), Peru’s medical device market regulator, has published draft regulations (links to page in Spanish) to overhaul the country’s device classification system.

Under the draft regulation, medical device classification in Peru would resemble the European Medical Device Directive Annex IX; DIGEMID’s current classification system for devices is generally based on classification lists, but can prove unclear for registrants.

Emergo Group will provide further details as we learn them.