According to a new report by the Emergo Group, a global healthcare consultancy, Peru’s medical regulatory agency has introduced new draft regulations to overhaul the country’s existing classification system.
In its report, the Emergo Group detailed that the new classification scheme by the Dirección General de Medicamentos y Drogas e Insumos (DIGEMID) will resemble that of the European Union. In particular, it will resemble the European Medical Device Directive Annex IX. According to the Emergo Group, current classifications for medical devices and healthcare products in Peru are based on classification lists. However, this can make it difficult for registrants to determine the proper classification for their devices.
A link to DIGEMID’s draft regulation page is available in the references below (link only available in Spanish). The Emergo Group has stated that it will provide further details about the new classification scheme as they become available.
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