Two categories of change: notification and DRCPFA authorisation, filed on F-AS-f-10
Changes to a device inscription fall into two categories — those requiring notification and those requiring authorisation from the DRCPFA — and are filed on form F-AS-f-10, 'Solicitud de Actualización de Inscripción Sanitaria de Productos Afines'. NT-37 Art. 6 enumerates the change types, including change of holder (6.1), change of the manufacturer's or holder's corporate name (6.2) and addition of an alternative manufacturing plant (6.12). All documentation must be in Spanish, with official translations for foreign documents.
- Adding an alternative manufacturing plant for the same manufacturer at a different site, keeping the same presentation and labelling, keeps the same inscription number but requires the manufacturing-guarantee certificate at Art. 6.12.6.
Spanish source (Guatemala). Translation: "There are two categories of modifications to the Health Inscription, those requiring a notification and those needing an authorisation from THE DEPARTMENT, per Form F-AS-f-10 of the current version Application for Update of Health Inscription of Related Products." The same chapter adds: 'Cuando se realicen cambios en los dispositivos médicos, el interesado debe solicitar su aprobación a la autoridad adjuntando los requisitos para el trámite de las modificaciones que se enumeran a continuación.'