Dominican Republic medical device regulatory resources

'Tiempo de respuesta: 90 días laborables' is the figure DIGEMAPS publishes for the sanitary registration of sanitary products. It is a service standard, not a statutory maximum: Ley 42-01 Art. 115 sets a 60-to-90-day limit for medicines and their registration only, and no statutory period for sanitary products was found.

The service entry is device-specific: its '¿A quién va dirigido?' is 'Empresas que se dedican a la comercialización de productos sanitarios' and its requirements list names '(Dispositivos médicos)' twice, for product plans/schematics and for product-family applications. It is the only device decision clock found in this market.

The clock is not split by product class anywhere, because there is no in-force class axis to split it by.

A related but medicines-only period is deliberately NOT recorded as a device clock: Ley 42-01 Art. 115 Párrafo IX bars the holder from marketing a product for the ninety days after a reference-laboratory-based registration, and Decreto 246-06 Art. 63 gives one month for alegaciones after a denial. Both are medicines provisions and neither is a device review clock.

The renewal service page publishes the same 90 días laborables as the registration page.

CONTRADICTION BETWEEN THE PUBLISHED FIGURE AND THE GOVERNING INSTRUMENT, disclosed rather than resolved: Decreto 117-18 as amended by Decreto 45-23 Art. 2 provides that 'La renovación de los registros sanitarios de los alimentos, medicamentos, productos sanitarios, cosméticos, higiene personal y del hogar será automática' once the renewal fee is paid and the registration to be renewed is in force, and Art. 3 provides that the automatic renewal 'se realizará a partir del depósito de la solicitud'. On the automatic-renewal reading there is no substantive review of a renewal dossier, so a 90-working-day decision clock cannot describe the ordinary case — the published 90 days describes the service counter's handling time, not a review.

The 90 días laborables stays correct for the residual case in which DIGEMAPS finds a discrepancy against an automatically renewed registration and the holder must submit a modification, which is why the row keeps its officialTimeline.

Renewal is automatic provided the renewal fee has been paid and the registration to be renewed is in force; the holder must file within the three months before expiry, and a registration that reaches expiry without an application is cancelled with no right to an extension (Decreto 117-18 as amended by Decreto 45-23, Artículos 2-4).

Where the registration has changed in any way, the modification application must be filed together with the renewal and both fees paid; if DIGEMAPS finds a discrepancy against an automatically renewed registration the holder must submit the modification procedure within 15 calendar days (Art. 2 Párrafo II), and a modification filed within the six months before expiry causes the certificate to issue with automatic renewal (Art. 5).