Dominican Republic medical device registration timeline
Source-linked clocksDirección General de Medicamentos, Alimentos y Productos Sanitarios (DIGEMAPS), Ministerio de Salud Pública y Asistencia Social (DIGEMAPS) review clocks and end-to-end planning ranges, using the No in-force device risk-class axis: the registration dossier requires the applicant to declare the product's 'nivel de riesgo' and the GMP certificate 'correspondiente a la clasificación del producto solicitado', but the class names (I, IIa, IIb, III) sit in a draft Reglamento Técnico de Productos Sanitarios y/o Dispositivos Médicos that is not in force. No timeline row therefore carries a riskLevel. classification system.
2 pathways2 of 2 clocks verifiedvalidity The authorisation is temporary and must be revalidated (Ley 42-01 Art. 116); in practice renewal is automatic on payment of the fee while the registration is in force, filed within the three months before expiry (Decreto 117-18 as amended by Decreto 45-23). No fixed term of years for sanitary products was evidenced.MDSAP not acceptedreviewed 2026-09-16digemaps.gob.do
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Sanitary registration — new registration (all sanitary products)(Registro Sanitario under Ley 42-01, Decreto 246-06 and Resolución 000020, filed on form DGDF-RP-FO-001 through the MSP Ventanilla Única de Servicios) '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. | 90 working days | 3-6 months | — | Verified |
| Sanitary registration — renewal (all sanitary products)(Renovación del Registro Sanitario, filed within the three months before expiry; automatic on payment of the fee while the registration is in force) The renewal service page publishes the same 90 días laborables as the registration page. | 90 working days | 1-3 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Dominican Republic Medical Device Registration Process
Step-by-step DIGEMAPS registration process. Total estimated timeline: 3-6 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by DIGEMAPS. Appoint a Establecimiento farmacéutico representante — a pharmaceutical establishment registered as representative in the Dominican Republic, holding its own current establishment sanitary registration.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to DIGEMAPS including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksDIGEMAPS reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
90 working daysIn-depth technical assessment of device safety and performance. DIGEMAPS may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, DIGEMAPS issues Dominican Republic market authorization certificate.
Summary: The Dominican Republic medical device registration process through Dirección General de Medicamentos, Alimentos y Productos Sanitarios (DIGEMAPS), Ministerio de Salud Pública y Asistencia Social (DIGEMAPS) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
Prior approval recognition
WHO Strict Authorities — US FDA, Health Canada, Japan NIHS, Australia TGA, EMA, Icelandic Medicines Agency, Norwegian Medicines Agency, Liechtenstein AMLEligibility for the simplified registration procedure under Resolución No. 000004 on a Certificate of Free Sale plus a good-manufacturing-practices certificate from that authority, for new registrations and renewals of imported products; the remaining legal requirements still apply and DIGEMAPS retains the decision.No published period: the MSP service listing shows 'Inmediatamente' rather than a number of days.
PAHO/PARF regional reference authorities (ARNr) — ANMAT, ANVISA, CECMED, INVIMA, COFEPRISSame simplified-procedure eligibility as the WHO Strict Authorities under Resolución No. 000004.No published period.
Japan PMDA and Korea MFDSNeither is named in the Resolución No. 000004 recognition list — Japan appears there only as NIHS — so a PMDA or MFDS marketing approval confers no simplified-procedure eligibility and the application is assessed under the ordinary route. DIGEMAPS' IMDRF affiliate membership creates no recognition route.
Key requirements
- The application must be filed by a pharmaceutical establishment established as representative in the Dominican Republic under a power of representation that is notarised and certified before the Procuraduría for national applicants, or legalised or apostilled for imported products, and that establishment must hold a current sanitary registration (DIGEMAPS registration requirements).
- An imported product requires a current original Certificate of Free Sale from the health authority of the country of origin and a current original good-manufacturing-practices or quality-system certificate of the manufacturing laboratory, both legalised or apostilled (DIGEMAPS registration requirements).
- The dossier must include the official technical sheet (DGDF-RP-FO-005) and the professional information sheet (DGDF-RP-FO-007), professional-use information stating uses, indications, warnings, precautions, contraindications and the product's risk level, and two original finished-product samples with at least one year of validity.
- The file must include the product description with main parts and specifications, plans or schematics for medical devices, technical studies and analytical checks with a summary of design tests and specifications, and an original certificate of analysis of the finished product matched to the deposited samples.
- Documents in a language other than Spanish must be translated by a judicial interpreter, and labels, inserts and packaging must be filed as actually marketed.
- Renewal must be filed within the three months before expiry; renewal is automatic on payment of the fee while the registration is in force, and the registration is cancelled with no right to an extension if it reaches expiry without an application (Decreto 117-18 as amended by Decreto 45-23).
- Advertising and promotion of sanitary products to the general public requires authorisation or notification from DIGEMAPS under the reglamento brought into force by Resolución 000033-15.
- Importers, manufacturers and health professionals must report adverse effects caused by sanitary products to DIGEMAPS whenever a danger to life or health may derive from them (Ley 42-01 Art. 116 Párrafo I).
Primary regulator sources
digemaps.gob.do · DIGEMAPS — Registro sanitario de productos sanitarios: tiempo de respuesta (90 días laborables) digemaps.gob.do · DIGEMAPS — Renovación de registro sanitario de productos sanitarios: tiempo de respuesta msp.gob.do · MSP — Procedimiento simplificado: costo del servicio y tiempo de respuesta (Inmediatamente / según los requisitos) burocraciacero.gob.do · Decreto núm. 45-23 que modifica el Decreto núm. 117-18 — renovación automática de registros sanitarios, Artículos 2, 3 y 4 digemaps.gob.do · Resolución No. 000004 del 27 de enero de 2016 — criterios para la aplicación del registro sanitario, venta libre y buenas prácticas de establecimientos
Reviewed 2026-09-16. End-to-end totals remain planning estimates.
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Source-linked review clocks verified against DIGEMAPS publications · full review 2026-09-16 · row IDs are stable — cite as registration-timeline:dominican-republic:sanitary-registration-new