Dominican Republic clinical trial regulatory guide

Regulator: CECMED (Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos)

The Dominican Republic is developing its clinical research infrastructure with DIGEMAPS (historically referenced as CECMED) overseeing medical device registration and clinical trials. The country follows a risk-based classification system (I, IIa, IIb, III) with a 240-working-day approval timeline for device registration. A local Authorized Representative is mandatory for foreign manufacturers.

Approval process

1. Ethics Committee Approval. Submit to CONABIOS-registered ethics committee.
2. DIGEMAPS Authorization. Submit clinical trial application to the regulatory authority.
3. Import Authorization. Obtain import permit for investigational devices.
4. Site Activation. Finalize site agreements and begin enrollment.

Ethics requirements

• CONABIOS-registered ethics committee review required
• Informed consent in Spanish
• Participant insurance mandatory
• Continuing review required

Documentation requirements

• Clinical trial protocol in Spanish
• Investigator brochure
• Device technical dossier including IEC 62304 for SaMD
• GMP/ISO 13485 certificates
• Insurance documentation
• Notarized, apostilled, and certified Spanish-translated legal documents

Device registration

DIGEMAPS governs medical device registration following a risk-based classification (I, IIa, IIb, III). The approval timeline is a study-specific timeline (we confirm it per protocol). SaMD products must include IEC 62304 compliance and cybersecurity documentation. A renewable sanitary registration is required.

FDA acceptance of Dominican Republic data

FDA accepts Dominican Republic clinical data under 21 CFR 812.28 when studies follow ICH-GCP. The country's growing research capacity and alignment with international standards make it a developing option for generating FDA-submissible data.

Key contacts

• DIGEMAPS — General Directorate of Medicines and Health Products
• CONABIOS — National Bioethics Council

Frequently asked questions

What is the device registration timeline in Dominican Republic?

Varies by study; we confirm per protocol for a complete registration.

Is a local representative required?

Yes, a local Authorized Representative (AR) is mandatory for all foreign manufacturers.

Does the DR cover SaMD?

Yes, SaMD requires mandatory approval including IEC 62304 compliance and cybersecurity reports.

How long is the sanitary registration valid?

Sanitary registrations are renewable; we confirm the current validity period with DIGEMAPS for each product.

Can DR data support FDA submissions?

Yes, when studies follow ICH-GCP and ISO 14155 standards.

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