DIGEMAPS

What DIGEMAPS does

DIGEMAPS (Dirección General de Medicamentos, Alimentos y Productos Sanitarios) is the Dominican Republic's national regulatory authority for medications, food, beverages, cosmetics, sanitary products, and medical devices. Operating as a decentralized agency under the Ministry of Public Health and Social Assistance (MISPAS), DIGEMAPS holds exclusive statutory authority over sanitary registrations, pre- and post-market surveillance, manufacturing facility inspections, import/export control, and enforcement actions including seizures and product destructions. The agency serves domestic and international manufacturers, distributors, and importers seeking market authorization in the Dominican Republic, and protects the general public through pharmacovigilance, sanitary alerts, and recalls.

DIGEMAPS operates a portfolio of core regulatory services including sanitary registration of medicines, cosmetics, sanitary products, and pre-packaged foods/beverages; sanitary surveillance; controlled substances regulation; and the Cuadro Básico de Medicamentos Esenciales (national essential medicines list of 871 medications and 506 active principles). Supporting infrastructure includes the Laboratorio de Evaluación de Productos de Consumo Humano (LEPCH) for product testing and the Portal de Autoservicios for online submission of registration applications. The agency maintains a Citizen Satisfaction Index of 91% (2022) following modernization reforms under Burocracia Cero and Decree 284-21, which reduced average sanitary registration timelines from approximately 370 days to under 70 days, with some categories achievable in 24 hours via Decree 58-23 homologation.

The business model is non-commercial: DIGEMAPS is funded through the Dominican government budget and does not sell products or generate disclosed revenue. Pricing for sanitary registrations, inspections, and renewals is not publicly disclosed. Strategic value derives from regulatory monopoly, international credentials (IMDRF affiliate membership, ICH and IPRP participation, US FSIS meat inspection equivalence), and integration into regional networks including SICA/COMISCA and REDCAM. With 251–500 employees and operational throughput of over 18,000 active sanitary registrations and tens of millions of illegal units interdicted annually, DIGEMAPS functions as a sovereign regulatory institution rather than a market-investable entity.

Name

DIGEMAPS

Legal name

Dirección General de Medicamentos, Alimentos y Productos Sanitarios (DIGEMAPS)

Website

https://digemaps.gob.do

Company type

Private

Founded year

1998

Operating status

Operating

Headcount range

251–500 employees

Short description

DIGEMAPS is the Dominican Republic's national regulatory authority for medicines, food, beverages, cosmetics, sanitary products, and medical devices. Operating under the Ministry of Public Health, it issues sanitary registrations, conducts inspections and market surveillance, and manages the LEPCH testing laboratory and essential medicines list.

Ownership category

akta.pro rank

Product category

Pharmaceutical and Food Regulatory Services

SIC

Sanitary Services (4950)

akta.pro primary industry

Controlled Substances & Pharmacy Regulation Authorities (HLAJACAI)

akta.pro secondary industries

Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH), Sanitation & Hygienic Design Compliance (SSOPs, GMPs) (AFALADAJ), Sanitation, GMP & Prerequisite Program (PRP) Audits (SSOPs, Hygiene, Pest Control) (AFALABAI), Recall Readiness, Crisis Management & Regulatory Liaison (AFALADAG)

Keywords

• Pharmaceutical regulation
• Food safety oversight
• Sanitary registration services
• Medical device regulation
• Product market surveillance

Headquarters

HQ city

Santo Domingo

HQ country

Dominican Republic

HQ region

Latin America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Others

Distribution channels3 records

Marketing channels6 records

Core offering

DIGEMAPS is the Dominican Republic's national regulatory authority that issues sanitary registrations for medications, cosmetics, personal/home hygiene products, sanitary products (including medical devices), and pre-packaged food and beverages. It performs pre- and post-market sanitary surveillance, regulates controlled substances, conducts inspections of manufacturing facilities and import/export points, operates the LEPCH laboratory for product testing, manages pharmacovigilance and adverse event reporting, and issues sanitary alerts and product recalls to protect public health.

Product overview

DIGEMAPS (Dirección General de Medicamentos, Alimentos y Productos Sanitarios) is a Dominican Republic government regulatory agency that provides a portfolio of sanitary registration services for medications, cosmetics, personal/home hygiene products, sanitary products, and pre-packaged foods/beverages. The agency also operates sanitary surveillance, controlled substances regulation, and maintains the national essential medicines list (Cuadro Básico de Medicamentos Esenciales). A key supporting service is the Laboratory of Evaluation of Consumer Products (LEPCH) which performs product testing. Digital services include an online self-service portal for registration applications. The organization functions as a regulatory body rather than a product manufacturer, with its services focused on public health protection through regulatory oversight, market surveillance, and quality assurance of products entering the Dominican market.

Differentiator

Problem solved

Functional benefit

Products and services

• Registro Sanitario de Medicamentos (Sanitary Registration of Medicines) Sanitary registration service for pharmaceutical products that enables companies to obtain authorization to commercialize medications in the Dominican Republic, with average processing time reduced to 14 working days under the Burocracia Cero program.
• Registro Sanitario de Cosméticos, Higiene Personal y del Hogar (Sanitary Registration of Cosmetics and Personal/Home Hygiene Products) Sanitary registration service for cosmetics, personal hygiene products, and household products, enabling market authorization in the Dominican Republic.
• Registro Sanitario de Productos Sanitarios (Sanitary Registration of Medical Devices and Sanitary Products) Sanitary registration service for sanitary products including medical devices, aligned with IMDRF risk-based classification guidelines following DIGEMAPS's 2024 affiliate membership.
• Registro Sanitario de Alimentos y Bebidas Pre-Envasadas (Sanitary Registration of Pre-Packaged Foods and Beverages) Sanitary registration service for pre-packaged foods and beverages, enabling compliance with food safety requirements and supporting equivalence certification for export markets including the United States.
• Vigilancia Sanitaria (Sanitary Surveillance) Post-market sanitary surveillance service that monitors registered products for safety, issues alerts and market withdrawals, manages pharmacovigilance reporting, and conducts inspections of commercial establishments.
• Productos Controlados (Controlled Substances Regulation) Regulatory service for controlled substances including narcotics, controlled-substance medications, and chemical precursors, coordinated with DNCD under a 2025 inter-institutional cooperation agreement covering joint operations, information exchange, and use of the LEPCH laboratory.
• Cuadro Básico de Medicamentos Esenciales (National Essential Medicines List) National essential medicines list maintained by DIGEMAPS providing coverage of 871 medications and 506 active principles, supporting public health access and pharmaceutical policy decisions.
• Laboratorio de Evaluación de Productos de Consumo Humano (LEPCH) Government-operated analytical laboratory for evaluating and testing consumer products including food, medications, cosmetics, and sanitary products, used for regulatory compliance verification, colorimetric analysis of controlled substances (with UNODC kits), and joint enforcement operations.
• Portal de Autoservicios (Self-Service Portal) Online self-service portal for submitting sanitary registration applications, renewals, and tracking application status, enabling digital processing of regulatory submissions under the Burocracia Cero program.

Quantifiable outcome

• Reduced average sanitary registration timeline from ~370 days to under 70 days for several product categories; some via Decree 58-23 homologation now achievable in 24 hours
• +3 more outcomes

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

18 partnerships are on record, tiered core, moderate and minor.

• SICA/COMISCA (Sistema de la Integración Centroamericana / Consejo de Ministros de Salud de Centroamérica y República Dominicana)coreStrategic or Co-development Partner · 1 June 2026DIGEMAPS, as representative of the Dominican Republic, holds the Pro Tempore Presidency of COMISCA (January–June 2026), coordinating regional efforts on pharmaceutical regulation. The agency participates in the REDCAM (Central American Network of Medicines Regulatory Authorities) to promote regional regulatory coordination, joint evaluation of biotechnological medicines and biosimilars, and advancement toward the Central American Regulatory Agency (ACRS). DIGEMAPS Director Marcos Balaguer Jerez is a key voice in these regional integration efforts.
• AECID (Agencia Española de Cooperación Internacional para el Desarrollo)coreStrategic or Co-development Partner · 1 June 2026AECID supports the regional regulatory harmonization agenda through the Fondo España-SICA program, providing technical cooperation, expertise exchange, and funding for training programs on biotechnological medicines and biosimilars evaluation in Central America and the Dominican Republic. AECID participates in regional workshops alongside COMISCA and REDCAM.
• ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)coreStrategic or Co-development Partner · 1 November 2025DIGEMAPS achieved membership in the ICH, representing a major milestone in international regulatory convergence. ICH membership enables adoption of international guidelines that improve pharmaceutical quality and safety, strengthens regulatory decision-making using global scientific standards, and facilitates access to innovative, safe, and effective products for the Dominican population.
• IPRP (International Pharmaceutical Regulators Programme)coreStrategic or Co-development Partner · 1 November 2025DIGEMAPS joined the IPRP, enabling cooperation, scientific exchange, and best practice sharing with international pharmaceutical regulators. IPRP membership contributes to developing greater capacity for evaluating complex products including biotechnological and high-risk medical devices.
• DNCD (Dirección Nacional de Control de Drogas)coreStrategic or Co-development Partner · 4 September 2025DIGEMAPS and DNCD signed a two-year inter-institutional cooperation agreement to strengthen regulation, diversion control, inspection, and monitoring of narcotics, controlled-substance medications, and chemical precursors. The agreement includes joint operations, information exchange, shared use of the LEPCH laboratory, cross-training, and support for destruction of seized products. DNCD also provided UNODC colorimetric analysis kits for detecting controlled substances and chemical precursors.
• IMDRF (International Medical Devices Regulators Forum)coreStrategic or Co-development Partner · 8 October 2024DIGEMAPS achieved affiliate membership in the IMDRF, the leading international forum for medical device regulatory convergence. Membership involved adoption of risk-based medical device classification, strengthened post-market surveillance, and conformity assessment procedures aligned with IMDRF guidelines. This is significant given Dominican medical device exports of US$2,490 million in 2023 from 40 free trade zone companies employing 32,358 workers.
• Universidad ISAcoreStrategic or Co-development Partner · 17 September 2024Universidad ISA, with support from the US Department of Agriculture (USDA) through its Project Trade Safe (TraSa), developed and delivers the first meat inspection diploma program in the Dominican Republic, aimed at veterinarians, technicians, and inspectors of DIGEMAPS and partner institutions. The diploma covers five modules including inspection methods, processing, labeling, import/export, and public health veterinary practice.
• USDA / USDA Project Trade Safe (TraSa)coreStrategic or Co-development Partner · 17 September 2024The United States Department of Agriculture, through its Project Trade Safe (TraSa), provides technical and financial support to strengthen Dominican meat inspection capabilities. USDA has invested approximately $25 million through the PROGANA project to support equivalence achievement with US FSIS standards, enabling Dominican beef exports to the United States. TraSa continues to support capacity building including the meat inspection diploma program at Universidad ISA.
• MAP (Ministerio de Administración Pública)moderateStrategic or Co-development Partner · 17 September 2024The Ministry of Public Administration (MAP) led the institutional transformation methodology for DIGEMAPS, coordinating the '100-Day Challenge' innovation process alongside DIGEMAPS staff. MAP facilitated participation of entities including the National Competitiveness Council (CNC), OGTIC, and private sector associations to streamline sanitary registration processes under the Burocracia Cero and Decree 284-21 framework.
• Fedefarma (Federación Centroamericana y del Caribe de Laboratorios Farmacéuticos)coreStrategic or Co-development Partner · 26 August 2024Fedefarma serves as a strategic technical partner supporting DIGEMAPS's capacity building in biotherapeutic and biosimilar drug evaluation. Fedefarma co-developed a 7-week scientific-educational training program on biotherapeutic medicines, with evaluations and academic validation by INTEC and the University of Panama. This collaboration aims to accelerate registration of innovative therapies benefiting the Dominican population.
• INTEC (Instituto Tecnológico de Santo Domingo)moderateStrategic or Co-development Partner · 12 October 2022INTEC partnered with DIGEMAPS in the '100-Day Challenge' transformation methodology, providing academic support and facilitation through Re-Institute. INTEC also provides academic validation for the biotherapeutic medicines training program co-developed with Fedefarma. INTEC's participation was part of a World Bank-funded technical assistance initiative.
• Banco Mundial (World Bank)moderateStrategic or Co-development Partner · 12 October 2022The World Bank provided technical assistance financing for DIGEMAPS's institutional transformation and modernization under the Burocracia Cero program. The Bank supported the '100-Day Challenge' methodology and facilitated the engagement of Re-Institute for process innovation and simplification of sanitary registration procedures.
• MICM (Ministerio de Industria, Comercio y Mipymes)coreStrategic or Co-development PartnerMICM coordinates the Mesa de Ilícito (Anti-Illicit Trade Committee) and works with DIGEMAPS and CECCOM on joint enforcement operations to combat illegal medicines, counterfeit products, and contraband. DIGEMAPS provides technical regulatory support in these joint operations across multiple provinces.
• CECCOM (Cuerpo Especializado de Control de Combustibles y Comercio de Mercancías)coreStrategic or Co-development PartnerCECCOM is the operational enforcement arm of MICM in the fight against illegal trade. It conducts joint raids and seizures with DIGEMAPS at ports, airports, borders, pharmacies, and warehouses across Dominican provinces, leading to major confiscations of illegal medicines, cigarettes, and adulterated alcohol.
• FSIS/USDA (Food Safety and Inspection Service / United States Department of Agriculture)coreStrategic or Co-development PartnerFSIS/USDA conducted successful equivalence audits of Dominican Republic's meat inspection system, confirming DIGEMAPS's continued eligibility to export beef to the United States. The audit evaluated six equivalence components: government supervision, government verification, sanitation, HACCP, chemical residues, and microbiological testing programs. No findings or observations were identified.
• REDCAM (Red Centroamericana de Autoridades Reguladoras de Medicamentos y Tecnologías Sanitarias)coreStrategic or Co-development PartnerREDCAM is the Central American network of medicines regulatory authorities where DIGEMAPS actively participates to define joint evaluation mechanisms for biotechnological medicines and biosimilars. DIGEMAPS presented Dominican REDCAM priorities for 2026 PPT and led analysis of the legal framework for the future Central American Regulatory Agency (ACRS).
• AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)moderateStrategic or Co-development PartnerAEMPS provides expert accompaniment in practical exercises aimed at strengthening regulatory harmonization and regional technical cooperation, as part of the SICA/COMISCA workshops on biotechnological medicines and biosimilars evaluation.
• Government of El SalvadorminorStrategic or Co-development PartnerA delegation from the Government of El Salvador audited Dominican food safety and control systems, finding no issues that compromise product safety or system integrity, validating the effectiveness of DIGEMAPS's inspection framework.

Scale indicators8 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios): Mexico's national regulatory authority for medicines, food, cosmetics, medical devices, and sanitary products under the Ministry of Health. Directly comparable to DIGEMAPS in scope of regulated categories, registration functions, and federal structure, but operating at significantly larger scale.
• INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos): Colombia's national regulatory authority for medicines, food, cosmetics, and medical devices. Comparable in scope of regulated categories, registration processes, and post-market surveillance functions, serving a mid-sized Latin American market.
• ANVISA (Agência Nacional de Vigilância Sanitária): Brazil's national health surveillance agency regulating medicines, food, cosmetics, sanitizing products, and medical devices. Closely comparable in mandate and structure, though serving a far larger jurisdiction and recognized as a stringent regulatory authority of reference.
• ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria): Ecuador's national regulatory agency for health products, food, cosmetics, and medical devices. Comparable in mandate covering medicines, food safety, and sanitary registrations, serving a similar-sized Latin American market.
• DIGEMID (Dirección General de Medicamentos, Insumos y Drogas): Peru's national regulatory authority for pharmaceutical products, medical devices, and sanitary products under the Ministry of Health. Highly comparable in name, scope, and operating model to DIGEMAPS, both regulating medicines and health technologies in mid-sized Latin American economies.
• ISPCH (Instituto de Salud Pública de Chile): Chile's public health institute responsible for regulation of medicines, food, cosmetics, and medical devices. Comparable in laboratory testing, sanitary registration, and pharmacovigilance functions, and recognized as a reference regulator in the region.

Broad incumbents

• EMA (European Medicines Agency): European Union regulator for human and veterinary medicines. Comparable as a benchmark regulatory authority whose decisions can serve as references for DIGEMAPS through recognition mechanisms and ICH-aligned guidelines.
• FDA (U.S. Food and Drug Administration): United States federal regulator for medicines, food, cosmetics, and medical devices. As the leading stringent regulatory authority, FDA decisions underpin DIGEMAPS's reliance pathways and FSIS equivalence framework.
• AEMPS (Agencia Española de Medicamentos y Productos Sanitarios): Spain's national medicines and sanitary products regulator and a recognized stringent regulatory authority. Already a technical cooperation partner of DIGEMAPS through SICA/COMISCA workshops, and functions as a reference body whose decisions DIGEMAPS can leverage.

Regional players

• CECMED (Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos): Cuba's regulatory authority for medicines and medical devices. Comparable in mandate and Caribbean geographic context, though operating under a different health system model and not a direct competitor for registrations in the Dominican Republic.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/digemaps
• YouTubeyoutube.com/@Digemaps
• Facebookfacebook.com/share/19trTFRjVw/?mibextid=wwXIfr
• Instagraminstagram.com/digemaps?igsh=NHUwc21nZ3Fxc3Jl&utm_source=qr
• LinkedInlinkedin.com/company/digemaps

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about DIGEMAPS