DIGEMAPS · Americas

Dominican Republic medical device regulatory resources

Every Dominican Republic dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

4 free resources22/25 topics with records2 regulations trackedSep 2026 fees reviewed

Open the medical device hub

Everything we track for Dominican Republic

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Dominican Republic requirements.

Government registration fees

Review current DIGEMAPS application, review, and renewal fees.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Medical device regulations

Browse the Dominican Republic's official medical-device instruments — the General Health Law and the decree amending the renewal regulation — with citeable Spanish passages.

Structured regulatory requirements

Explore all 32 source-linked facts →

22 of 25 research dimensions currently covered · 19 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified

DIGEMAPS is the competent authority for medical devices, created by Decreto 82-15 under the Ministry of Public Health: statement: The Dirección General de Medicamentos, Alimentos y Productos Sanitarios (DIGEMAPS) is the regulatory authority for medicines, food and sanitary products (including medical device…

1 source-linked fact

Checked 2026-09-16

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D02

Legal basis & guidance

Verified

Instruments governing registration of medical devices: statement: The registration of sanitary products rests on the Ley General de Salud (Ley 42 01) and on Decreto 246 06 (Reglamento de Medicamentos) as amended, together with Resolución 000020…

1 source-linked fact

Checked 2026-09-16

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D03

Device definition & scope

Verified

Product categories the health law subjects to sanitary control: statement: Article 109 of the Ley General de Salud assigns the Ministry of Public Health, through the institutions created for the purpose, sanitary control of medical equipment, prostheses…

1 source-linked fact

Checked 2026-09-16

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D04

Classification rules

Unresolved

Being 'classified as low risk by DIGEMAPS' is one of three gateways to the simplified registration procedure (Res. 000004-16, SEGUNDO num. 3): Resolución 000004 16 lists three alternative criteria for a new registration or renewal to use the simplified procedure: (1) imported products previously authorised by a WHO stringent autho…

1 source-linked fact

Checked 2026-09-16

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D05

Registration pathways

Verified

Sanitary registration is mandatory before import, distribution or use: statement: Obtaining a sanitary registration (registro sanitario) is obligatory for the manufacture, production, import, packaging, storage, transport, promotion, distribution and use of sa…
Transactions eligible for the simplified procedure: statement: The simplified procedure is available for new registrations and renewals of existing registrations, and also for modifications to a manufacturer's installations, substantial chan…

2 source-linked facts

Checked 2026-09-16

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D06

Reliance & recognition

Verified

Origin-country free-sale certificate and manufacturer GMP certificate required in the dossier: statement: For an imported device, the sanitary registration dossier must include a current original certificate of free sale for the product issued by the health authority of the country o…
Simplified registration for imported products previously authorised by a WHO Strict Authority or a PAHO/PARF regional reference authority: statement: An imported product that has previously been authorised by a WHO Strict Authority or by a regional reference regulatory authority (ARNr) of the PAHO/PARF network may be registere…

2 source-linked facts

Checked 2026-09-16

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D07

Economic-operator roles

Verified

A locally registered pharmaceutical establishment must act as representative: statement: The foreign title holder must grant a power of representation to a pharmaceutical establishment established as representative in the Dominican Republic, duly notarised and certif…

1 source-linked fact

Checked 2026-09-16

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D08

Establishment, import & distribution

Verified

Distributors must be habilitated and run by a licensed pharmaceutical technical director: statement: Opening, relocating or renewing a distributor requires an evaluation and inspection by DIGEMAPS' Dirección de Vigilancia Sanitaria leading to a habilitation certificate; the file…

1 source-linked fact

Checked 2026-09-16

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D09

Dossier requirements

Verified

Contents of the registration dossier for an imported medical device: statement: The dossier for an imported sanitary product comprises: the registration application form; the representative establishment's current registration certificate; the notarised/apos…

1 source-linked fact

Checked 2026-09-16

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D10

Official forms & portals

Verified

Official registration forms and the online services portal: statement: DIGEMAPS registration transactions use numbered official forms: DGDF RP FO 001 for the registration application, DGDF RP FO 004 for a modification, DGDF RP FO 005 for the officia…

1 source-linked fact

Checked 2026-09-16

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Submission & evidence

D11

Label, IFU & language

Verified

Documents in a language other than Spanish must be translated by a judicial interpreter: statement: Ley 42 01 Art. 112 requires the legends and texts of the labels of the products covered by Libro Cuarto (which includes the Art. 109(b) device families) to be written in Spanish,…

1 source-linked fact

Checked 2026-09-16

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D12

QMS, audit & inspection

Verified

GMP evidence and inspection of manufacturing laboratories: statement: Registration and renewal of a sanitary product require a current good manufacturing practices certificate, or a quality system certification corresponding to the product's classi…

1 source-linked fact

Checked 2026-09-16

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D13

Standards, testing & ancillary approvals

Unresolved

Medical electrical safety and EMC evidence inside the sanitary registration: Electrical safety
CNE import permit for radioactive sources and ionizing-radiation-emitting devices: Radiation
CNE institutional operating licence and radiological protection officer licence: Radiation

4 maintained overlays · 1 related fact

Checked 2026-09-16

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D14

Fees

Verified

Registro Sanitario de Productos Sanitarios — procedimiento simplificado, nuevo registro: DOP 18,000
Registro Sanitario de Productos Sanitarios — procedimiento simplificado, renovación: DOP 18,000

3 maintained fee lines · 1 related fact

Checked 2026-09-16

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D15

Review clocks

Unresolved

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: 90 working days
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: 90 working days

2 maintained pathways · 4 related facts

Checked 2026-09-16

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D16

Approval validity & renewal

Verified

Sanitary authorisation is temporary and must be revalidated: statement: Under the Ley General de Salud the authorisation for medicines and other sanitary products is temporary; once its term expires it must be revalidated in the form and within the p…
Renewal is automatic on payment while the registration is in force; applications lodge in the last three months: statement: Renewal of the sanitary registration of foods, medicines, sanitary products, cosmetics and hygiene products is automatic provided the renewal service fee has been paid and the re…

2 source-linked facts

Checked 2026-09-16

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Lifecycle & post-market

D17

Change control

Verified

Modifications are filed with the renewal; a modification in the last six months renews the registration: statement: Where the registration has undergone changes of any nature the holder must file the modification application at the same time as the renewal and pay the fees for that transaction…

1 source-linked fact

Checked 2026-09-16

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D18

UDI, listing & traceability

Verified

Lot-level traceability records for imported and distributed products: statement: Decreto 246 06 obliges the technical director of an importing establishment to establish traceability records of the products brought in and to record which establishments they a…

1 source-linked fact

Checked 2026-09-16

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D19

Clinical investigation & performance

Verified

Prior CONABIOS approval and supervision of clinical and biomedical research: statement: Every clinical and biomedical investigation carried out in Dominican territory must obtain CONABIOS's prior approval and be supervised by it, the protocol having to respect the l…

1 source-linked fact

Checked 2026-09-16

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D20

Special access & derogation

Verified

Emergency dispensation from the sanitary-control regulations: statement: Dominican law empowers the health authority, in situations of emergency resulting from a disaster of any origin, to dispense temporarily with the application of the sanitary cont…

1 source-linked fact

Checked 2026-09-16

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D21

Manufacturer PMS

Verified

Holder's adverse-effect reporting duty and renewal pharmacovigilance filing: statement: Sanitary authorisations for medicines and other sanitary products are temporary: the holder must notify its intention to keep the products on the market so the authorisation does…

1 source-linked fact

Checked 2026-09-16

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D22

Vigilance & incident reporting

Verified

Importers, manufacturers and health professionals must report adverse effects: statement: Under the Ley General de Salud, importers, manufacturers and health professionals are obliged to communicate the adverse effects caused by medicines and other sanitary products w…

1 source-linked fact

Checked 2026-09-16

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D23

Recall, FSCA & market surveillance

Verified

DIGEMAPS publishes safety alerts and market withdrawals: statement: DIGEMAPS maintains a public 'Alerta Sanitaria de Seguridad' register through which it publishes numbered sanitary alerts and market withdrawals (alerts numbered FVA YYYY NNNN) co…

1 source-linked fact

Checked 2026-09-16

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D24

Advertising, claims & promotion

Verified

Advertising of sanitary products requires prior authorisation and is regulated by Resolución 000033-15: statement: Advertising and promotion of medicines, cosmetics, sanitary products and personal and household hygiene products in written, radio, television and social media channels addressed…

1 source-linked fact

Checked 2026-09-16

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D25

Submission communications & appeal

Verified

Administrative reconsideration and hierarchical review against a decision: statement: Administrative acts that end a procedure, prevent its continuation, produce defenselessness, harm subjective rights or cause irreparable damage may be challenged directly by the…
Completeness check, deficiency notice and re-entry of a sanitary registration application: statement: A sanitary registration application for a sanitary product is prepared from DIGEMAPS's published requirements list and filed online or in person at the Dirección de Gestión de Se…

2 source-linked facts

Checked 2026-09-16

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Government fees

Full fee schedule (3 lines) →

DIGEMAPS registration fees in DOP · reviewed 2026-09-16

Fee line	Amount	Provenance
Registro Sanitario de Productos Sanitarios — procedimiento simplificado, nuevo registro	DOP 18,000	Verified
Registro Sanitario de Productos Sanitarios — procedimiento simplificado, renovación	DOP 18,000	Verified
Autorización de publicidad y promoción (productos sanitarios)	DOP 1,000	Verified

Registration timeline

Full registration timeline →

Dirección General de Medicamentos, Alimentos y Productos Sanitarios (DIGEMAPS), Ministerio de Salud Pública y Asistencia Social (DIGEMAPS) review clocks and planning ranges · 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

Class / pathway	Review clock	Planning total	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)	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)	90 working days	1-3 months	Verified

1Pre-Submission Preparation(1-3 months)
2Application Submission(1-2 weeks)
3Administrative Review(2-4 weeks)
4Technical Evaluation(90 working days)
5Registration Approval(1-2 weeks)

Key regulations

All 2 Dominican Republic regulations →

Official DIGEMAPS rules and guidance · 2 of 2 documents linked to official sources

Decreto núm. 45-23Decreto núm. 45-23 que introduce modificaciones al Decreto núm. 117-18, Reglamento para la Renovación Automática de los Registros Sanitarios de los Alimentos, Medicamentos, Productos Sanitarios, Cosméticos y de Higiene

RegistrationVerified

Ley No. 42-01Ley General de Salud de la República Dominicana

GeneralVerified

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