Dominican Republic Device Registration: Titular, Representative and Co-Distributors

Short answer: In the Dominican Republic, a medical device needs a DIGEMAPS sanitary registration (registro sanitario) before it can be imported, distributed or used. A Dominican establishment licensed by DIGEMAPS must file the application under a power of attorney from the product owner, and that local establishment is the importer of record. DIGEMAPS’s device procedures distinguish the titular (the product owner) from the local representative, and they include published routes to add a co-distributor, change the representative, or change the titular. Your control over the registration depends on how those roles are set up at filing and on what your distribution agreement says.

This guide is for medical device manufacturers in the United States, Latin America and elsewhere who plan to sell in the Dominican Republic. It adds to our DIGEMAPS registration overview, which covers the dossier itself.

Key takeaways

• Registration is mandatory for medical devices. Being non-implantable does not exempt a device.
• The application is filed and endorsed by a DIGEMAPS-licensed Dominican establishment and its technical director, under a power of attorney from the product owner.
• Imports come in through the licensed local establishment named on the registration. In practice, the local registered party is the importer of record. A foreign manufacturer cannot import directly under the registration.
• DIGEMAPS publishes separate procedures for adding a co-distributor, changing the representative and changing the titular. Each one runs on a power of attorney from the titular.
• The device-specific regulation published as a draft in January 2025 is not in force. Today’s rules are Ley 42-01, Decreto 246-06 and DIGEMAPS’s published procedures.
• The distribution agreement is where you protect the registration. Dominican distributor-protection law limits how you can end the relationship, so have Dominican counsel draft those terms.

What rules apply today

Three layers are in force:

1. Ley General de Salud No. 42-01. The framework law for health products, including registration and imports.
2. Decreto 246-06, Reglamento de Medicamentos. It is written for medicines. It has no device chapter, but DIGEMAPS lists it as the legal basis for registering productos sanitarios. The articles that matter most here are Art. 23 and 25 (who may file), Art. 31 (power of attorney from a foreign owner), Art. 77 to 79 (changes to a registration) and Art. 104 (imports).
3. DIGEMAPS’s published service procedures for productos sanitarios. These list the documents for a new registration, a change of titular, a change of representative and the inclusion of a co-distributor.

Proposed, not in force: the Ministry of Public Health has published a draft Reglamento de Productos Sanitarios y/o Dispositivos Médicos, dated January 2025. It would add device classes (I, IIa, IIb and III, following the EU approach), family rules and holder rules. As of October 2026 we have not seen it enacted. Treat it as a signal of direction, not as a rule you can file against.

Who files the application

Decreto 246-06 limits who may file and hold registrations to licensed Dominican establishments, such as manufacturing laboratories and distributors (Art. 23). The application must be endorsed jointly by the titular of a licensed pharmaceutical establishment and that establishment’s technical director (Art. 25).

DIGEMAPS’s device registration page asks for:

• a current copy of the sanitary registration certificate of the applicant or representative establishment, laboratory or distributor
• a power of attorney from the product owner (empresa titular) in favor of the representative establishment in the Dominican Republic, notarized and apostilled or legalized for imported products
• a Certificate of Free Sale from the country of origin, and a manufacturing or quality-system certificate, both apostilled or legalized
• a ONAPI trademark certificate, where applicable

So a foreign manufacturer cannot file on its own. It needs a licensed local establishment.

Titular and representative: two roles

This is the point sponsors most often get wrong.

The medicines text in Decreto 246-06, Art. 31(c), says the power of attorney goes to the Dominican establishment that files the application, “que será el titular”, meaning that establishment becomes the holder.

DIGEMAPS’s device procedures use different language. They refer to the “empresa titular” (the product owner) granting a power of attorney to the “establecimiento farmacéutico representante” (the local representative). They also offer separate procedures to change the titular and to change the representative.

For devices, this means the foreign manufacturer may be able to appear on the registration as titular, with the licensed local company as representative and importer. How a given certificate names each party is something to confirm with DIGEMAPS before filing. Where the manufacturer can be named as titular, it is the stronger position, because later changes of representative run mainly on the titular’s own power of attorney.

Who imports

Imports go through a licensed Dominican establishment named on the registration:

• Decreto 246-06, Art. 104, allows imports only when both the product and the establishments involved hold a valid registration at the time of import. Only persons authorized by the health ministry may import (Art. 104, Párrafo II). The article is written for pharmaceutical products and is applied to devices through DIGEMAPS practice.
• Import permits are requested through the VUCE single window and are consigned to the product’s registered representative.

In practice, the local registered party is the importer of record. A foreign manufacturer cannot ship directly to hospitals or buyers under the registration, and neither can a foreign consultant.

Can more than one company import or distribute

Yes, with the titular’s authorization. DIGEMAPS publishes a procedure called Modificación / Inclusión de Co-distribuidor for productos sanitarios. It requires:

• the modification request form (DGDF-RP-FO-004)
• the current registration certificate of the requesting establishment
• a power of attorney from the product titular to the co-distributor
• the co-distributor’s own DIGEMAPS establishment registration
• the co-distributor’s drug and import permits, where they apply

So a registration is not locked to one commercial partner. More than one licensed Dominican company can be authorized under it, but only if the titular grants each one a power of attorney. Before relying on this, confirm with DIGEMAPS whether each co-distributor can clear imports of your device on its own permit.

Changing the representative or the titular later

DIGEMAPS publishes a separate procedure for each change.

Change of representative (Modificación de Representante):

• the modification request form (DGDF-RP-FO-004)
• the current registration certificate of the representative or distributor establishment
• a copy of the product registration certificate being modified
• a power of attorney from the registration titular to the new representative

Change of titular (Modificación de Titular):

• the modification request form (DGDF-RP-FO-004)
• the original current registration certificate
• drug and import permits, where they apply
• a power of attorney from the registration titular to the new representative
• documents authorizing the transfer
• a new manufacturing contract, if the titular is not the manufacturer
• for imported products, a power of attorney from the foreign titular to the establishment that will distribute in the Dominican Republic
• updated label art, insert and packaging, plus an updated technical sheet and professional information sheet

DIGEMAPS lists a response time of 90 working days for each procedure. That is a service target, not a guaranteed approval date.

Notice what the change of titular asks for: the original certificate and documents authorizing the transfer. If a distributor is the titular and will not cooperate, it can stall the change by holding back the original certificate or files. That is why the distribution agreement matters.

Structure options

What to put in the distribution agreement

These are the terms we suggest sponsors raise with their Dominican counsel. They reduce the risk that a distributor holds the registration hostage.

• Name the manufacturer as titular where DIGEMAPS allows it, with the distributor as representative only.
• State ownership. The distributor acts on the registration solely on the manufacturer’s behalf. The manufacturer owns the technical dossier, the data and the trademarks.
• Register trademarks with ONAPI first. Do this before appointing the distributor, and prohibit the distributor from filing any trademark of its own for your products.
• Limit the power of attorney to regulatory acts, for a fixed term that ends with the agreement, revocable by the manufacturer.
• Require cooperation on demand. Within a fixed number of days after the manufacturer asks, for any reason, the distributor signs every document DIGEMAPS needs for a change of representative or a transfer. It also returns the original certificate, DIGEMAPS correspondence, import records and dossier copies.
• Back it with a notarized special power of attorney. At signing, the distributor grants one to the manufacturer or to a Dominican law firm acting as escrow agent, so the documents can be signed if the distributor does not cooperate. Renew it periodically. This is generally more reliable than an undated letter signed in advance.
• Prohibit retention, liens or set-off over the registration. Also prohibit cancelling it or letting it lapse, and set deadlines for renewals and for reporting DIGEMAPS requests.
• Keep cooperation separate from money disputes, so a disagreement over compensation cannot hold up the transfer.
• Set out who pays transfer costs, with daily penalties for delay and a dispute resolution clause.

A note on Dominican distributor-protection law

The Dominican Republic has a law that protects local distributors and agents of foreign companies, Ley 173-66. In general terms, ending or not renewing a distribution relationship without just cause can lead to compensation claims, and those protections may not be waivable by contract. How it applies depends on your contract, your country of origin and the facts. Consult Dominican counsel before you sign, and have them draft the term, termination and just-cause provisions.

How the draft regulation could change this

If the January 2025 draft is enacted as published, it would:

• set device classes I, IIa, IIb and III. Under its Rule 6(e), short-term surgically invasive devices intended to diagnose, monitor or correct a defect of the heart or central circulatory system through direct contact would be Class III.
• limit who may file to local laboratories and distributors, as titulares or representatives (Art. 20)
• require a power of attorney from the foreign titular to the local applicant (Art. 28(f))
• add a procedure for assignment of rights (cesión de derechos, Art. 90)

None of this is in force yet. Today, DIGEMAPS asks the applicant to declare the device’s risk level in the dossier.

Where bioaccess® fits

bioaccess® prepares the DIGEMAPS dossier and files it together with your licensed local representative, answers DIGEMAPS questions through approval, and advises on the regulatory terms for your distribution agreement. bioaccess® does not act as registration holder, representative or importer of record in the Dominican Republic. That role belongs to a DIGEMAPS-licensed Dominican establishment.

To start, send us your IFUs, your SKU list (code, description, device type, sizes, sterilization method, manufacturing site) and your current certificates through our contact page.

Frequently asked questions

Does a non-implantable device need DIGEMAPS registration?

Yes. DIGEMAPS registration is required for the import, distribution and use of productos sanitarios in the Dominican Republic. Being non-implantable does not exempt a device.

Can a foreign manufacturer hold the registration itself?

It cannot file or import on its own. A licensed Dominican establishment must file and import. DIGEMAPS’s device procedures do distinguish the titular (product owner) from the local representative, so the manufacturer may be able to appear as titular. Confirm with DIGEMAPS how the certificate will name each party.

Who is the importer of record?

The licensed Dominican establishment named on the registration. Import permits are requested through VUCE and consigned to the product’s registered representative.

Can I have more than one distributor?

Yes. DIGEMAPS publishes a procedure to add a co-distributor to an existing registration. It needs a power of attorney from the titular to the co-distributor and the co-distributor’s own DIGEMAPS establishment registration.

How do I change distributors after registration?

File a change of representative, or a change of titular if the distributor is the titular. Both need a power of attorney from the titular. DIGEMAPS lists 90 working days for each. If the distributor is the titular, you will need its cooperation, which is why the distribution agreement should require it.

Is the January 2025 device regulation in force?

No. It is a draft published by the Ministry of Public Health. As of October 2026 we have not seen it enacted. Current rules are Ley 42-01, Decreto 246-06 and DIGEMAPS’s published procedures.

Can my distributor refuse to hand over the registration?

It can try to delay by holding back the original certificate or files. Name yourself as titular where DIGEMAPS allows it, and put cooperation-on-demand duties and an escrowed notarized power of attorney in the agreement. Dominican distributor-protection law can still affect termination, so consult Dominican counsel.

Does bioaccess® act as holder or importer in the Dominican Republic?

No. bioaccess® prepares and files the dossier with your licensed local representative and advises on the distribution agreement. A DIGEMAPS-licensed Dominican establishment acts as representative and importer.

Sources

• DIGEMAPS, Registro Sanitario de Productos Sanitarios (service page)
• DIGEMAPS, Modificación de Titular – Productos Sanitarios
• DIGEMAPS, Modificación de Representante – Productos Sanitarios
• DIGEMAPS, Modificación / Inclusión de Co-distribuidor – Productos Sanitarios
• Ley General de Salud No. 42-01
• Decreto 246-06, Reglamento de Medicamentos (Art. 23, 25, 31, 77–79, 104)
• Ministerio de Salud Pública, draft Reglamento de Productos Sanitarios y/o Dispositivos Médicos (January 2025, not in force)

General information, not legal advice. DIGEMAPS requirements change; confirm the current procedure and have Dominican counsel review your distribution agreement.