How to register a medical device in the Dominican Republic with DIGEMAPS

Sponsors still write “Dominican Republic registration” as if DIGEMAPS were a customs stamp you buy after you pick a local reseller. It is not. DIGEMAPS names a single local Authorized Representative on each sanitary certificate. That party is the commercial face of the device for import, distribution, and post-market work under the Dominican rules — and if the distributor funds the filing, they usually own the number.

I am Julio Martinez-Clark, CEO of bioaccess®. This page is the commercial Dominican Republic file: how a medical device gets onto the market under DIGEMAPS (Dirección General de Medicamentos, Alimentos y Productos Sanitarios), what Decreto 82-15 and Decreto 246-06 actually do, and why the Authorized Representative seat is the decision you make before you sign an exclusive LOI. It sits next to our LATAM market-access hub, the DIGEMAPS country page, and the Importer of Record guide. Operator guidance only. Not a quote and not legal advice.

One-sentence answer

Commercial sale in the Dominican Republic requires DIGEMAPS sanitary registration with a single local Authorized Representative named on the certificate under the framework created by Decreto 82-15 (6 April 2015) and the substantive registration, import, distribution, and post-market rules in Decreto 246-06 — foreign manufacturers do not hold the number themselves, and transferring the local Authorized Representative role to a different Dominican entity needs DIGEMAPS approval.

Two Dominican desks — do not merge them

Investigational use. Ethics and clinical-research authorization for first-in-human or other device studies in the Dominican Republic. That file is not a license to sell. Keep trial import and commercial freight on separate accountability logs.

Commercial path. Manufacture, import, commercialization, or distribution of a device configuration you intend to sell. DIGEMAPS is the sanitary authority for that track. The certificate names one local Authorized Representative. Downstream sales partners can exist commercially; at the regulatory level there is one accountable local face per registration.

If your Gantt has one bar labeled “DIGEMAPS,” check whether you are asking for a trial petition or a selling license. Those are two work packages.

What Decreto 82-15 and Decreto 246-06 actually do

Decreto 82-15 created DIGEMAPS by merging the prior Drugs/Pharmacies and Food Risk Control directorates. It is the institutional home of the device sanitary file today — not a synonym for “MISPAS paperwork” generically.

Decreto 246-06 is the substantive rule set operators plan against for registration, import, distribution, and post-market duties. Do not invent a second Dominican statute number for a board slide. Plan against those instruments and current DIGEMAPS practice, and confirm forms before translators start.

Our live Importer of Record map treats the Dominican Republic as a single-Authorized-Representative market: one local AR per registration. Transferring that seat is not a private vendor swap. DIGEMAPS approval adds friction when you reshuffle commercial partners after launch.

What belongs in the commercial dossier (operator list)

Exact DIGEMAPS forms move with current practice. The working stack sponsors assemble before Spanish production starts is stable:

• Device identity, intended use, and Dominican risk class as DIGEMAPS will see it (commonly discussed as Class I / IIa / IIb / III — classify in the Dominican rule set; do not paste a US Class II memo)
• Manufacturer and manufacturing sites, with quality-system evidence appropriate to class
• Technical evidence already used for FDA or CE, mapped to the DIGEMAPS petition — not dumped as a zip of US folders
• Labels and IFU in Spanish for the configuration you will sell
• Local Authorized Representative appointment and Dominican entity documentation
• Import story that matches the named AR / importing face on the certificate — not a freight forwarder with a borrowed tax ID
• Tecnovigilancia ownership under the holder of the sanitary file

Operators also treat local trademark readiness (ONAPI) as a pre-file gate on many Dominican device petitions. Confirm the live DIGEMAPS checklist for your SKU before you pretend the sanitary clock has started. Electrical/EMC or RF homologation for wireless devices, when required, runs through the Dominican telecom authority as a separate vendor track. Do not bury that inside the DIGEMAPS sanitary clock.

What this file is not

• It is not a clinical-trial authorization. Trial units and commercial units follow different petitions.
• It is not “the distributor will handle registration.” In a single-AR market, whoever pays for and holds the certificate controls market access until DIGEMAPS approves a transfer.
• It is not an FDA or CE equivalence stamp. Prior clearances help the technical story; they do not replace DIGEMAPS registro for a commercial SKU.

How bioaccess® runs the Dominican seat

On the live market-access offer, bioaccess® sells DIGEMAPS registration processing funded by the manufacturer — dossier, translations, agency liaison, and hostage-proof contracting language for the distribution agreement — while the Dominican Authorized Representative / importer face sits on a structure that can transfer on demand. The Dominican Republic is not packaged as the standard annual LATAM Launch holder subscription on the country page; timelines are confirmed at proposal against the current DIGEMAPS queue. We do not invent a statutory day-count here. Public operator summaries often cite multi-month review windows for new applications; treat those as planning ranges until your proposal locks a submission schedule.

Operator checklist before you open a DIGEMAPS folder

1. Write “trial” and “commercial” on two pages if you still need human data in the Dominican Republic.
2. Name the local Authorized Representative before you sign an exclusive distribution LOI.
3. Confirm who pays for the filing — manufacturer-funded processing is how you keep control of the certificate.
4. Align Spanish labels and IFU to the sellable configuration, not an investigational kit.
5. Confirm ONAPI / trademark readiness and any DIGEMAPS pre-file checklist items for your class.
6. Budget telecom / RF tracks separately when the device is wireless.
7. Write the transfer-upon-demand clause with local counsel before the first commercial shipment.

Talk with bioaccess® when you need DIGEMAPS registration processed independent of the commercial channel — or when you are sequencing a Dominican FIH into a later commercial file without mixing the desks.