Sponsors still write “Dominican Republic registration” as if DIGEMAPS were a customs stamp you buy after you pick a local reseller. It is not. A DIGEMAPS-licensed Dominican establishment has to file the registration under a power of attorney from the product owner, and that local establishment is the importer of record. DIGEMAPS’s device procedures separate the titular (the product owner) from the local representative, and they let the titular authorize co-distributors. If the distributor funds the filing and is named as titular, it usually controls 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, the Importer of Record guide, and our guide to titular, representative and co-distributors in the Dominican Republic. Operator guidance only. Not a quote and not legal advice.
One-sentence answer
Commercial sale in the Dominican Republic requires a DIGEMAPS sanitary registration, filed by a licensed Dominican establishment under a power of attorney from the product owner, under Ley 42-01, Decreto 246-06 (a medicines regulation that DIGEMAPS applies to productos sanitarios) and DIGEMAPS’s published procedures. A foreign manufacturer cannot file or import on its own, but DIGEMAPS’s device procedures let the product owner appear as titular with a local representative, add co-distributors by power of attorney, and change the representative or the titular through separate DIGEMAPS procedures.
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. A licensed local representative files and imports. More than one licensed Dominican company can be authorized under one registration through DIGEMAPS’s co-distributor procedure, but only with a power of attorney from the titular.
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.
Decreto 246-06 is written for medicines and has no device chapter, but DIGEMAPS lists it as the legal basis for registering productos sanitarios. A device-specific Reglamento de Productos Sanitarios y/o Dispositivos Médicos was published as a draft in January 2025; it is not in force. Changing the representative or the titular is a DIGEMAPS procedure, not a private vendor swap, and each change runs on a power of attorney from the titular. See titular, representative and co-distributors in the Dominican Republic for the documents each procedure asks for.
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 the risk level you declare in the dossier. No binding device class scheme is in force today; Classes I, IIa, IIb and III come from the January 2025 draft regulation, which is not in force. 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
- Power of attorney from the product owner to the licensed local representative, and that establishment’s DIGEMAPS registration
- Import story that matches the licensed representative or authorized co-distributor named on the registration — not a freight forwarder with a borrowed tax ID
- Post-market ownership agreed between the titular and the local representative
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.” If the distributor pays for the filing and is named as titular, it controls market access until DIGEMAPS approves a change of titular, and that change needs the original certificate and transfer documents from the current titular.
- 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 a DIGEMAPS-licensed Dominican establishment acts as representative and importer under a structure that can change on demand. bioaccess® does not act as registration holder, representative or importer of record in the Dominican Republic. DIGEMAPS publishes a response time of 90 working days per registration application; that is a service target, not a guaranteed approval date.
Operator checklist before you open a DIGEMAPS folder
- Write “trial” and “commercial” on two pages if you still need human data in the Dominican Republic.
- Decide who is titular and who is the local representative before you sign an exclusive distribution LOI.
- Confirm who pays for the filing — manufacturer-funded processing is how you keep control of the certificate.
- Align Spanish labels and IFU to the sellable configuration, not an investigational kit.
- Confirm ONAPI / trademark readiness and any DIGEMAPS pre-file checklist items for your class.
- Budget telecom / RF tracks separately when the device is wireless.
- Write the transfer-upon-demand clause with local counsel before the first commercial shipment.
To start, send your IFUs, your SKU list and your current certificates through our contact page. For the titular, representative and co-distributor rules, read titular, representative and co-distributors in the Dominican Republic.