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Dominican Republic medical device government fees

Row-level verified

DIGEMAPS current fee schedule, reviewed for 2026, in DOP.

3 fee lines100% exact amountscurrency DOPFX rates 2026-09-17reviewed 2026-09-16
Fee lineOfficial amountUSD equivalentFrequencyProvenance
Registro Sanitario de Productos Sanitarios — procedimiento simplificado, nuevo registro
The MSP service listing for the simplified procedure publishes RD$18,000.00 against the line 'Productos Sanitarios' by name, for a new registration; the same figure is published for a renewal. The legal basis cited on that page is Resolución No. 000020.
DOP 18,000$305Per registrationVerified
Registro Sanitario de Productos Sanitarios — procedimiento simplificado, renovación
Same MSP listing, 'Productos Sanitarios' line, renewal modality: RD$18,000.00. Eligibility for the simplified track rests on Resolución No. 000004 of 27 January 2016 and requires a Certificate of Free Sale plus a good-manufacturing-practices certificate from a listed WHO Strict Authority or PAHO/PARF regional reference authority.
DOP 18,000$305Per renewalVerified
Autorización de publicidad y promoción (productos sanitarios)
Advertising and promotion of sanitary products to the general public requires authorisation or notification from DIGEMAPS under the reglamento brought into force by Resolución 000033-15; the published cost is RD$1,000.00 per authorisation and no cost for a publicity notification, with a 25-business-day response time and one fee payment per brand or product.
DOP 1,000$16.95Per brand or product, per authorisationVerified
Government fees only — service and testing costs are separate
  • Dominican fees are set by product family, not by device risk class, so the low- and high-risk bands carry the same figure. The bands carry the only registration charge that an official source publishes against sanitary products by name: the simplified-procedure fee of RD$18,000.00, for a new registration and for a renewal alike.
  • Every amount published here is an exact figure printed in an official source and named for its product family at row level: the MSP simplified-procedure listing prices sanitary products at RD$18,000.00 by that name, and the DIGEMAPS advertising service page, whose scope covers medicinal, cosmetic, sanitary and personal-hygiene products, prices an authorisation at RD$1,000.00 and a publicity notification at no cost.
  • No amount is published here for the ordinary, non-simplified registration route. Its tariff sits in Resolución 000020, which could not be retrieved (digemaps.gob.do/descargas returns 404 and the wp-json media endpoint returns 401), and the only figure the DIGEMAPS sanitary-products registration and renewal pages print is RD$9,000.00 under the fixed unit label 'Para Medicamento' — a medicine figure on a sanitary-products service page, which cannot be read as the sanitary-products fee and is therefore not published. That is why this record carries three detail rows rather than five.
  • Payment is made by deposit or certified cheque to the Tesorería Nacional account at Banco de Reservas, and the receipt must be no older than three months.
  • A verified zero exists in this schedule: a publicity notification to DIGEMAPS carries no cost, unlike the RD$1,000.00 advertising authorisation.
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Exact amounts verified against the DIGEMAPS fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:dominican-republic:sanitary-registration-simplified-new