Ministry of Health · structured requirements

🇨🇷 Costa Rica medical device regulatory data

Explore the medical device requirements currently available for Costa Rica, organized by topic and linked to official sources.

5 facts4 dimensions2 official sourceslatest verification 2026-08-13

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

authorization.duration

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

change.available-outcomes

Outcomes: Prior Approval Amendment Or Variation
New Registration Or New Application
Description: Post-registration services include holder, manufacturer, indication, label, model/family and distributor changes.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

change.new-application-triggers

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

market-entry.representative-change

Path Code: Post Registration Holder Or Legal Representative Change
Fresh Registration: Usually No For Listed Change
Minimum Handover: manufacturer authorization
holder/legal representative records
registration file
local distributors
complaints/recalls
Spanish labels
Notes: Exact change type determines whether amendment or new registration is required.