Costa Rica is the clearest express medical-device post-trial access statute in Latin America. Ley 9234 Art. 53(k) obliges free post-study provision of “el medicamento, dispositivo o procedimiento,” and Art. 28 sets duration at “mientras lo requieran.” If your protocol language still talks as if PTA were medicines-only, you are drafting against the wrong country.
I am Julio Martinez-Clark, CEO of bioaccess®. This page is the device cut of Costa Rica PTA. For the regional mandate list, use Which LATAM countries mandate post-trial access for medical devices?. For the operator map, use Post-trial access in Latin America: the operator’s map.
Article 53(k) — what the text actually covers
Art. 53(k) is not an inference from a medicines chapter. It names medicamento, dispositivo o procedimiento in the free post-study provision duty. That is why Costa Rica sits in the “express device mandate” column on our published map, beside Brazil Art. 37, Chile Art. 111 C, and Peru’s device-reaching Reglamento language — and ahead of jurisdictions that stay silent or medicines-framed.
For a Class II/III investigational device, that sentence is the planning input: assume free continuation supply is on the table for subjects who still need the intervention after the last protocol visit, unless a lawful exit in the statute applies. Do not wait for a hospital ethics committee to invent the duty for you; put it in the protocol and the budget before first implant.
Duration under Article 28
Art. 28’s “mientras lo requieran” is an open clinical need clock, not a neat “database lock + 90 days” commercial habit. Budget, import, and complaint handling have to survive that runway. Compare Brazil’s in-force five-year commercial-availability cap under Lei 14.874 Art. 33 VI, or Argentina’s twin structure of substantive duty plus renewable import authorization under Disp. 12792/2016 — Costa Rica’s duration clause is closer to open-ended clinical need than to a fixed statutory ceiling.
Open duration is not an invitation to invent infinite liability in a CRO work order. It is a signal to define clinical “still requires,” complaint ownership, and who decides discontinuation when the treating physician says the intervention is no longer needed.
The planning problem: obligation without a named post-trial import path
Art. 55 addresses importation in the pre-study / approved-investigation lane. The statute does not hand you a tidy, labeled “post-trial import license” chapter the way some neighbors do with PTA-specific import or ofício mechanics. That gap is the operator issue:
- Duty: free provision while subjects require the product or procedure.
- Pathway: not spelled out as a standalone post-trial import track in the same way Brazil RDC 38/2013 or Panama’s import-permit-extension framing appears in our published pillars.
Sponsors who only paste Art. 53(k) into the protocol and leave logistics blank discover the gap at close-out. Build the import, customs, cold-chain, and complaint path into the PTA work order before first patient — not after the last monitor visit.
How Costa Rica compares on devices
| Country | Device reach | Duration signal | Operator note |
|---|---|---|---|
| Costa Rica (Ley 9234) | Express: medicamento, dispositivo o procedimiento (Art. 53(k)) | “Mientras lo requieran” (Art. 28) | Strong text; import pathway must be engineered |
| Brazil (Lei 14.874) | Art. 37 reaches devices/ATMPs; RDC 38 is the practical import/assistance mechanism for many files | Interruption grounds incl. five-year commercial cap (Art. 33 VI) | Statute + RDC mechanics |
| Chile (Art. 111 C) | Express device-capable Código Sanitario duty | Open-ended patient need; successor on registro holder | Supply + M&A diligence |
| Peru (DS 021-2017-SA) | Device-reaching Reglamento; ANM/DIGEMID practice for case-by-case route | Benefit-linked continuation language | Art. 117 document set on the case-by-case path |
| Colombia | No PTA statute on our published map | N/A | Do not invent a Colombian PTA duty from INVIMA trial rules |
Use that table for protocol country selection conversations. Do not collapse “express device mandate” into “easy logistics.”
What to put in the Costa Rica PTA work order
- Subject of supply. Device, accessory, procedure support, explant/replacement rules — named, not “investigational product” as a vague bag.
- Exit conditions. Map the statutory exits in Art. 53(k) / related articles to protocol language counsel will actually sign.
- Import and release path. Even if the statute is thin on post-trial mechanics, the work order must name who files, who holds inventory, and who releases units after database lock.
- Complaint and vigilance handoff for units still in subjects after the trial CES.
- Sponsor accession. If a CRO or local operator signs operational pieces, the sponsor still owns the statutory duty — put accession in writing (same architecture principle as our legal pillar).
- Budget line that survives close-out. PTA that is only a protocol sentence without a cost center dies in finance review the week after LPLV.
FIH vs commercial registro — keep the tracks apart
Costa Rica PTA is a trial-aftermath patient duty. It is not a shortcut to commercial registro, and it is not a substitute for ethics and authority authorization to start the investigation. Same rule we publish for Panama, El Salvador, Argentina, and Peru: trial authorization and selling license are different petitions. PTA sits on the trial side until a commercial holder path exists — and even then Chile-style successor problems show why you track who holds what.
If you are choosing among Costa Rica, Panama, Brazil, and Chile for an early device cohort with a real continuation risk, start from the mandate text, then stress-test import and complaint logistics. bioaccess® will tell you whether the protocol’s PTA paragraph matches Ley 9234 or whether it still reads like a medicines template pasted from another region. Related: Does Panama require post-trial access?, LATAM market access, and the operator map linked above.
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