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How to Run a First-in-Human Medical Device Clinical Trial in Costa Rica: The Regulatory Pathway

Written by

Julio Martinez-Clark

in

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General information, not legal advice. Requirements change and each ethics committee applies its own procedures. Confirm with the scientific ethics committee (CEC), CONIS and Costa Rican counsel before you commit a timeline. Last verified 28 October 2026.

This is our one-page regulatory pathway for a first-in-human (FIH) medical device clinical trial in Costa Rica. It is written for sponsors who already have a protocol and want to know who approves what, in what order, what it costs, and where the time goes. Every rule below is linked to the public source we read it from. Where the law is silent, or where we only have experience and no published data, we say so.

Key takeaways

  • One law, one regulation. Clinical research in humans is governed by Ley 9234 (Ley Reguladora de Investigación Biomédica, 2014) and its regulation, Decreto Ejecutivo 39061-S (2015, as amended by 39533-S).
  • The ethics committee is the gate. A CONIS-accredited CEC must approve the protocol in writing before anything starts. Each committee sets its own submission format, fees and meeting calendar, so ask the CEC that will review your study.
  • CONIS registration plus a 3% levy. The approved study is registered with CONIS, the national health research council under the Ministry of Health. At registration the principal investigator pays CONIS 3% of the total study budget (Ley 9234, art. 60).
  • Insurance must be enforceable in Costa Rica, and the Spanish consent form has to describe the policy.
  • Device import comes last. Investigational units may be imported only after CEC approval and CONIS registration (Decreto 39061-S, art. 55).
  • Public (CCSS) hospitals add a second layer: their own regulation, a central CCSS committee, a contract signed by the CCSS and CCSS tariff-based cost recovery. Plan for materially longer than a private site.

The legal framework

  • Ley 9234 regulates biomedical research with humans in both public and private settings and creates CONIS (official SCIJ text).
  • Decreto 39061-S sets out the submission package, committee deadlines, the levy and the rules for importing investigational products (consolidated copy; official SCIJ record).
  • Reglamento de Investigación Biomédica de la CCSS (La Gaceta, Alcance 50, 10 March 2021) applies only at CCSS public facilities (PDF from CENDEISSS).
  • CONIS lists all three on its legislation page.

An investigational device does not need Costa Rican sanitary registration to be used in an approved study. The regulation authorizes the import and use of registered and unregistered products for research purposes, limited to studies that are properly approved and registered (Decreto 39061-S, art. 53). Commercial registration later is a separate file. See how to register a medical device with MINSA.

Step 1: Choose the site, and with it the committee

In Costa Rica the site and the ethics committee choice go together:

  • Private hospital or research center. The study normally goes to that institution’s own CONIS-accredited CEC, or to another accredited CEC if it has none. Each committee publishes, or will send you, its own forms, fees and session dates. Ask that CEC directly what it requires; there is no single national form. See the table of private and university CECs below.
  • CCSS public hospital. Proposals go to one of the CCSS’s central CECs (CEC-CENTRAL), not to a committee chosen by the sponsor (CCSS regulation, art. 14). See the CCSS section below.
  • Is a device FIH “Phase I”? Ley 9234 makes the Ministry of Health’s own committee (CEC-MS) the only committee in the country that can approve Phase I and bioequivalence studies (art. 46, as summarized in the Ministry’s CEC-MS notice). The law defines the phases in drug and vaccine terms. Whether a given device FIH is routed to CEC-MS or can be reviewed by a site CEC should be confirmed in writing with CONIS or the committee before you plan the calendar.

Every investigator must be accredited by CONIS and hold a Good Clinical Practice course certificate less than three years old (Decreto 39061-S, art. 44(z)–(aa)).

Step 2: Build the Spanish submission package

Decreto 39061-S art. 44 lists the package for any experimental, clinical or interventional study. For a device FIH the items that usually drive the schedule are:

  • Protocol and investigator’s brochure in the original language plus an official Spanish translation, dated and versioned (art. 44(b)–(c)).
  • Informed consent in Spanish, in plain language (art. 44(d)). Ley 9234 art. 11(f) requires it to address the insurance policy.
  • IDE or equivalent, or a copy of an approval letter from FDA, EMA or another recognized agency, unless CONIS grants a qualified exception or the research is of Costa Rican authorship (art. 44(h)).
  • Device classification by FDA, EMA or another recognized agency (art. 44(i)).
  • Evidence the device was made under good manufacturing practice, plus a sterility certificate for sterile devices (art. 44(r)).
  • The investigator–sponsor contract and the study budget (art. 44(l)–(m)). The budget matters twice: the CEC reviews it, and the 3% CONIS levy is calculated on it.
  • Insurance policies and sponsor commitments on injury treatment and compensation (art. 44(jj)–(ll)).
  • A commitment to provide the study product free after the trial where it proved beneficial (art. 44(mm); Ley 9234 arts. 28 and 53). See our note on post-trial access for devices.
  • Site description, team CVs, CONIS accreditations and conflict-of-interest declarations (art. 44(p), (z)–(cc)).
  • A sworn statement naming any CRO (OIC) or site management organization (OAC) and its CONIS accreditation (art. 44(tt)).

Step 3: Insurance enforceable in Costa Rica

A civil liability policy is mandatory (Ley 9234, art. 31). It must be valid and enforceable in Costa Rica, through an insurer with branches or service centers in the country (Decreto 39061-S, art. 14(f)). It covers participants from consent signature until three years after their participation ends, and the sponsor must also cover the investigator and team. Each participant receives proof of the policy with the consent form. There is no monetary minimum in the law. Full detail: Costa Rica clinical trial insurance under Ley 9234, and the country-by-country LATAM clinical trial insurance guide.

Step 4: CEC review

Committees must rule on approval, rejection or renewal within one calendar month from the business day after the submission (Decreto 39061-S, art. 42). In practice that clock only helps if the package is complete. Query cycles, translation fixes and committee session calendars add time, and none of that is published. Resolutions can be appealed to the committee and then to CONIS.

Step 5: CONIS registration and the 3% levy

Once the CEC approves, the study is registered with CONIS. To register, the principal investigator pays CONIS 3% of the total research budget, and a copy of the signed contract, reviewed by the CEC, goes to CONIS (Ley 9234, art. 60, as quoted by the CCSS’s CENDEISSS FAQ). CONIS verifies the payment, which goes into a CONIS collection account (Decreto 39061-S, art. 49). Studies declared of public interest or a health priority can apply for an exemption (Ley 9234, art. 61; Decreto art. 50). A sponsored device FIH normally will not qualify. Budget the levy from day one and keep the CEC budget and the CONIS budget identical.

Step 6: Institutional authorization

CEC approval does not by itself open the site. Under Ley 9234 the health center where the study runs, public or private, must also authorize it. At a private site this is usually a letter from the institution’s legal representative or medical director. At a CCSS hospital it is a multi-office process, described next.

Step 7: Import the investigational devices

Investigational devices may be imported only after the study is approved by the CEC and registered with CONIS. Before the first shipment, the investigator or importer files with CONIS a list of the units and supplies needed for the whole study, approved beforehand by the CEC. CONIS uses it to issue the sanitary authorization for each customs entry, and any increase needs a new approval (Decreto 39061-S, art. 55(a)–(b)). Every product must be traceable through the supply chain to the site (art. 54).

Public CCSS hospitals versus private sites

The Caja Costarricense de Seguro Social (CCSS) runs the public hospitals. Sponsored studies are allowed there, but under an extra regulation with its own committees, offices and contract:

  • Pre-review sign-offs. The service head and the hospital’s medical director must sign a “no objection” on the application before the CEC sees it (CCSS regulation, art. 73(b); CENDEISSS requirements). The regulation sets no deadline for this step.
  • Central CCSS committee reviews the protocol: 30 calendar days for full-committee review from a complete submission, 15 for expedited review (arts. 14, 17, 18). A CCSS review fee applies; for the second half of 2026 it is ₡1,442,664 for a first submission (CENDEISSS tariffs).
  • A CCSS employee on the team. Every study run in the CCSS must include at least one CCSS staff member, accredited by CONIS, as principal investigator or sub-investigator (art. 13). The CENDEISSS checklist adds that if the principal investigator is not a CCSS employee, a CCSS employee must be named sub-investigator and shares responsibility for the study with the principal investigator (CENDEISSS requirements, item 1). An investigator who is not on CCSS staff cannot run a study at a CCSS hospital alone.
  • Contract before approval. For sponsored studies, the contract between the investigator, the CCSS, the sponsor and any CRO or site-management company must be signed before the CEC authorizes the protocol (art. 12).
  • Conditions for industry studies: the study must be of institutional interest, must not affect patient care, must use idle capacity, and must benefit the CCSS and participants (art. 27).
  • Cost recovery. The sponsor pays the CCSS direct, indirect and administrative costs under the CCSS tariff model. Costs not in the tariff are set by the CCSS cost-accounting area, which has up to 30 calendar days (arts. 28, 77).
  • A three-party contract between the CCSS (signed by the CENDEISSS director), the investigator and the sponsor or CRO. The regulation gives 10 business days to draft it, 5 for legal review and 5 to sign (arts. 31, 69(i), 70(f), 75).
  • Sponsor paperwork. The sponsor must be current with CCSS obligations, file sworn statements on the origin of funds and, if foreign, provide apostilled corporate documents and powers of attorney with official Spanish translations (arts. 29–30).
  • Start authorization by the hospital authority within 5 business days of the CEC’s request (art. 73(c)).

CCSS central CEC: the rules, the package and the fees

The CCSS rules come from its Reglamento de Investigación Biomédica (La Gaceta, Alcance 50, 10 March 2021). The articles that matter most for a sponsored device study:

  • Art. 12, approval. Research is allowed in CCSS units only if it does not disrupt the unit and respects patients’ rights. It needs approval by a CONIS-accredited CCSS committee and authorization by the competent CCSS authority, plus CENDEISSS authorization (through its research area, AISSS) and CONIS registration. If a hospital director objects, the matter goes to the CCSS General Management for a final decision. For sponsored studies, the contract between the investigator, the CCSS, the sponsor and any CRO or site-management company must be signed before the committee authorizes the protocol.
  • Art. 13, CCSS staff. At least one CCSS employee, accredited by CONIS, must be principal investigator or sub-investigator. The only exception is research for an academic degree, which needs a CCSS tutor instead.
  • Art. 14, where to submit. Proposals go to one of the CCSS central committees (CEC-CENTRAL). Its technical secretariat checks that the package is complete and on the official forms.
  • Art. 27, conditions for sponsored studies. The study must be of institutional interest; must not affect patient care (study tasks during normal care hours can be done by trained third parties with the unit’s authorization); must use idle capacity of facilities and equipment; must benefit the CCSS and participants; must recognize the CCSS in publications; and must have a signed contract.
  • Art. 28, payments. Sponsored studies pay the CCSS direct, indirect and administrative costs under the CCSS health-insurance tariff model, based on the total study budget. Items not in the tariff are priced by the CCSS cost-accounting area within 30 calendar days. The money goes to the CENDEISSS research and innovation fund.
  • Art. 73, the hospital authority. The head of the hospital gives the administrative no-objection before committee review, coordinates the start within 5 business days of the committee’s request, informs the service head, and grants electronic-record access to authorized investigators.

The submission package. The CENDEISSS checklist for interventional studies has 22 protocol items. In summary:

  • An investigator’s request letter (naming a CCSS sub-investigator if the principal investigator is not CCSS staff).
  • CCSS forms AP-IA to AP-VA: application with the service head’s and medical director’s no-objection signatures for each hospital, protocol, protocol summary, lab and pathology tests, and budget.
  • Investigator’s brochure in the original language plus an official Spanish translation, and the case report form.
  • IDE (or equivalent) or an FDA, EMA or other recognized approval letter; the device’s classification by a recognized agency; Costa Rican registration certificates if the device is already registered.
  • List of countries and sites with expected enrollment per site; approval by an accredited committee in the sponsor’s country if it has sites there; history of submissions to other Costa Rican committees.
  • GMP evidence and, for sterile devices, a sterility certificate.
  • Site licences, sample-transfer agreements, external-lab licences, and recruitment materials.
  • Spanish informed consent (and assent if needed), dated and versioned.
  • For every team member: signed CV, ID, professional licence, a CONIS-endorsed GCP certificate under three years old, CONIS accreditation, and signed commitments and conflict-of-interest declarations.
  • From the sponsor: proof of payment of the review fee; certification that the sponsor is current with CCSS social-security contributions; the investigator-sponsor contract covering all study costs; injury compensation with a policy valid at least two years after the study ends; liability insurance for the investigator and team; free post-study treatment where shown beneficial (Ley 9234 arts. 28 and 53); commitments to report final results and to involve the investigator in publication; and a sworn statement on any CRO or site-management company involved, with its CONIS accreditation.

Fees for the second half of 2026 (CENDEISSS tariffs; they include 25% administrative costs and are paid by SICO voucher or bank transfer after requesting the payment form from the AISSS):

Request Fee
First review ₡1,442,664
Amendment ₡52,454
Annual renewal ₡849,663

CENDEISSS states that committee review takes two to four weeks from receipt of a complete submission. It does not publish how long the sign-offs, contract and cost steps take in practice.

How long does a CCSS approval take? On paper, the regulation’s own deadlines add up to roughly three months after a complete submission. That excludes dossier preparation, the director’s sign-off, query cycles, corporate paperwork and CONIS registration. The CCSS does not publish actual approval times, and neither does any public source we found, so plan for materially longer than a private site and ask the hospital for its recent track record. CENDEISSS itself states that committee review takes two to four weeks from receipt of a complete submission; the institutional steps around it are what add time. For context, no new clinical trials could start in Costa Rica from February 2010, when the Constitutional Court required a law, until Ley 9234 in April 2014, and until the CCSS adopted this regulation in March 2021 trials could only run in the private sector (Salud y Fármacos, 2020 report).

Where industry-funded trials actually run in Costa Rica

We queried the ClinicalTrials.gov API on 28 October 2026 for interventional studies with an industry lead sponsor and at least one site in Costa Rica, then classified each named Costa Rican site as CCSS/public or private:

  • 185 industry-funded interventional studies list a Costa Rican site. 84 name at least one identifiable site; the rest show only placeholders such as “Pfizer Investigational Site”.
  • None of the 84 lists a CCSS hospital or clinic. Named sites are private hospitals and research centers such as CIMCA, ICIMED, Hospital Clínica Bíblica, Hospital Metropolitano, Hospital CIMA, Clínica 20/20 and Policlínico San Bosco.
  • Of the 68 started in 2016 or later, 62 name a site, and none is at a CCSS facility.
  • All 16 industry-funded device studies (all started 2020 or later) are at private sites.
  • The same search across all funders does find CCSS hospitals (Hospital México, San Juan de Dios, Calderón Guardia) in 6 studies, all sponsored by the CCSS, universities or research networks, so the method does pick up public sites when they are listed.

Caveats: ClinicalTrials.gov does not capture every study approved in Costa Rica, older records often hide site names, and our public/private split is based on facility names. It is a snapshot of where sponsors have registered their Costa Rican sites, not an official count.

Method. One ClinicalTrials.gov API v2 query per country, using AREA[LocationCountry], AREA[LeadSponsorClass]INDUSTRY and AREA[StudyType]INTERVENTIONAL, pulled on 28 October 2026. For each study we kept only sites in that country, set aside placeholder names (for example “Research Site” or “Investigational Site Number…”), and classified the rest as public or private by facility name. Public means a social-security, ministry, national-institute, public-university or other state hospital or clinic (in Costa Rica, the CCSS network). “Device” means at least one intervention of type Device. “Since 2016” uses the study start date.

Public versus private sites in nearby countries

The same method applied to four other countries. The figures show the share of studies that name a site and have at least one public site:

Country Industry interventional studies With a named site With at least one public site Since 2016: with a public site Device studies: with a public site
Costa Rica 185 84 0 (0%) 0 of 62 (0%) 0 of 16 (0%)
Panama 290 150 18 (12%) 9 of 83 (11%) 1 of 35 (3%)
Colombia 1,359 700 76 (11%)* 55 of 476 (12%)* 1 of 48 (2%)*
Chile 1,819 900 292 (32%) 170 of 633 (27%) 24 of 79 (30%)
Mexico 3,635 1,772 806 (45%) 531 of 1,215 (44%) 36 of 102 (35%)

In short, public sites are rare for industry-funded trials in Costa Rica, Panama and Colombia, and more common in Mexico and Chile, where national institutes, social-security hospitals and public university hospitals often take part. Caveats: name-based classification is approximate; *Colombia’s public hospitals have many naming patterns, so its figures are a lower bound; placeholder site names hide a large share of older records in every country; and the registry does not capture every study approved locally.

Published sources on public-sector research in Costa Rica

  • The 2010–2014 halt. In 2010 the Constitutional Court (ruling 2010-1668) annulled the decree that regulated research on humans and suspended new studies until a law was passed. Ley 9234 was approved in April 2014 and its regulation (Decreto 39061-S) was published in July 2015. Source: Homedes N. and Ugalde A., “Costa Rica: Los Comités de Ética y la Protección de los Participantes en Investigación Biomédica,” Salud y Fármacos, December 2020.
  • Private sector only until 2021. The same report states that, as of November 2020, clinical trials could only be done in the private sector because the CCSS had not yet approved its internal regulation. It also documents that the CCSS reviewed sponsored interventional studies through a central committee from 2005 on.
  • The CCSS regulation. The CCSS Reglamento de Investigación Biomédica was published on 10 March 2021 and is the current framework (see above).
  • CENDEISSS research staffing. Semanario Universidad (6 November 2024) reported that on 6 June 2023 the CCSS board withdrew authorization to use vacant resident positions to support research at CENDEISSS. A later internal audit found no irregularities and warned that the withdrawal affected ongoing research projects.
  • Size of the sector. El Financiero (14 May 2022) reported about 200 studies in the private sector and more than 400 in the public sector, and that industry groups were then working to make the contract and financial steps of the CCSS regulation operational. The article does not say how many of the public-sector studies were industry-funded clinical trials; most are likely academic or observational. We found no official count of industry-funded trials approved by the CCSS since 2021.

CONIS-accredited private and university ethics committees

A private site normally uses its own CEC or any other CONIS-accredited CEC. These are the non-CCSS, non-government committees on CONIS’s accredited list as of 28 October 2026. Fees and calendars change; confirm with the committee before you budget. Where a committee does not publish an item, we say so.

Committee Type Published requirements Published fees Meetings / turnaround Contact (per CONIS and the committee)
CEC Hospital Clínica Bíblica Private hospital Not published online Not published Not published Dra. Jessie Orlich Montejo; (506) 2522-1000 ext. 8116; investigacionhcb@clinicabiblica.com (CEC notice)
CEC-UCIMED (Universidad de Ciencias Médicas) Private university; founded 2002 Online submission platform and full form set for interventional studies, including the CONIS 3% calculation form (CEC-UCIMED) Tariff document linked; amount not shown on the page Not published Dr. José Pablo Díaz Madriz; cec@ucimed.com; (506) 2291-6754
CEC-UH (Universidad Hispanoamericana) Private university Procedures, forms and checklist; submit by email (CEC-UH) Interventional (2024 tariff): first review US$2,200 (US$2,486 with VAT); renewal US$1,150, protocol amendment US$350 and each additional site US$2,000 (before VAT). Pay within 7 business days of submission (tariff) Sessions in the first week of each month; review within 30 calendar days Dr. Francisco Rodríguez Fallas; cecuh@uh.ac.cr; (506) 2106-3199
CEC-UNIBE (Universidad Iberoamericana) Private university; since 2008 Submission checklist and forms posted (CEC-UNIBE) Not found online Not confirmed Lic. David Torres Fernández; (506) 2240-0400 ext. 2203
CEC-ULatina (Universidad Latina) Private university Accepts phase II, III and IV studies only; separate requirement guides for observational and interventional studies (CEC-ULatina) Published list (fees): interventional protocol amendment ₡196,000 (₡252,000 with consent changes); observational first review ₡1,064,000. No interventional first-review fee is shown Monthly. The page gives both “second Monday” and “last Wednesday, 2 p.m.”; documents are due by noon the Wednesday before the session Dr. Norbel Román Garita; cec.ulatina@ulatina.cr; (506) 2207-6017 ext. 16024
CEC-USP (Universidad Santa Paula) Private university Requirements list and FO-05 checklist (CEC-USP) Fee schedule referenced, not online File at least 7 business days before an ordinary session; three reviewers have 10 business days Dra. Marlene Roselló Araya; (506) 2216-4400
CEC Fundación INCIENSA (FUNIN) Foundation linked to the public INCIENSA institute Nothing found online Not published Not published Dr. Alejandro Calderón Céspedes; (506) 2668-1125 ext. 1348

None of these committees states publicly whether it reviews device first-in-human studies. Ley 9234 reserves Phase I approval to the Ministry of Health’s committee (CEC-MS), and the law defines phases in drug terms, so confirm in writing with CONIS or the committee how a device first-in-human study will be routed. Public universities (UCR, UNA), INCIENSA, the Ministry of Health and CCSS hospitals also have accredited committees; they are not listed here.

Hospital CIMA and Hospital Metropolitano do not appear on the current CONIS list, so studies at those hospitals go to another accredited CEC.

Step-by-step timeline

Step Who Published clock What to plan for
1. Site, CEC and Phase I routing Sponsor, CRO, site None Get the CEC choice (or CEC-MS routing) confirmed in writing
2. Spanish package, translations, contract, budget Sponsor, CRO, PI None Usually the longest controllable step
3. Costa Rica–enforceable insurance Sponsor, local broker None Start early; the consent form depends on it
4. CEC review Accredited CEC 1 calendar month (Decreto 39061-S art. 42); CCSS 30 days full review (CCSS art. 17) Add at least one query cycle and the committee’s session calendar
5. CONIS registration and 3% levy PI Not published Confirm the current procedure with CONIS
6. Institutional authorization Site; CCSS offices at public sites Private: none. CCSS: contract 10+5+5 business days, costs up to 30 days, start 5 business days CCSS adds the director sign-off before review plus contracting and cost steps
7. Device import Importer, CONIS Not published Only after steps 4 and 5; quantity list approved by the CEC
8. Site initiation and first patient Sponsor, CRO, site None Only once steps 4–7 are complete

For a week-by-week planning view at a private site, see our Costa Rica FIH activation calendar.

Document checklist

  • Cover letter from the PI requesting review
  • Protocol and investigator’s brochure, original plus official Spanish translation
  • Spanish informed consent describing the insurance policy
  • IDE or equivalent, or FDA/EMA/other agency approval letter (or CONIS exception)
  • Device classification, GMP evidence and sterility certificate
  • Investigator–sponsor contract and full study budget
  • Costa Rica–enforceable insurance policies and sponsor indemnity commitments
  • Post-trial access commitment
  • CVs, IDs, professional licenses, GCP certificates and CONIS accreditations for the team
  • Site description and habilitation certificate
  • Recruitment materials and the emergency and adverse-event plan
  • CRO/OAC sworn statement and accreditations
  • Investigational device quantity list for CONIS (before import)
  • At CCSS sites: director and service-head no-objection, CCSS co-investigator, CCSS fee receipt, corporate and origin-of-funds documents, CCSS contract

Using Costa Rica data with the FDA

If the data will support a U.S. submission, 21 CFR 812.28 lets FDA accept a foreign clinical investigation not conducted under an IDE if it followed good clinical practice, including review and approval by an independent ethics committee and informed consent, and if FDA can validate the data through an on-site inspection if needed (eCFR). A CONIS-accredited CEC approval and an ISO 14155-compliant conduct plan are how most sponsors meet that standard.

FAQ

Who sets the requirements for my study?
The law and regulation set the minimum. The CEC that reviews your protocol applies them and adds its own forms, fees and calendar. If you already work with specific hospitals, ask their committee what it needs.

Do I pay the Ministry of Health?
The 3% levy on the total study budget is paid to CONIS, which sits under the Ministry of Health, when the approved study is registered. CEC review fees are separate and set by each committee.

Do I need a U.S. IDE first?
The submission package asks for an IDE or equivalent, or an approval letter from FDA, EMA or another recognized agency, unless CONIS grants a qualified exception. Discuss your situation with the committee early.

Is a public CCSS hospital slower than a private one?
It has more steps: director sign-off, a central CCSS committee, cost setting and a CCSS contract. No public data on actual durations exists, so plan for longer and ask the hospital.

Does the device have to be registered in Costa Rica?
No. Unregistered products may be imported and used for properly approved and registered research.

Related guides

How bioaccess® helps

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Last verified: 28 October 2026. Written by Julio G. Martinez-Clark, CEO of bioaccess®.

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