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Ministry of Health · Americas

Costa Rica medical device regulatory resources

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8 free resources24/25 requirements covered3 regulations trackedAug 2026 fees reviewed
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Medical device regulations

Browse official Ministry of Health regulations and guidance documents.

Government registration fees

Review current Ministry of Health application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely Ministry of Health pathway, government fees, dossier preparation time, review timeline, and registration steps.

AI medical device classifier

Describe your device and get a preliminary Ministry of Health risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Costa Rica requirements.

Medical device regulation news

Follow recent Ministry of Health policy, guidance, safety, and compliance updates.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Registration timeline

Compare official and realistic MINSA approval times by device class and pathway.

Structured regulatory requirements

Explore all 55 source-linked facts →

24 of 25 research dimensions currently covered · 12 official sources · latest verification 2026-09-07

Market entry

D01

Authority & regime

Verified
Competent authority
The Ministerio de Salud de Costa Rica is the national regulatory authority (Autoridad Reguladora Nacional) responsible for the regulation, registration and control of medical devices (equip…
National tecnovigilance center
The Centro Nacional de Tecnovigilancia (CNTV), seated in the corresponding Ministerio de Salud organizational unit, coordinates the National Tecnovigilance System and receives adverse event…
2 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
Current legal framework
Medical devices are governed by technical regulation RTCR 505:2022 (classification, registration, importation, labeling, advertising, vigilance and control), approved by Decreto Ejecutivo N…
Complementary decrees
Satellite instruments referenced by RTCR 505:2022: Decreto 37988 S (Regístrelo portal, incl. review deadlines), Decreto 32780 (EMB fees), Decreto 39342 S (Sistema Nacional de Tecnovigilanci…
3 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
Device definition (EMB)
Equipo y Material Biomédico (EMB): any instrument, device, equipment, material or other article, used alone or in combination (including software involved in its operation), intended by the…
IVD definition
In vitro diagnostic devices (Equipo para diagnóstico "in vitro") are EMB including their reagents, calibrators, controls and consumables intended to examine or diagnose from samples or flui…
4 source-linked facts
Checked 2026-08-25
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D05

Registration pathways

Verified
Class 1 exemption
Class 1 EMB do not require sanitary registration for marketing and use, but import, labeling, advertising, vigilance and control requirements still apply to them. The Ministry trámite page…
Market-access route
All EMB may only be manufactured, imported, marketed or distributed in Costa Rica if they hold the respective sanitary registration; applications for registration, renewal and post registra…
3 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
Equivalence-based reduced dossier
Under WTO TBT Article 6.1 principles, the Ministry may accept conformity assessment results of registration systems of foreign governments that have completed the equivalence procedure in A…
Central American registration recognition
The Regístrelo regulation defines 'Reconocimiento' as the procedure by which a sanitary registration issued by a regulatory authority that is a member of the Unión Aduanera Centroamericana…
2 source-linked facts
Checked 2026-08-25
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D07

Economic-operator roles

Verified
Holder and representative changes
Post registration changes distinguish: change of holder (requires legal document signed by previous and new holder, new representative power, new labels, manufacturing contract, free sale c…
Registration holder
The titular del producto is the natural or legal person owning an EMB marketed under a specific name or brand, legally answerable to the national regulatory authority; the holder is respons…
4 source-linked facts
Checked 2026-08-26
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D08

Establishment, import & distribution

Verified
Establishment operating permit
The manufacturer (for domestically manufactured products) or the importer (for foreign products) must hold a valid sanitary operating permit (permiso sanitario de funcionamiento) matching i…
Personal-use IVD sales restriction
Personal use in vitro diagnostic EMB may only be sold by mail order or telematic procedures through establishments holding a Ministry of Health permit for their commercialization.
2 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Class 2 registration dossier
Class 2 EMB registration requires: Regístrelo application form digitally signed; valid operating permit (national products) or Certificate of Free Sale (imported products, legalized/apostil…
Class 3 additional dossier
Class 3 EMB must additionally submit detailed clinical evidence demonstrating safety and efficacy: clinical evaluation document by the manufacturer; preclinical studies if applicable; clini…
4 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
RegĂ­strelo single window
All registration, renewal and post registration change applications must be filed through the Regístrelo platform (www.registrelo.go.cr), a 24/7 online single window connecting the public i…
Digital signature requirement
The application form must be digitally signed by the product holder or its legal representative or a person authorized by the representative; digitally signed documents must meet Banco Cent…
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Label and IFU language
EMB labeling must contain the required information in Spanish; if the original label is in another language, a complementary (supplementary) label translating the mandatory information is p…
Mandatory label content
EMB labels must show: true specific product name; intended purpose/use; name or tradename/logo and country of the holder; name or tradename/logo and country of the manufacturer; product ide…
3 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
GMP certificate requirement and suspension
The dossier must include a manufacturer GMP certificate (or its equivalent in the country of origin) issued by that country's health authority or authorized entity, covering all establishme…
1 source-linked fact
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
Medical electrical evidence
Electrical safety
SUTEL mobile-terminal or free-band homologation
Wireless / radio
Decree 24037-S ionising-radiation construction, import and operation authorisation
Radiation
3 maintained overlays
Checked 2026-09-07
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D15

Review clocks

Verified
Class 1 · MINSA registration
2-4 months
Class 2 · MINSA registration
2-4 months
Class 3 · MINSA registration
2-4 months
4 maintained pathways
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Registration validity
EMB sanitary registration is valid for five years, without prejudice to the Ministry's cancellation or modification powers under Ley N° 5395 (Ley General de Salud).
Renewal requirements
Renewal grants a period equal to the initial registration; before expiry the holder or legal representative must file via Regístrelo: renewal form, current legal representative power (if ex…
3 source-linked facts
Checked 2026-08-26
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Lifecycle & post-market

D17

Change control

Verified
Change-control outcomes
Changes to registration conditions require approval by the national regulatory authority BEFORE implementation, except changes declared to be notification type; applications use the Regístr…
New-application triggers
A change to the product that entails a variation in risk classification is considered a new product and requires a new registration (per class requirements in numerales 11/12/13); a change…
4 source-linked facts
Checked 2026-08-26
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D18

UDI, listing & traceability

Verified
Product identification on label
EMB labels must bear the product identification code (or declared model), the lot number, and the EMB registration number except for products exempt from registration.
Traceability duties
Manufacturers, importers and distributors must implement a traceability system to follow EMB through the commercialization, supply and use chain, with special emphasis on implantables, avai…
2 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical evidence requirements
Class 3 and 4 registrations require clinical evidence composed of the manufacturer's clinical evaluation document, preclinical studies where applicable, human clinical studies (or, for well…
IVD performance evidence
For IVDs, comparative investigative performance tests performed on the EMB using human samples representative of intended users under conditions similar to expected use may be submitted as…
2 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
Donated devices
Donations of EMB are within the regulation's scope, and any use of a donated EMB that has not been approved by the Ministry of Health under the established requirements and procedures is pr…
Unregistered devices for clinical research
Sanitary authorizations for customs release (desalmacenaje) of unregistered EMB exclusively for clinical research purposes are excluded from the application of RTCR 505:2022.
2 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Periodic safety reports
Manufacturers, importers and distributors must prepare and send periodic EMB safety reports to the CNTV: every 6 months during the first 2 years of marketing in the country; every year from…
Tecnovigilance unit and responsible professional
Manufacturers, importers and distributors must design and implement an Institutional or Company Tecnovigilance Unit to identify, record, evaluate and manage adverse event reports for the EM…
2 source-linked facts
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Serious event reporting deadline
Serious adverse events and incidents (those that may lead to or endanger life or cause serious deterioration of health, including life threatening disease or injury, damage to bodily functi…
Quarterly reporting and sanctions
Information on all adverse event and incident reports (serious and non serious) must be presented quarterly in consolidated form by the manufacturer's, importer's or distributor's tecnovigi…
2 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
Voluntary recall notification
Any voluntary recall meeting Class I or Class II criteria must be notified to the Ministry using the website form signed as sworn declaration, within a maximum of 5 business days from ident…
Recall execution and final report
Every recall (voluntary or Ministry ordered) must be executed within no more than 30 business days from identification of the problem unless the Ministry sets a different period (extensions…
3 source-linked facts
Checked 2026-08-25
Open details →
D24

Advertising, claims & promotion

Verified
Advertising framework
EMB advertising must comply with the 'Reglamento para la autorización y control sanitario de la publicidad de productos de interés sanitario' in force (Decreto N° 36868 S, cited on the Mini…
Prohibited advertising/sale of certain self-tests
Personal use IVDs for detecting HIV, HTLV, hepatitis B/C/D or other sexually transmitted agents, or detecting an infectious agent in cerebrospinal fluid or blood, are not authorized by the…
2 source-linked facts
Checked 2026-08-25
Open details →
D25

Submission communications & appeal

Verified
RegĂ­strelo electronic-domicile notifications and deadline computation
Users of the Regístrelo portal must designate an e mail address as their permanent electronic domicile for receiving notifications on proceedings managed in the system (Art. 14). A notifica…
Registration decisions due within fixed clocks from receipt — approve and issue, or reject
For EMB registration the Ministry has up to two months (odontología devices) or four months (microbiología and medicina devices) from receipt of the application to approve it and issue the…
2 source-linked facts
Checked 2026-08-28
Open details →

Government fees

Full fee schedule (4 lines) →

MOH registration fees in USD · reviewed 2026-08-25

Fee lineAmountProvenance
MD Registration - Class IUSD 0Verified
MD Registration - Class II$25Verified
MD Registration - Class III$50Verified
MD Registration - Class IV$50Verified

Registration timeline

Full registration timeline →

Ministry of Health of Costa Rica (MINSA) review clocks and planning ranges · 4-class (1, 2, 3, 4) — Decree 34554-S classification

Class / pathwayReview clockPlanning totalProvenance
Class 1(MINSA registration)2-4 months3-6 monthsVerified
Class 2(MINSA registration)2-4 months3-6 monthsVerified
Class 3(MINSA registration)2-4 months4-7 monthsVerified
Class 4(MINSA registration)2-4 months5-8 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(2-4 months)
  5. 5Registration Approval(1-2 weeks)

Key regulations

All 3 Costa Rica regulations →

Official Ministry of Health rules and guidance · 3 of 3 documents linked to official sources

Decreto 43902-S / RTCR 505:2022Biomedical Equipment Classification, Registration, Import, Labeling and Vigilance
GeneralVerified
Decreto 43789-SMedical Device Registration Renewal by Notification
RegistrationVerified
ResoluciĂłn MS-DM-4164-2025Admissibility Procedure for Medical Device Registration Applications
RegistrationVerified
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