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Ministry of Health Decreto

Decreto 43902-S / RTCR 505:2022

Biomedical Equipment Classification, Registration, Import, Labeling and Vigilance
Costa RicaMinistry of HealthGeneralEffective September 10, 2023
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What this code is

Decreto 43902-S / RTCR 505:2022 is the official MINSA identifier for “Biomedical Equipment Classification, Registration, Import, Labeling and Vigilance”. Decreto 43902-S / RTCR 505:2022 is the official identifier MINSA uses for this instrument.

Instrument
Decreto
Full name
Decreto 43902-S / RTCR 505:2022
Category
General
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Authority source
Spanish
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11 articles · 1 language version
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Dates
Published
November 30, 2022
Effective
September 10, 2023
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

Spanish full text11 articles · Spanish — SINALEVI full text (Decreto 43902-S arts. 1-7 and transitorios I-IV, RTCR 505:2022 clauses 1-25, annexes A-B)Read HTML →
About this regulation

Biomedical Equipment Classification, Registration, Import, Labeling and Vigilance

Core Costa Rican technical regulation covering medical device classification, registration, importation, labeling, advertising, vigilance, and market control, including medical software and mobile applications. Ingested from the PGR SINALEVI full-text service as corpus text: Decreto 43902-S articles 1-7 and transitorios I-IV (current through the Decreto 44431 reform of 11 April 2024), the RTCR 505:2022 body as clauses 1-25 under Disposiciones Generales, and normative annexes A (classification rules) and B (equivalence procedure); Spanish is the controlling text.

Decreto 43902-S / RTCR 505:2022 is the official identifier MINSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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