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Ministry of Public Health Decreto

Decreto N° 428/022 (Res. GMC N° 25/21)

MERCOSUR Technical Regulation on Medical Device Registration
UruguayMinisterio de Salud PúblicaGeneralEffective January 20, 2023
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What this code is

Decreto N° 428/022 (Res. GMC N° 25/21) is the official MSP identifier for “MERCOSUR Technical Regulation on Medical Device Registration”. Decreto N° 428/022 (Res. GMC N° 25/21) is the official identifier MSP uses for this instrument.

Instrument
Decreto
Full name
Decreto N° 428/022 (Res. GMC N° 25/21)
Category
General
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Authority source
Spanish
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9 articles · 1 language version
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Dates
Published
January 20, 2023
Effective
January 20, 2023
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Spanish full text9 articles · Spanish — IMPO official text (decree arts. 1-4, Res. GMC N° 25/21 arts. 1-5, RTM Partes 1-5 and Apéndices I-V with the 22 classification rules)Read HTML →
About this regulation

MERCOSUR Technical Regulation on Medical Device Registration

Uruguay's current medical device framework: Decreto N° 428/022 internalises MERCOSUR Res. GMC N° 25/21 as an integral annex and derogates Decreto N° 7/001 (Res. GMC 40/00). Ingested from IMPO as corpus text: decree articles 1-4, the GMC resolution articles 1-5, RTM Partes 1-5 (scope, risk classes I-IV, registration procedure, conformity of information, administrative sanctions) and Apéndices I-V, including the 22 classification rules of Apéndice II as individually citeable passages. Spanish is the controlling text.

Decreto N° 428/022 (Res. GMC N° 25/21) is the official identifier MSP uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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