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ARCSA IE-B.3.2.1-DM-01,

IE-B.3.2.1-DM-01, Version 6.0

Medical-device registration, renewal and modification requirements, including Annex4
EcuadorARCSARegistrationCurrentness under review
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Document status

Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.

What this code is

IE-B.3.2.1-DM-01, Version 6.0 is the official ARCSA identifier for “Medical-device registration, renewal and modification requirements, including Annex4”. IE-B.3.2.1-DM-01, Version 6.0 is the official identifier ARCSA uses for this instrument.

Instrument
IE-B.3.2.1-DM-01,
Full name
IE-B.3.2.1-DM-01, Version 6.0
Category
Registration
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Source publication
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Dates
Published
February 2024
Effective
—
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About this regulation

Medical-device registration, renewal and modification requirements, including Annex4

Full47-page official instruction including all four annexes. Annex4 physicalpp34–47 (printed1–14) specifies brand/name/address/model, product-owner and applicant changes. Office-only address events must be mapped to actual legal role before selecting notification vs modification.

IE-B.3.2.1-DM-01, Version 6.0 is the official identifier ARCSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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