ARCSA ARCSA-DE-2023-016-AKRGARCSA-DE-2023-016-AKRG
National Technovigilance System
EcuadorARCSAVigilanceEffective June 19, 2023
What this code is
ARCSA-DE-2023-016-AKRG is the official ARCSA identifier for “National Technovigilance System”. ARCSA-DE-2023-016-AKRG is the official identifier ARCSA uses for this instrument.
- Instrument
- ARCSA-DE-2023-016-AKRG
- Full name
- ARCSA-DE-2023-016-AKRG
- Category
- Vigilance
Source links
- Authority source
- Spanish
- Readable HTML
- 11 articles · 1 language version
Authority publication; confirm whether a later amendment or consolidated version applies.
Direct citations can link to an article, for example /data/regulations/ecuador/arcsa-2023-016.es.html#art-1.
Dates
- Published
- June 19, 2023
- Effective
- June 19, 2023
Readable full text
Open a language version
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.
About this regulation
National Technovigilance System
Substitute technical regulation for Ecuador’s National Technovigilance System. Replaces ARCSA-DE-003-2017-CFMR and sets adverse-event reporting and field-action duties.
ARCSA-DE-2023-016-AKRG is the official identifier ARCSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.