ORBIS Compliance

Invima Updates Audit and Certification Request Format

Published /Colombia

Invima Updates Audit and Certification Request Format

The National Institute for Food and Drug Surveillance (Invima) has announced a revision to the format for requesting audit and certification procedures in order to streamline and enhance efficiency. Effective immediately, users are required to use the new format (ASS-AYC-FM33) when submitting requests for procedures including audits, visits, certifications, and certificates.

This update introduces specific formats tailored to each Missionary Technical Directorate, focusing on products and establishments such as medical devices and medications. By standardizing these formats, Invima aims to optimize the management of requests and ensure clarity and consistency in the processing of audit and certification applications.

Stakeholders and users are encouraged to adhere to the updated format to facilitate smoother interactions with Invima and expedite the handling of audit and certification requests. These changes underscore Invima's commitment to improving regulatory processes and maintaining rigorous standards in overseeing food, drug, and medical device safety in Colombia.

Regulatory Impact

  • Top Priority: Yes
  • Type of Certificate: Yes
  • Spectrum Bands: No
  • Import Changes HS Codes: No
  • Standard Changes: No
  • Product Changes: Yes
  • Label Changes: No

Link to Source - https://www.invima.gov.co/sala-de-prensa/comunicados/invima-cambia-el-formato-para-la-solicitud-de-tramites-de-auditorias-y-certificaciones

Regulatory Impact

Impact TypeStatus
Top Priority
Type Certificate
Spectrum Bands
Import Changes (HS Codes)
Standard Changes
Product Changes
Label Changes

Colombia Quick Facts

Regulatory AgencyComisión de Regulación de Comunicaciones (CRC)
Certification TypeMandatory
License ValidityIndefinite
Application LanguageSpanish
Legal License HolderNot required
In-country Testing RequirementNo testing required

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