Country guide: Colombia
Cleanroom contractor in Colombia: rules for buyers
In Colombia INVIMA certifies the owner's good manufacturing practices, not the contractor, under Decree 335 of 2022 and the technical resolutions it cites. Hospitals enable their services under Resolution 3100 of 2019, which later resolutions changed.
By ZY Cleanroom · Updated · Sources at the end of the page
Which rules apply to your facility
Decree 335 of 2022 sets the procedure for certificates of good compounding, laboratory and manufacturing practices before INVIMA. It was signed on 8 March 2022 and took effect on 30 June 2022 (Decree 335 of 2022).
It points to technical requirements in nine resolutions, including Resolution 1160 of 2016 for medicines, or the rules that replace them (Decree 335 of 2022).
Resolution 3100 of 2019 was changed by Resolution 544 of 2023, Resolution 465 of 2025 and Resolution 914 of 2025. Since the 465 change, a provider must register at least one site with physical infrastructure and one enabled service (INVIMA normograma, checked 31 October 2026).
NSR-10, adopted by Decree 926 of 2010 and amended since, covers seismic design. It has a clause on the designer of non-structural elements, corrected by Decree 92 of 2011 (CRA normograma; Camacol, checked 31 October 2026).
| Facility | Rule |
|---|---|
| Medicine manufacturer | Decree 335 of 2022 and Resolution 1160 of 2016 |
| Hospital or clinic | Resolution 3100 of 2019, enablement of health services |
| Seismic design | NSR-10, Decree 926 of 2010 |
Who builds cleanrooms here
Decree 335 names compounding, laboratory and manufacturing establishments. Hospitals and clinics fall under Resolution 3100. Buyers search for cuartos limpios and salas limpias for all of them.
What to send for a first scope
Send the room list with the ISO 14644-1 class and occupancy state for each room. Add floor plans and ceiling heights. State whether the owner needs an INVIMA certificate or a health service enablement. Say whether the rooms are sterile or non-sterile.
Send your room list to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel factory in Tianjin, China, to have a first scope prepared. Certification and testing can be arranged per project.
Who does the site work
Site work is delivered with a licensed local contractor: yours, or one named in the contract. ZY supplies the design, panels, doors and numbered drawings.
Questions
Common questions
Which decree sets the procedure for good practice certificates in Colombia?
Decree 335 of 2022, signed on 8 March 2022, in effect from 30 June 2022 (Decree 335 of 2022).
Does INVIMA approve the contractor?
No. INVIMA certifies the owner's establishment. The owner chooses the contractor.
What is Resolution 3100 of 2019?
The rule that enables health service providers. Resolutions 544 of 2023, 465 of 2025 and 914 of 2025 changed it (INVIMA normograma, checked 31 October 2026).
Which seismic code applies to Colombian buildings?
NSR-10, adopted by Decree 926 of 2010 and amended later (CRA normograma, checked 31 October 2026).
Related guides
- How to audit a cleanroom panel factory, on site or by video
- How long does it take to build a cleanroom?
- Cleanroom cost per m²: published ranges by ISO class
- The Cleanroom Project Lifecycle
- Turnkey cleanroom contractor
- Room list builder
Sources
- Ministry of Health and Social Protection, Decree 335 of 8 March 2022, certificates of good practices before INVIMA
- INVIMA normograma, Resolution 3100 of 2019, compilation (checked 31 October 2026)
- Ministry of Health and Social Protection, Resolution 465 of 2025
- CRA normograma, Decree 926 of 2010, NSR-10 (checked 31 October 2026)
- Camacol, technical annex to Decree 92 of 2011, NSR-10 corrections (checked 31 October 2026)
Project enquiry
Send what you have
A room list, a floor plan or only the floor area is enough to start. After you submit, send drawings by email or WhatsApp.
We reply by email within one working day. We can sign an NDA before you send drawings.
WhatsApp +44 7962 561184 is our UK number for export enquiries. The factory is in Tianjin, China.
Email: [email protected]
WhatsApp: +44 7962 561184