CROSS-STANDARD public interest · PPE / respirator (mask)
China-to-Colombia PPE Respirator (KN95 / FFP Mask) Compliance Gap Matrix
AI-compiled from official public sources — cross-checked by multiple AI models, not human-verified. Informational only; see disclaimer. Public-interest, source-linked comparison of Chinese PPE respirator (KN95 / GB 2626 and GB 19083) documentation against Colombian market-access expectations: NTC respirator standards adopted by ICONTEC, the occupational health and safety (SG-SST) framework under Decreto 1072/2015 administered by the Ministry of Labour, the in-country importer's obligations, and INVIMA health registration for medical/surgical masks. Colombia does not operate an EU-style horizontal PPE regulation; the RETIE/RETILAP/RETIQ technical regulations cover electrical, lighting and energy-labelling products rather than respiratory PPE, so respirator conformity runs through occupational, voluntary-standard and (for medical masks) sanitary channels.
Dataset 2026-06-11
Last verified 2026-06-15
6 rows
GAP MATRIX
Compliance Gap Matrix
| Compliance item | Common China baseline | Colombia (RETIE/RETILAP) | Gap / action | Source + verification date |
|---|---|---|---|---|
| Conformity Route for Filtering Respirators — Occupational (SG-SST) + Voluntary NTC/ONAC vs. China CCC | For industrial respiratory protection, China applies the compulsory product certification (CCC / 3C) scheme to GB 2626-2019 (KN95) respirators, administered by SAMR/CNCA with type testing by a CNAS-accredited laboratory plus factory inspection. For medical-protective masks, GB 19083-2010 products are regulated by NMPA as Class II medical devices. China's route is therefore a single mandatory national scheme per product class (CCC for industrial, NMPA registration for medical). Neither the CCC certificate nor the NMPA registration is automatically recognised by Colombian authorities, the SG-SST employer due-diligence process, or ONAC-accredited certification bodies.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (CCC mandatory certification, SAMR/CNCA) GB 19083-2010 — Technical requirements for medical protective mask (NMPA Class II medical device registration) |
Colombia does NOT have an EU-style horizontal PPE regulation that subjects filtering facepiece respirators to a single mandatory third-party conformity assessment. Instead, two parallel channels govern market access: (1) OCCUPATIONAL CHANNEL: Under the Sistema de Gestion de la Seguridad y Salud en el Trabajo (SG-SST), established by Decreto 1072/2015 (Libro 2, Parte 2, Titulo 4, Capitulo 6) and operationalised by Resolucion 0312/2019, the employer is legally obliged to identify respiratory hazards and provide workers with suitable, certified respiratory protective equipment. The respirator must demonstrate fitness for purpose, typically by certification to a recognised standard (NTC adopted by ICONTEC, or international references such as EN 149 / NIOSH 42 CFR Part 84). (2) VOLUNTARY/CONTRACTUAL CONFORMITY: Conformity is commonly evidenced by a certificate of conformity from an ONAC-accredited certification body against the relevant NTC standard, or by accepted foreign certification, rather than by a compulsory technical regulation. The technical regulations RETIE (electrical), RETILAP (lighting) and RETIQ (energy labelling) do NOT apply to respirators. An in-country importer of record is required to place the product on the Colombian market and is the responsible party for documentation and customs.Decreto 1072 de 2015 — Decreto Unico Reglamentario del Sector Trabajo (SG-SST, Libro 2 Parte 2 Titulo 4 Capitulo 6) — employer obligation to provide certified PPE Resolucion 0312 de 2019 — Estandares Minimos del SG-SST (Ministerio del Trabajo) NTC respirator standards adopted by ICONTEC (national adoptions tracking ISO/EN/NIOSH references) ONAC — Organismo Nacional de Acreditacion de Colombia (accreditation of certification/inspection bodies) |
Exporters must reorient from a single CCC certificate to Colombia's split occupational-plus-voluntary model: (1) Identify the correct channel — industrial respirator (SG-SST/NTC route) vs. medical/surgical mask (INVIMA route, see labelling/scope rows); (2) Appoint an in-country importer of record who holds the documentation and is the responsible party for customs and any SIC inquiry; (3) Obtain a certificate of conformity from an ONAC-accredited body against the applicable NTC respirator standard, OR provide accepted foreign certification (e.g., EN 149 or NIOSH) that the importer/end-employer will accept as fitness-for-purpose evidence under SG-SST; (4) Note there is NO mandatory RETIE/RETILAP/RETIQ pathway for respirators — do not attempt to certify a mask under those electrical/lighting/energy regulations; (5) The Chinese CCC certificate alone does not discharge the employer's SG-SST due-diligence duty, so a Colombian-recognised conformity document or test report is needed.[INFORMATIONAL] Colombia regulates filtering respirators through the SG-SST occupational framework (Decreto 1072/2015) plus voluntary/contractual conformity to NTC standards via ONAC-accredited bodies, not through an EU-style mandatory PPE regulation and not through RETIE/RETILAP/RETIQ. Chinese CCC and NMPA approvals are not automatically recognised. Exporters need an in-country importer of record and a Colombian-acceptable conformity document (NTC certification or accepted foreign certification such as EN 149/NIOSH) before placing industrial respirators on the market; medical/surgical masks follow the separate INVIMA route. | Gobierno de Colombia — Funcion Publica (Decreto 1072 de 2015)2026-06-15 · reference |
| Product Labelling and Instructions — Spanish Language, NTC/INVIMA References, Importer Details vs. China GB 2626 Marking | GB 2626-2019 Clause 7 specifies Chinese marking for non-powered particle respirators: manufacturer name/trademark, product name, model, standard number (GB 2626-2019), performance class (KN90/KN95), NR or R designation, plus packaging information (manufacturer address/contact, production date and shelf life, lot number, storage conditions, Chinese-language instructions), with the CCC mark on product and packaging. Medical masks under GB 19083 / YY 0469 carry the NMPA registration number and Chinese labelling. Key differences from Colombia: Chinese labelling is in Chinese only (Colombia requires Spanish); the CCC mark and GB standard number replace any Colombian reference; no in-country importer-of-record details and no INVIMA number are present.GB 2626-2019 — Clause 7 (Marking and packaging requirements) China CCC (3C) mark on product and packaging; NMPA registration number for medical masks (GB 19083 / YY 0469) |
Labelling for masks placed on the Colombian market must be in SPANISH and must match the chosen regulatory route. (A) INDUSTRIAL RESPIRATOR (SG-SST/NTC): The product and packaging should carry the manufacturer name/trademark, model, the standard the respirator is certified against (the relevant NTC standard, or the accepted foreign standard such as EN 149 FFP class or NIOSH N95), performance class, single-use (NR) or reusable (R) indication where applicable, lot/batch and shelf-life information, storage conditions, and Spanish-language instructions for use covering donning/doffing, fit-check, limitations, and storage. The in-country importer's name and address should appear so the responsible party is identifiable to SIC. (B) MEDICAL / SURGICAL MASK (INVIMA): Labelling must additionally show the INVIMA sanitary registration number, intended medical use, and the responsible Colombian registrant/importer, with instructions in Spanish per the device regime. Consumer-protection and labelling rules are enforced by SIC; medical labelling by INVIMA. Colombia does not require an EU-style CE mark or a Notified Body number on the device.Spanish-language labelling and instructions for use (consumer-protection / SIC requirements) Standard reference on label: relevant NTC respirator standard, or accepted foreign standard (EN 149 FFP / NIOSH N95) for industrial respirators INVIMA sanitary registration number on labelling for medical/surgical masks (Decreto 4725/2005) Importer/registrant identity on label (responsible party for SIC/INVIMA) |
Typical labelling gaps for Chinese exporters to Colombia: (1) LANGUAGE: Chinese-only labelling and instructions are not acceptable — full Spanish translation of the label and instructions for use is required. (2) STANDARD CITATION: For industrial respirators, cite the relevant NTC standard (or the accepted foreign standard the certificate is based on, e.g., EN 149 FFP2 or NIOSH N95) — a bare GB 2626-2019 citation does not establish Colombian conformity. (3) IMPORTER DETAILS: The in-country importer of record's name and address must be identifiable on the packaging so SIC can reach the responsible party. (4) MEDICAL MASKS: The INVIMA registration number and intended medical use must appear; the NMPA number is not accepted and a medical claim without INVIMA registration is non-compliant. (5) MARK HANDLING: Do not rely on the CCC mark as a Colombian conformity mark; there is no CE-style mark to add for respirators. (6) NO 'KN95 = FFP2/N95' SHORTCUT: Do not label the product as meeting an NTC/EN/NIOSH grade unless it is actually certified to that grade — the classes use different test methods and mislabelling can trigger SIC consumer-protection action. (7) RETIE/RETILAP/RETIQ marks are irrelevant and must not be applied to masks.[INFORMATIONAL] Masks for Colombia require Spanish-language labelling and instructions plus an identifiable in-country importer of record. Industrial respirators should cite the standard they are certified against (relevant NTC, or accepted EN 149/NIOSH grade), while medical/surgical masks must display the INVIMA sanitary registration number. Chinese-only labelling, the CCC mark, NMPA numbers, and bare GB 2626 citations are not sufficient, and RETIE/RETILAP/RETIQ marks do not apply to masks. Labelling a product to an NTC/EN/NIOSH grade it is not certified to may trigger SIC consumer-protection action. | Superintendencia de Industria y Comercio (SIC) — Colombia2026-06-15 · reference |
| Conformity Mark, Certificate of Conformity, and In-Country Importer/Registrant vs. China CCC | In China, conformity for industrial particle respirators is demonstrated by the CCC (3C) mark, affixed after certification by a CNCA-authorised body for GB 2626 products. For medical-protective masks, NMPA registration (with a registration certificate number shown on labelling) is the controlling approval. China does not require an in-country importer of record for domestic-market conformity in the same sense, since the manufacturer/certificate holder is domestic. The CCC mark and NMPA registration documents are not accepted by Colombian authorities (SIC/INVIMA) or by ONAC-accredited bodies as evidence of Colombian conformity.China CCC (3C) certification — CNCA mandatory certification system for GB 2626-2019 industrial respirators NMPA medical device registration — for GB 19083 / YY 0469 medical masks (registration number on labelling) |
Colombia does not have a single mandatory conformity mark for filtering respirators equivalent to the EU CE mark, because respirators are not covered by a horizontal PPE regulation or by RETIE/RETILAP/RETIQ. Instead the practical market-access elements are: (1) CERTIFICATE OF CONFORMITY: For an industrial respirator, a certificate of conformity issued by an ONAC-accredited certification body against the relevant NTC standard (or an accepted foreign certificate such as EN 149/NIOSH) evidences fitness for purpose under the SG-SST employer duty. There is no compulsory product mark to affix for respirators, but the certificate and test report must be available to the importer, the end-employer, and to SIC on request. (2) IN-COUNTRY IMPORTER OF RECORD: A Colombian importer/registrant must be the responsible party for placing the product on the market, holding documentation, and answering to SIC (industrial) or INVIMA (medical). (3) For MEDICAL masks, the relevant 'mark' is effectively the INVIMA registration number/authorisation, which must be reflected on labelling. SIC (Superintendencia de Industria y Comercio) enforces consumer-protection, metrology and conformity matters and can require the certificate of conformity at the point of surveillance.ONAC-accredited certificate of conformity against the relevant NTC respirator standard (industrial route) Decreto 1072 de 2015 — SG-SST (importer/employer must hold fitness-for-purpose evidence) INVIMA registration number/authorisation on labelling (medical mask route, Decreto 4725/2005) Superintendencia de Industria y Comercio (SIC) — market surveillance / consumer protection enforcement |
Exporters must replace the CCC/NMPA paperwork with Colombia-recognised evidence and a local responsible party: (1) NO CE-STYLE MARK TO AFFIX for respirators — instead hold an ONAC-accredited certificate of conformity to the relevant NTC standard, or an accepted foreign certificate (EN 149/NIOSH), available to the importer and SIC; (2) APPOINT AN IN-COUNTRY IMPORTER OF RECORD who is the responsible party for customs and surveillance — Chinese manufacturers commonly lack this and must arrange it before first shipment; (3) For MEDICAL masks, obtain an INVIMA registration and show the registration number on labelling — the NMPA number is not accepted; (4) Do NOT present a CCC mark as a Colombian conformity mark; remove or do not rely on it for market-access purposes; (5) Do NOT seek RETIE/RETILAP/RETIQ certificates for a respirator — these technical regulations do not cover masks and a body cannot certify a mask under them.[INFORMATIONAL] Colombia has no CE-style compulsory mark for filtering respirators (they are outside RETIE/RETILAP/RETIQ). The practical requirements are an in-country importer of record plus an ONAC-accredited certificate of conformity to the relevant NTC standard (or an accepted foreign certificate such as EN 149/NIOSH) for industrial respirators, and an INVIMA registration number on labelling for medical masks. Chinese CCC marks and NMPA registrations are not accepted by SIC/INVIMA or ONAC bodies and must be replaced with Colombia-recognised documentation. | Superintendencia de Industria y Comercio (SIC) — Colombia2026-06-15 · reference |
| Industrial Filtering Respirator Performance — NTC Respirator Standards (ICONTEC) vs. GB 2626 KN95 | China's primary standard for non-powered air-purifying particle respirators is GB 2626-2019 (Respiratory protective equipment — Non-powered air-purifying particle respirator), with classes KN90 and KN95. It is a mandatory national standard (GB, not GB/T) enforced by SAMR. KN95 requires >=95% filtration efficiency against NaCl particles at 85 L/min. GB 2626 uses NaCl aerosol (and oil-based KP classes use paraffin oil), specifies inhalation/exhalation resistance and total inward leakage, but its test detail differs from EN 149 (which mandates both NaCl and paraffin oil for the same FFP class and a simulated workplace practical performance test) and from NIOSH N95 (NaCl only at 85 L/min, US protocol). A Chinese CNAS-accredited GB 2626 test report is not automatically recognised as conformity to the NTC standard chosen by a Colombian employer or ONAC-accredited body.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (mandatory national standard, SAMR) GB/T 32610-2016 — Technical specification of daily protective mask (voluntary, for general public — not industrial PPE) |
For industrial respiratory protection in Colombia, the performance benchmark is the relevant NTC (Norma Tecnica Colombiana) respirator standard adopted by ICONTEC, which Colombia generally aligns with international references (ISO respiratory protective device standards, EN 149 filtering half masks, or NIOSH 42 CFR Part 84 N95). Under the SG-SST framework (Decreto 1072/2015), the employer must select a respirator whose performance is demonstrated against such a standard for the identified hazard. Typical performance elements assessed are: filtration/particle penetration efficiency, total inward leakage or fit, breathing (inhalation/exhalation) resistance, and (for some references) practical performance. Because Colombia has no single mandatory technical regulation forcing one method, conformity is shown either by an ONAC-accredited certification to the chosen NTC standard or by an accepted foreign certificate (e.g., a valid EN 149 type-examination or NIOSH approval) that the importer and end-employer treat as fitness-for-purpose evidence. Grid/voltage facts (110/220 V, 60 Hz) are irrelevant to non-powered respirators and only matter for any powered air-purifying respirator (PAPR) accessories.NTC respirator standards adopted by ICONTEC (national adoptions tracking ISO respiratory protective device / EN 149 / NIOSH 42 CFR Part 84 references) Decreto 1072 de 2015 — SG-SST (employer must provide respirator suited to the identified hazard) Accepted foreign references in practice: EN 149:2001+A1:2009 (FFP) and NIOSH 42 CFR Part 84 (N95) |
Exporters should obtain or align a respirator test/certificate to the NTC respirator standard accepted in Colombia, or supply an accepted foreign certificate the importer/employer will rely on: (1) A GB 2626 (KN95) report alone is not, by default, accepted as NTC conformity; either certify to the relevant NTC standard via an ONAC-accredited body, or present a valid EN 149 type-examination or NIOSH approval that the Colombian buyer accepts under SG-SST; (2) Where the NTC standard tracks EN 149, the GB 2626 test gaps (paraffin oil aerosol and simulated workplace performance test absent from GB 2626) must be closed; (3) Confirm with the importer which standard their SG-SST programme references for the specific hazard so the right grade (e.g., FFP2/N95-equivalent) is supplied; (4) There is no mandatory RETIE/RETILAP/RETIQ test for respirators — do not seek those certificates for a mask.[INFORMATIONAL] Industrial respirators for Colombia should be certified or demonstrated against the relevant NTC respirator standard adopted by ICONTEC (tracking ISO/EN 149/NIOSH references), with conformity shown via an ONAC-accredited body or an accepted foreign certificate the importer/employer will rely on under SG-SST. A Chinese GB 2626 (KN95) report is not automatically equivalent — where the NTC standard tracks EN 149, the paraffin-oil and simulated-workplace-performance gaps must be addressed. No RETIE/RETILAP/RETIQ test applies to masks. | ICONTEC — Instituto Colombiano de Normas Tecnicas y Certificacion2026-06-15 · reference |
| Medical / Surgical Mask Safety — INVIMA Medical-Device Route vs. China GB 19083 / YY 0469 | China's medical-mask standards are GB 19083-2010 (medical protective mask, >=95% NaCl filtration, plus surface moisture resistance and pressure differential) and YY 0469-2011 (medical surgical mask, bacterial filtration efficiency >=95%, particle filtration and synthetic-blood penetration resistance). Both are regulated by NMPA as Class II medical devices in China. They are domestic medical-device approvals and are NOT automatically recognised by INVIMA: a Colombian sanitary registration dossier is required, with performance demonstrated against the Colombian-accepted reference (NTC adoption of ISO/EN mask standards or EN 14683-type evidence), labelling in Spanish, and a responsible registrant/importer in Colombia.GB 19083-2010 — Technical requirements for medical protective mask (NMPA Class II) YY 0469-2011 — Medical surgical mask — Technical requirements (NMPA Class II) |
In Colombia, masks intended for medical, surgical or infection-control use are medical devices regulated by INVIMA, not occupational PPE. They require sanitary registration (registro sanitario) or the applicable marketing authorisation under the medical-device regime (Decreto 4725/2005 and INVIMA resolutions), with the dossier addressing the device's performance (e.g., bacterial filtration efficiency, breathability/pressure differential, fluid resistance for surgical masks; particle filtration and fit for medical respirators), risk classification, labelling, and a responsible importer/registrant in Colombia. Performance is typically evaluated against recognised references (the NTC adoption of ISO/EN device-mask standards, or international equivalents such as EN 14683 for surgical masks). Colombia does not have an EU-style horizontal PPE regulation, and the medical-device sanitary route is entirely separate from the SG-SST/NTC occupational respirator route described in ppeco-safety-001.Decreto 4725 de 2005 — Regimen de registros sanitarios, permisos de comercializacion y vigilancia de dispositivos medicos (INVIMA) INVIMA sanitary registration / marketing authorisation for medical masks and medical respirators NTC adoptions of ISO/EN medical-mask standards; international reference EN 14683 (surgical masks) commonly used for performance evidence |
A China-approved medical mask cannot be sold in Colombia on the strength of its NMPA approval alone: (1) INVIMA SANITARY REGISTRATION: Obtain a registro sanitario / marketing authorisation under Decreto 4725/2005 before import or sale; the GB 19083 / YY 0469 NMPA approval is not a substitute; (2) RESPONSIBLE REGISTRANT/IMPORTER: A Colombian legal entity must hold the registration and act as responsible party; (3) PERFORMANCE EVIDENCE: Provide test evidence against the Colombian-accepted reference (e.g., the NTC adoption or EN 14683 for surgical masks; particle filtration/fit data for medical respirators); (4) SPANISH LABELLING: Device labelling, intended use, and instructions must be in Spanish per the device regime; (5) DO NOT route via SG-SST/NTC industrial conformity for a medical-claimed mask — that occupational route does not authorise sale of a medical device; (6) RETIE/RETILAP/RETIQ are irrelevant to medical masks.[INFORMATIONAL] Medical and surgical masks for Colombia are medical devices requiring INVIMA sanitary registration under Decreto 4725/2005, held by a responsible Colombian registrant, with performance evidence against the Colombian-accepted reference and Spanish labelling. Chinese GB 19083 / YY 0469 NMPA approvals are not automatically recognised and do not substitute for INVIMA registration. This is a separate route from the SG-SST/NTC industrial respirator path; RETIE/RETILAP/RETIQ do not apply. | INVIMA — Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Colombia)2026-06-15 · reference |
| CRITICAL BOUNDARY: Industrial Respirator (SG-SST/NTC) vs. Medical/Surgical Mask (INVIMA) — Which Colombian Route Applies? | China uses a three-track classification system that partially maps to Colombia's split: (1) INDUSTRIAL / NON-MEDICAL: GB 2626-2019 (KN90/KN95) particle respirators for occupational use, mandatory CCC, administered by SAMR — corresponds to Colombia's SG-SST/NTC industrial route; (2) MEDICAL-PROTECTIVE: GB 19083-2010 (>=95% filtration, medical-grade) for highly infectious environments, NMPA Class II medical device — corresponds to Colombia's INVIMA medical-device route; (3) SURGICAL MASK: YY 0469-2011 (bacterial filtration efficiency >=95%), NMPA Class II medical device — also corresponds to the INVIMA medical route. As in the EU comparison, the mapping is not 1:1: KN95 (GB 2626) is a test-method-specific class that is not automatically equal to any NTC/EN/NIOSH grade, and China's medical masks (GB 19083 / YY 0469) fall on Colombia's INVIMA side, not the occupational PPE side.GB 2626-2019 — Non-powered air-purifying particle respirator (KN90/KN95) — SAMR/CCC (industrial) GB 19083-2010 — Technical requirements for medical protective mask — NMPA Class II (medical) YY 0469-2011 — Medical surgical mask — Technical requirements — NMPA Class II (medical) |
In Colombia the single most commercially important classification decision is whether the mask is an OCCUPATIONAL/INDUSTRIAL respirator or a MEDICAL/SURGICAL mask, because each triggers a different authority and route. (A) INDUSTRIAL RESPIRATOR (PROTECTS THE WEARER): Products intended to protect the worker against airborne particles/aerosols are handled through the Ministry of Labour's SG-SST framework (Decreto 1072/2015) — the employer must provide certified PPE, with conformity typically evidenced against an NTC respirator standard (ICONTEC adoptions tracking ISO/EN/NIOSH) via an ONAC-accredited certification body or accepted foreign certification. There is no EU-style horizontal PPE regulation and no RETIE/RETILAP/RETIQ coverage for respirators. (B) MEDICAL / SURGICAL MASK (PROTECTS PATIENT/ENVIRONMENT): Masks intended for medical, surgical or infection-control use are MEDICAL DEVICES regulated by INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos). They require INVIMA sanitary registration (registro sanitario / permiso de comercializacion) under the device framework (Decreto 4725/2005 and related resolutions), a completely separate route from the occupational PPE channel. (C) DUAL-CLAIM PRODUCTS: A mask marketed BOTH as worker particle protection AND as a medical/surgical device must satisfy BOTH the SG-SST/NTC expectations AND INVIMA registration — significantly more burdensome and a frequent compliance trap for exporters who copy multi-market labelling.Decreto 1072 de 2015 — SG-SST occupational framework (industrial respirator route; employer must supply certified PPE) NTC respirator standards adopted by ICONTEC (industrial respirator conformity reference, tracking ISO/EN/NIOSH) Decreto 4725 de 2005 — Regimen de registros sanitarios de dispositivos medicos (INVIMA) — medical/surgical mask route INVIMA — Instituto Nacional de Vigilancia de Medicamentos y Alimentos (sanitary registration authority for medical masks) |
The decisive question is what the product label and instructions claim: (1) If the product claims WEARER PROTECTION against particles/aerosols (worker/industrial safety): route via SG-SST (Decreto 1072/2015) with conformity against an NTC respirator standard through an ONAC-accredited body or accepted foreign certification; no INVIMA registration is needed for a purely industrial respirator. (2) If the product claims MEDICAL, SURGICAL or infection-control use: it is a medical device requiring INVIMA sanitary registration before import/sale — an entirely separate dossier and timeline. (3) If the product claims BOTH: both routes apply. COMMON EXPORT MISTAKE: Chinese manufacturers print 'medical' / 'surgical' / 'KN95 medical' language to widen the market; in Colombia that wording converts the mask into an INVIMA-regulated medical device and importing it as plain industrial PPE without INVIMA registration is non-compliant. Note also that RETIE/RETILAP/RETIQ are irrelevant to masks; presenting a respirator as needing those technical-regulation certificates is a misunderstanding of Colombian scope.[INFORMATIONAL — CRITICAL BOUNDARY] In Colombia an industrial respirator (protecting the wearer) runs through the SG-SST occupational framework with NTC/ONAC or accepted foreign conformity, while a medical/surgical mask (protecting patient/environment) is a medical device requiring INVIMA sanitary registration — a completely separate route. The two must not be mixed; dual-claim products need both. RETIE/RETILAP/RETIQ technical regulations do NOT apply to masks. Chinese KN95 (GB 2626) industrial respirators follow the SG-SST/NTC route, but adding 'medical'/'surgical' labelling pulls the product into INVIMA's medical-device regime and is the most common Colombia-bound compliance error. | INVIMA — Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Colombia)2026-06-15 · reference |
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- Gobierno de Colombia — Funcion Publica (Decreto 1072 de 2015) · accessed 2026-06-15 · reference · used in 1 rows
- Superintendencia de Industria y Comercio (SIC) — Colombia · accessed 2026-06-15 · reference · used in 2 rows
- ICONTEC — Instituto Colombiano de Normas Tecnicas y Certificacion · accessed 2026-06-15 · reference · used in 1 rows
- INVIMA — Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Colombia) · accessed 2026-06-15 · reference · used in 2 rows