CROSS-STANDARD public interest · PPE / respirator (mask)
China-to-Vietnam PPE Respirator (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) documentation against Vietnam requirements under the TCVN voluntary standards and QCVN national technical regulations system, STAMEQ certification of conformity (CR mark), the MOLISA (Ministry of Labour, Invalids and Social Affairs) occupational-safety framework for industrial respiratory protection, the in-country importer obligation, and the boundary where medical masks fall under the Ministry of Health rather than the labour-safety route.
Dataset 2026-06-11
Last verified 2026-06-15
6 rows
GAP MATRIX
Compliance Gap Matrix
| Compliance item | Common China baseline | Vietnam (TCVN / QCVN) | Gap / action | Source + verification date |
|---|---|---|---|---|
| Conformity Assessment — TCVN/QCVN route, STAMEQ certification of conformity (CR mark) and MOLISA occupational-safety oversight | For industrial respiratory protection under GB 2626-2019 (KN95), China applies a compulsory certification (CCC) scheme administered by CNCA and third-party certification bodies (e.g., China Quality Certification Centre, CQC). The conformity assessment involves type testing by a CNAS-accredited laboratory followed by factory inspection. For medical-protective masks (GB 19083), NMPA registration is required as a medical device. Neither the CCC scheme nor the NMPA medical-device registration is automatically recognised as a Vietnamese certification of conformity under the QCVN regime; they are technical evidence that a STAMEQ-designated body may consider but cannot replace a Vietnamese conformity certificate or the CR mark.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (CCC mandatory certification under CNCA) GB 19083-2010 — Technical requirements for medical protective mask (NMPA medical-device registration) |
Vietnam separates voluntary standards (TCVN, Tieu chuan Viet Nam) from mandatory national technical regulations (QCVN, Quy chuan ky thuat quoc gia) under the Law on Standards and Technical Regulations No. 68/2006/QH11 and the Law on Product and Goods Quality No. 05/2007/QH12. STAMEQ (Directorate for Standards, Metrology and Quality) under the Ministry of Science and Technology administers the system and designates certification and testing bodies. Where a product falls under a QCVN, conformity must be demonstrated through certification of conformity (chung nhan hop quy) and/or declaration of conformity (cong bo hop quy) by a designated body, after which the CR conformity mark is applied. For respiratory protective equipment used in the workplace, MOLISA (Ministry of Labour, Invalids and Social Affairs) owns the occupational-safety and personal-protective-equipment regime (Law on Occupational Safety and Health No. 84/2015/QH13), which can require state-inspection/quality-control of imported PPE. The applicable technical basis is typically the TCVN respirator series (e.g., the TCVN 8197 family adopting EN 149 filtering half-mask requirements) referenced by the regulator.Law on Standards and Technical Regulations No. 68/2006/QH11 (TCVN voluntary standards vs QCVN mandatory national technical regulations) Law on Product and Goods Quality No. 05/2007/QH12 (certification of conformity / declaration of conformity, CR mark) Law on Occupational Safety and Health No. 84/2015/QH13 (MOLISA personal protective equipment regime) TCVN 8197 series — Respiratory protective devices — Filtering half masks to protect against particles (adopting EN 149) |
The conformity assessment must be re-established under the Vietnamese framework. Specific gaps: (1) determine whether the specific respirator falls under a mandatory QCVN or only voluntary TCVN, and obtain certification/declaration of conformity from a STAMEQ-designated body where required, then apply the CR mark; (2) Chinese CCC certificates and NMPA registrations do not substitute for a Vietnamese certification of conformity; (3) industrial respiratory PPE may be subject to MOLISA state quality-control/inspection on import under Law No. 84/2015/QH13; (4) testing should be against the TCVN/QCVN basis the regulator references (TCVN 8197 / EN 149 class requirements), which a Vietnamese designated lab or an accepted accredited lab can perform; (5) a Vietnamese importer of record must hold and present the conformity documentation; (6) the technical file (test reports, design data, instructions in Vietnamese) must be maintained for market-surveillance.[INFORMATIONAL] Conformity must be re-established under Vietnam's TCVN/QCVN system. Where a mandatory QCVN applies, a certification or declaration of conformity from a STAMEQ-designated body and the CR mark are required, and workplace respiratory PPE may face MOLISA state quality-control on import. Chinese CCC or NMPA certifications are technical evidence only and do not constitute Vietnamese conformity. Exporters should confirm the applicable QCVN/TCVN basis and engage a Vietnamese designated body through an in-country importer before placing products on the market. | STAMEQ — Directorate for Standards, Metrology and Quality (Ministry of Science and Technology, Vietnam)2026-06-15 · reference |
| Goods labelling and Vietnamese-language user information — origin, importer, and instructions for use | In China, GB 2626-2019 and the medical-device rules require manufacturer-supplied information and packaging marking in Chinese — product name, standard, filter class, manufacturer, model, production and expiry dates, storage conditions, and instructions for use (donning, fit-check, limitations). Medical-protective masks under GB 19083 carry the labelling required for an NMPA-registered medical device. The information is complete for the Chinese market but is provided in Chinese and references GB standards and the Chinese manufacturer/registrant, not a Vietnamese importer or Vietnamese-language instructions.GB 2626-2019 — Chinese-language manufacturer information, packaging marking, and instructions for use GB 19083-2010 — Chinese-language labelling for NMPA-registered medical-protective masks |
All goods circulating in Vietnam must carry a compliant label under Decree No. 43/2017/ND-CP on goods labelling (as amended by Decree No. 111/2021/ND-CP). For imported respirators the label must show, in Vietnamese, the product name, the name and address of the organisation/individual responsible for the goods (the importer of record in Vietnam) and the manufacturer, the country/place of origin, the quantity/specification, the date of manufacture and shelf life/expiry, storage and warning information, and instructions for use and safety. Imported goods may keep the original foreign label but must add a supplementary Vietnamese-language label (nhan phu) carrying the mandatory content before being supplied to consumers. For an industrial respirator, the instructions for use (donning, fit, protection class, limitations, shelf life) must be available in Vietnamese, and where a QCVN applies the CR mark and conformity reference appear in conjunction with the label.Decree No. 43/2017/ND-CP on labels of goods (amended by Decree No. 111/2021/ND-CP) — mandatory Vietnamese-language label content and supplementary label (nhan phu) for imported goods TCVN 8197 series / EN 149:2001+A1:2009 — information supplied by the manufacturer (instructions for use, limitations, shelf life) |
The labelling must be re-issued for Vietnam. Specific gaps: (1) a Vietnamese-language supplementary label (nhan phu) under Decree 43/2017/ND-CP must be added with product name, responsible importer name/address, manufacturer, origin, quantity/spec, manufacture date and shelf life, storage, warnings, and use instructions; (2) Chinese-only labelling and GB references are insufficient — the responsible party shown must be the Vietnamese importer of record; (3) instructions for use must be translated into Vietnamese (donning, fit, protection class, limitations); (4) where a QCVN applies, the CR mark and conformity reference must accompany the label; (5) for medical-claim masks, labelling additionally follows the Ministry of Health medical-device requirements under Decree 98/2021/ND-CP; (6) label content must match the conformity documentation to withstand market surveillance.[INFORMATIONAL] Imported respirators need a compliant Vietnamese-language label, in practice a supplementary label (nhan phu) under Decree 43/2017/ND-CP, naming the Vietnamese importer of record and carrying origin, shelf life, storage, warnings, and Vietnamese use instructions; Chinese-only labelling and GB references are insufficient. Where a QCVN applies the CR mark accompanies the label, and medical-claim masks additionally follow the Ministry of Health labelling rules. Exporters should prepare the Vietnamese label and translated instructions before distribution. | Government of Vietnam — Decree No. 43/2017/ND-CP on labels of goods (vanban.chinhphu.vn)2026-06-15 · reference |
| Product marking — CR conformity mark, protection-class marking, and standard reference on the respirator | GB 2626-2019 requires the respirator and/or packaging to be marked with the standard number, the filter class (e.g., KN95), the manufacturer name or trademark, the model, the production/expiry information, and storage conditions; industrial respirators in scope additionally carry the CCC mark once certified. Medical-protective masks under GB 19083 carry the registration information required for an NMPA-registered medical device. The Chinese KN-class and CCC marking is not the same as the Vietnamese CR mark or the FFP-class marking, and a CCC mark has no standing in Vietnam.GB 2626-2019 — marking of standard number, filter class (KN95), manufacturer, model, production/expiry, storage; CCC mark where certified GB 19083-2010 — marking for NMPA-registered medical-protective masks |
Where a respirator falls under a mandatory QCVN, the product (or its packaging where the item is too small) must bear the CR conformity mark (dau hop quy) after a STAMEQ-designated body has issued the certification/declaration of conformity, signalling that the goods meet the applicable national technical regulation. On the respirator itself, the TCVN/EN 149 basis expects durable marking of the manufacturer's identification, the standard reference and protection class (e.g., FFP2), the type/model, and, where relevant, the 'NR' (non-reusable, single-shift) or 'R' (reusable) and 'D' (dolomite clogging tested) designations, plus shelf-life/storage symbols. Marking must be legible and durable for the life of the product. Industrial PPE placed on the market through MOLISA's framework must be marked consistently with the conformity documentation held by the importer.Law on Product and Goods Quality No. 05/2007/QH12 — CR conformity mark (dau hop quy) for goods under a QCVN TCVN 8197 series / EN 149:2001+A1:2009 — marking of standard reference, protection class (FFP1/FFP2/FFP3), NR/R and D designations, manufacturer ID, shelf life |
The product marking must be converted to the Vietnamese scheme. Specific gaps: (1) the CCC mark and KN-class designation are not recognised in Vietnam — where a QCVN applies, the CR mark must be added after a STAMEQ-designated body certifies/declares conformity; (2) the protection-class marking should be the TCVN/EN 149 FFP class consistent with the accepted test report, not the KN class alone; (3) NR/R and D designations and the standard reference should follow the TCVN/EN 149 marking convention; (4) the marking must be durable and legible on the respirator (or packaging if the item is too small); (5) marking content must match the conformity certificate and the importer's documentation to avoid market-surveillance findings.[INFORMATIONAL] Chinese CCC and KN-class markings carry no standing in Vietnam. Where a mandatory QCVN applies, the CR conformity mark must be applied after a STAMEQ-designated body certifies or declares conformity, and the protection-class/standard marking should follow the TCVN/EN 149 FFP convention consistent with the accepted test report. Marking must be durable, legible, and aligned with the importer's conformity documentation. | STAMEQ — Directorate for Standards, Metrology and Quality (CR conformity mark guidance, Vietnam)2026-06-15 · reference |
| Filtration performance and protection class — TCVN/EN 149 FFP basis vs GB 2626 KN classes | GB 2626-2019 classifies non-powered air-purifying particle respirators into KN (against non-oily particles) and KP (against oily and non-oily particles) series, with filter efficiency grades KN90/KN95/KN100 and KP90/KP95/KP100. A KN95 must achieve at least 95% filtration against a sodium chloride aerosol. GB 2626 tests filter penetration, total inward leakage, breathing resistance, dead space (CO2), and other parameters. While KN95 and FFP2 are broadly comparable in headline filtration (about 94-95%), the test aerosols, leakage criteria, and pass/fail thresholds differ, so a GB 2626 KN class result is not numerically interchangeable with an EN 149 FFP class.GB 2626-2019 — KN90/KN95/KN100 and KP90/KP95/KP100 filter-efficiency classes; total inward leakage; breathing resistance; dead space | For industrial filtering half masks, Vietnam references the TCVN respirator series that adopts EN 149:2001+A1:2009, which defines three protection classes — FFP1, FFP2, FFP3 — by maximum total inward leakage and minimum filter penetration performance against both a sodium chloride and a paraffin oil aerosol. EN 149 also tests breathing resistance, clogging (for the optional 'R' reusable and 'D' dolomite-dust clogging designations), CO2 content of inhaled air, and practical performance. The protection class claimed on a respirator entering Vietnam as occupational PPE should be substantiated by testing to this TCVN/EN 149 basis, performed by a Vietnamese designated laboratory or an accredited laboratory whose report the STAMEQ-designated certification body accepts.TCVN 8197 series — Respiratory protective devices — Filtering half masks to protect against particles (adopting EN 149:2001+A1:2009; classes FFP1 / FFP2 / FFP3) EN 149:2001+A1:2009 — total inward leakage, filter penetration (NaCl and paraffin oil), breathing resistance, clogging, CO2 content |
The claimed protection class must be re-evidenced on the TCVN/EN 149 basis. Specific gaps: (1) a KN95 result does not automatically equal FFP2 — re-test or cross-map against EN 149 FFP class thresholds (NaCl plus paraffin oil aerosol, total inward leakage limits); (2) EN 149 requires the paraffin oil aerosol penetration test that GB 2626 KN-class testing does not include; (3) the FFP class marked on the respirator must match the TCVN/EN 149 test report accepted by the Vietnamese designated body; (4) breathing-resistance and CO2 results should be reported against EN 149 limits; (5) where the regulator references a specific TCVN/QCVN value, the test lab and method must align with it.[INFORMATIONAL] Vietnam references the TCVN/EN 149 FFP classes for industrial filtering half masks. A GB 2626 KN95 result is broadly comparable to FFP2 in headline filtration but is not numerically interchangeable because the test aerosols and leakage criteria differ, and EN 149 adds a paraffin-oil penetration test. Exporters should re-evidence the claimed FFP class on the TCVN/EN 149 basis through a laboratory the Vietnamese designated body accepts. | STAMEQ — Directorate for Standards, Metrology and Quality (TCVN catalogue, Vietnam)2026-06-15 · reference |
| Materials safety, breathability, and skin contact — basic health and ergonomics requirements for respirators | GB 2626-2019 also imposes non-filtration requirements: materials in contact with skin must not cause irritation or harm; the respirator must have no sharp edges; inhalation and exhalation resistance limits are specified; dead-space CO2 is controlled; flammability is tested (the material must not continue to burn beyond a set time after removal from a flame); and head harness and adjustment must provide a secure fit. For medical-protective masks, GB 19083-2010 adds skin-irritation, microbial, and synthetic-blood-penetration criteria appropriate to clinical use. The Chinese material-safety and ergonomic provisions are conceptually parallel to EN 149 but are documented under GB methods and thresholds.GB 2626-2019 — material harmlessness, sharp-edge, breathing resistance, dead-space CO2, flammability, head-harness fit GB 19083-2010 — skin irritation, microbial and synthetic-blood-penetration criteria for medical-protective masks |
Under the TCVN/EN 149 basis referenced by Vietnam, a filtering respirator must meet basic health, safety, and ergonomic requirements beyond pure filtration: materials in contact with the wearer's skin must not be known to be likely to cause irritation or any adverse effect on health; the device must not have sharp edges or projections likely to injure the wearer; breathing resistance (inhalation and exhalation) must stay within EN 149 limits so the device is usable without unacceptable effort; the carbon-dioxide content of the inhaled air (dead space) must be within limits; and straps and the nose-clip must allow a stable, adjustable fit. Flammability of materials is assessed so the device does not present an undue fire hazard. These ergonomic and material-safety properties are part of the same TCVN/EN 149 test report and, where MOLISA state quality-control applies, are reviewed as part of the workplace-PPE conformity.TCVN 8197 series / EN 149:2001+A1:2009 — material harmlessness, breathing resistance, CO2 dead space, flammability, strap and nose-clip fit Law on Occupational Safety and Health No. 84/2015/QH13 (MOLISA workplace-PPE health and ergonomics oversight) |
The material-safety and ergonomic evidence must be expressed against the TCVN/EN 149 clauses. Specific gaps: (1) GB material-harmlessness and flammability results should be mapped to or re-tested against the EN 149 limits the Vietnamese designated body recognises; (2) breathing-resistance and CO2 dead-space figures must be reported to EN 149 thresholds rather than GB thresholds; (3) any skin-contact or irritation data should be referenced to the TCVN basis; (4) where the product also carries a medical claim, the Ministry of Health medical-device route adds biocompatibility/skin-irritation documentation under Decree 98/2021/ND-CP; (5) under MOLISA state quality-control these ergonomic results may be re-checked on the import consignment.[INFORMATIONAL] Beyond filtration, a respirator entering Vietnam as industrial PPE must show material harmlessness, acceptable breathing resistance, controlled CO2 dead space, flammability safety, and a stable fit on the TCVN/EN 149 basis, under MOLISA oversight for workplace use. GB 2626 results are conceptually parallel but should be mapped or re-tested to EN 149 limits. Medical-claim products additionally require biocompatibility documentation under the Ministry of Health medical-device route. | MOLISA — Ministry of Labour, Invalids and Social Affairs (Vietnam, occupational-safety and PPE framework)2026-06-15 · reference |
| Scope and classification — industrial respiratory PPE (MOLISA/labour route) vs medical masks (Ministry of Health/medical-device route) | China draws the same intended-use boundary with different instruments. Industrial particulate respirators are covered by GB 2626-2019 (KN/KP classes) and treated as occupational PPE subject to CCC certification. Medical-protective masks are covered by GB 19083-2010 and regulated by NMPA as medical devices, while medical surgical masks follow YY 0469 and daily-protective masks follow GB/T 32610. The same physical mask in China can thus be governed by either the industrial-PPE standard (GB 2626) or the medical-device pathway (GB 19083 / YY 0469 under NMPA) depending on its declared use, mirroring the Vietnamese split.GB 2626-2019 — Non-powered air-purifying particle respirator (industrial PPE, CCC) GB 19083-2010 — Technical requirements for medical protective mask (NMPA medical device) YY 0469 — Surgical mask (NMPA medical device); GB/T 32610 — Daily protective mask |
Vietnam routes respiratory products by intended use. A filtering respirator marketed as occupational/industrial personal protective equipment is governed by the labour-safety regime under MOLISA (Law on Occupational Safety and Health No. 84/2015/QH13) and is assessed against the relevant TCVN/QCVN respirator basis (TCVN 8197 series adopting EN 149). By contrast, a mask presented for medical use (surgical masks, medical face masks, and medical-grade respiratory protection used in healthcare) is regulated as a medical device by the Ministry of Health under Decree No. 98/2021/ND-CP on the management of medical devices, requiring device classification, an applicable-standards declaration, and registration/declaration of applicable standards before circulation. The same physical mask can therefore fall under two entirely different competent authorities depending on the claim and intended use stated on the product and packaging, and dual-claim products must satisfy both routes.Law on Occupational Safety and Health No. 84/2015/QH13 (MOLISA personal protective equipment / industrial respirator route) Decree No. 98/2021/ND-CP on management of medical devices (Ministry of Health route for medical/surgical masks) TCVN 8197 series — Respiratory protective devices — Filtering half masks to protect against particles (industrial respirator basis adopting EN 149) |
The exporter must fix the Vietnamese classification before choosing a route. Specific gaps: (1) decide whether the product is marketed as industrial PPE (MOLISA/TCVN-QCVN route) or as a medical mask (Ministry of Health route under Decree 98/2021/ND-CP) — the marketing claim drives the authority; (2) a KN95 GB 2626 product positioned as industrial PPE follows the conformity/CR route, not the medical-device registration; (3) any medical/surgical claim moves the product to the Ministry of Health medical-device pathway, with device classification and declaration of applicable standards; (4) product naming, packaging, and instructions must be consistent with the chosen route to avoid mis-classification at customs and market surveillance; (5) dual-use marketing requires satisfying both regimes.[INFORMATIONAL] Intended use determines the regulator in Vietnam: an industrial filtering respirator follows the MOLISA / TCVN-QCVN PPE route, whereas any medical or surgical mask is a medical device under the Ministry of Health (Decree 98/2021/ND-CP). The wrong classification triggers a different authority, dossier, and timeline. Exporters should lock the classification first and align naming, packaging, and instructions to the chosen route before shipment. | Government of Vietnam — Decree No. 98/2021/ND-CP on management of medical devices (vanban.chinhphu.vn)2026-06-15 · reference |
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SOURCES
Official-source register.
- STAMEQ — Directorate for Standards, Metrology and Quality (Ministry of Science and Technology, Vietnam) · accessed 2026-06-15 · reference · used in 1 rows
- Government of Vietnam — Decree No. 43/2017/ND-CP on labels of goods (vanban.chinhphu.vn) · accessed 2026-06-15 · reference · used in 1 rows
- STAMEQ — Directorate for Standards, Metrology and Quality (CR conformity mark guidance, Vietnam) · accessed 2026-06-15 · reference · used in 1 rows
- STAMEQ — Directorate for Standards, Metrology and Quality (TCVN catalogue, Vietnam) · accessed 2026-06-15 · reference · used in 1 rows
- MOLISA — Ministry of Labour, Invalids and Social Affairs (Vietnam, occupational-safety and PPE framework) · accessed 2026-06-15 · reference · used in 1 rows
- Government of Vietnam — Decree No. 98/2021/ND-CP on management of medical devices (vanban.chinhphu.vn) · accessed 2026-06-15 · reference · used in 1 rows