CROSS-STANDARD public interest · PPE / respirator (mask)

China-to-Japan PPE Respirator (Dust 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 Japan requirements under the Industrial Safety and Health Act (労働安全衛生法), national Type Approval (型式検定) of dust masks (防じんマスク) by TIIS, performance classes RL/RS/DL/DS per JIS T 8151, the mandatory Type Approval mark (型式検定合格標章), and the critical industrial dust mask vs. medical/surgical mask boundary administered separately under the Pharmaceuticals and Medical Devices Act (薬機法).

Dataset 2026-06-11 Last verified 2026-06-15 6 rows

Compliance Gap Matrix

Gap matrix
Compliance item Common China baseline Japan (PSE/JET) Gap / action Source + verification date
Conformity Assessment — National Type Approval (型式検定) of Dust Masks (Mandatory Third-Party Examination) 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 (Class II in most cases). Neither the CCC scheme nor the NMPA medical device registration is recognised as equivalent to Japan's national Type Approval (型式検定) by TIIS under the Industrial Safety and Health Act.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 Class II medical device registration)
Industrial dust masks (防じんマスク) are designated machines etc. (機械等) subject to mandatory national Type Approval (型式検定) under the Industrial Safety and Health Act (労働安全衛生法), Article 44-2 — they may not be transferred, lent, or supplied for protective use without a Type Approval pass. The Type Approval is performed by a registered conformity assessment body designated by the Minister of Health, Labour and Welfare — for dust masks this is TIIS (Technology Institution of Industrial Safety, 産業安全技術協会). The procedure: (1) the manufacturer or importer applies to TIIS submitting technical documentation, product specimens, and the manufacturing/quality-control method; (2) TIIS conducts a TYPE EXAMINATION verifying the specimen meets JIS T 8151 performance (capture efficiency, breathing resistance, leakage, exhalation valve, etc.) AND examines the manufacturing and inspection method to ensure conformity of production; (3) on pass, TIIS issues a Type Approval certificate (型式検定合格証) and the model is entered on the public list of approved 防じんマスク. The manufacturer/importer cannot self-certify — third-party Type Approval by TIIS is mandatory throughout, and conformity-of-production controls are part of the examination scope.Industrial Safety and Health Act (労働安全衛生法) — Article 44-2 (Type Approval 型式検定 of designated machines etc.), Article 42 (standards for designated protective equipment)
Ordinance on Industrial Safety and Health (労働安全衛生規則) and the Type Approval ministerial standards for 防じんマスク
JIS T 8151 — performance standard applied during the TIIS Type Examination
The entire conformity assessment must be re-run as a Japanese national Type Approval (型式検定). Specific gaps: (1) The Type Approval must be performed by TIIS, the registered body designated for dust masks under the Industrial Safety and Health Act — no other route exists; (2) Chinese CCC certificates and NMPA registrations do not substitute for the TIIS Type Examination; (3) a Type Approval certificate (型式検定合格証) must be obtained BEFORE the Type Approval mark (型式検定合格標章) may be affixed and the product supplied; (4) conformity of production is examined as part of Type Approval — the manufacturing and inspection method must be documented; (5) the Type Approval is tied to the specific model — design changes generally require re-examination; (6) the importer must hold the technical file and Type Approval documentation and is responsible for ensuring only approved models are supplied for workplace use.[INFORMATIONAL] Industrial dust masks (防じんマスク) require mandatory national Type Approval (型式検定) by TIIS, which covers both the type examination against JIS T 8151 and the conformity-of-production method. Chinese CCC or NMPA certifications do not satisfy this requirement. Exporters and importers must engage TIIS, the registered Type Approval body designated under the Industrial Safety and Health Act, and obtain the Type Approval certificate before any dust mask is supplied for workplace use in Japan. TIIS — Technology Institution of Industrial Safety (産業安全技術協会)2026-06-15 · reference
Product Labelling and Marking Requirements — Dust Masks (JIS T 8151 + Type Approval) GB 2626-2019 Clause 7 specifies Chinese marking requirements for non-powered air-purifying particle respirators. Required on the product: manufacturer name or trademark, product name, product model, standard number (GB 2626-2019), performance class (KN90 or KN95), 'NR' or 'R' designation. Required on the packaging: manufacturer name, address, and contact, production date and shelf life (or expiry date), lot number, storage conditions, instructions for use in Chinese. The CCC mark must appear on the product and packaging. Key differences from Japan: Chinese markings are in Chinese only (Japan requires Japanese); the CCC mark replaces the Type Approval mark (型式検定合格標章); China's KN/KP coding differs from Japan's RL/RS/DL/DS class coding; and there is no Type Approval number requirement.GB 2626-2019 — Clause 7 (Marking and packaging requirements)
China CCC (3C) mark — mandatory product certification mark on product and packaging
JIS T 8151 specifies mandatory marking to be permanently and legibly applied to each particulate respirator (dust mask) and, together with the Industrial Safety and Health Act Type Approval, governs what must appear on the product and packaging. Required markings ON THE DEVICE include: (1) the standard reference (JIS T 8151); (2) the manufacturer name or registered trademark; (3) the type/model designation; (4) the performance class (one of RL1/RL2/RL3, RS1/RS2/RS3, DL1/DL2/DL3, DS1/DS2/DS3) indicating test aerosol (R = oil mist, S/D = NaCl), reusability (L = replaceable, S = single-use), and capture grade (1/2/3); (5) the Type Approval mark (型式検定合格標章) and Type Approval number once approved. Required on the PACKAGING: manufacturer name and address, lot/batch number, storage conditions, and instructions for use in Japanese. Instructions for use (取扱説明書) must include: donning/doffing and fit-check (シールチェック) procedure, limitations of use (e.g., not for oxygen-deficient or gas/vapour environments), the performance class and its meaning, storage conditions, and replacement/maintenance guidance (for replaceable RL/DL types). The instructions and product-facing markings must be in Japanese.JIS T 8151 — Marking requirements for particulate respirators (performance class, reusability, capture grade, standard reference)
Industrial Safety and Health Act (労働安全衛生法) — Type Approval mark (型式検定合格標章) and supply/labelling obligations
Act against Unjustifiable Premiums and Misleading Representations (景品表示法) — general prohibition on misleading product claims/labelling in Japan
Multiple labelling gaps are typical for Chinese manufacturers: (1) LANGUAGE: Chinese-only instructions do not satisfy Japan — full Japanese instructions for use (取扱説明書) are required. (2) TYPE APPROVAL MARK: The Type Approval mark (型式検定合格標章) plus Type Approval number must appear on the product; the CCC mark must be removed or must not be presented as a Japanese conformity mark. (3) CLASS CODE: The product must carry a JIS T 8151 class (e.g., RL2, RS2, DS2, DL3) rather than KN90/KN95; the manufacturer must not relabel a KN95 as 'DS2-equivalent' without actual JIS testing and Type Approval. (4) STANDARD CITATION: The product must reference JIS T 8151, not GB 2626-2019. (5) USE LIMITATIONS: Japanese instructions must state the limitations clearly (e.g., dust masks do not protect against gases/vapours or in oxygen-deficient atmospheres) and include the fit-check (シールチェック) procedure. (6) NO 'KN95' PROTECTIVE CLAIM: Labelling a non-Type-Approved KN95 as workplace respiratory protective equipment is non-compliant — only Type-Approved models bearing the 型式検定合格標章 may be supplied for workplace use, and misleading class claims may also breach the Act against Unjustifiable Premiums and Misleading Representations (景品表示法).[INFORMATIONAL] Dust masks for the Japanese workplace market require product labelling that complies with JIS T 8151 (performance class RL/RS/DL/DS, reusability, capture grade, standard number) and the Industrial Safety and Health Act (Type Approval mark 型式検定合格標章 plus Type Approval number). Instructions for use must be in Japanese and state the use limitations and fit-check procedure. Chinese-language-only labelling, CCC marks, and GB 2626 standard/KN class references are not sufficient. Supplying a non-Type-Approved KN95 as workplace respiratory protective equipment, or making a misleading class claim, is non-compliant in Japan. JISC — Japanese Industrial Standards Committee (日本産業標準調査会)2026-06-15 · reference
Type Approval Mark (型式検定合格標章), Approval Documentation, and Importer Obligations China does not require the Japanese Type Approval mark. Domestic market conformity is demonstrated via the CCC mark (mandatory for GB 2626 respirators) or NMPA registration (for GB 19083 medical masks). The CCC mark (China Compulsory Certification) is affixed after certification by a CNCA-authorised body. There is no equivalent to the Japanese importer-of-record supply obligation under the Industrial Safety and Health Act — Chinese law does not mandate the same workplace-supply duty for the domestic market conformity pathway. The CCC mark and NMPA registration documents are not accepted by Japanese authorities as evidence of Type Approval.China CCC (3C) certification — CNCA mandatory certification system for GB 2626-2019 industrial respirators
NMPA medical device registration — for GB 19083 medical-protective masks under drug/device law
Before supplying an industrial dust mask (防じんマスク) for workplace use in Japan, the manufacturer or importer must: (1) Affix the Type Approval mark (型式検定合格標章) to each approved product — this mark is granted only after a Type Approval pass and certifies the model is on the TIIS list of approved dust masks; supplying an unmarked dust mask for protective use is prohibited under the Industrial Safety and Health Act (労働安全衛生法); (2) Hold the Type Approval certificate (型式検定合格証) issued by TIIS, which identifies the model, the performance class (e.g., RL2, RS2, DL3, DS2 per JIS T 8151), the approval number, and the approval date; (3) Ensure the product marking shows the manufacturer name, model designation, performance class, and the Type Approval number, consistent with JIS T 8151 marking and the Type Approval. For imported products, the IMPORTER is the party responsible for ensuring Type Approval has been obtained and the mark is correctly applied — Japan has no statutory 'Authorised Representative' construct for masks, but the importer of record carries the supply-obligation and record-keeping duties. Note: the PSE mark (electrical) and J-Moss/RoHS marking do not apply to non-powered masks.Industrial Safety and Health Act (労働安全衛生法) — Article 44-2 (Type Approval mark 型式検定合格標章; prohibition on supplying unmarked designated equipment)
Type Approval ministerial standards for 防じんマスク and JIS T 8151 marking provisions
Three distinct gaps must be closed: (1) TYPE APPROVAL MARK: The Type Approval mark (型式検定合格標章) must be physically on each approved dust mask. Existing CCC or Chinese quality marks do not satisfy this and an unmarked product cannot be supplied for workplace use. (2) TYPE APPROVAL CERTIFICATE: A Type Approval certificate (型式検定合格証) from TIIS must be obtained, identifying the model and its JIS T 8151 performance class — this is the document, not a self-declaration, that authorises supply. (3) IMPORTER SUPPLY OBLIGATION: The importer of record must verify that the model holds a valid Type Approval before supplying it as workplace respiratory protective equipment and must retain the approval documentation. Chinese manufacturers commonly export with only GB 2626 / KN95 test reports and the CCC mark — these must be replaced by a Japanese Type Approval and its mark before lawful workplace supply. The CCC mark should not appear as if it were a Japanese conformity mark.[INFORMATIONAL] All three elements — the Type Approval mark (型式検定合格標章), the Type Approval certificate (型式検定合格証) from TIIS, and the importer's supply-obligation/record-keeping under the Industrial Safety and Health Act — are required before any industrial dust mask is supplied for workplace use in Japan. These are distinct from the JIS T 8151 technical testing and follow the TIIS Type Approval pass. Chinese CCC marks, NMPA marks, and Chinese quality certificates do not substitute for any of these requirements. The PSE mark does not apply to non-powered masks. TIIS — Technology Institution of Industrial Safety (産業安全技術協会)2026-06-15 · reference
Particulate Respirator Safety — JIS T 8151 RL/RS/DL/DS Performance Requirements 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 two performance classes: KN90 and KN95. GB 2626-2019 is a mandatory national standard (GB, not GB/T) enforced by SAMR. KN95 requires >=95% filtration efficiency against NaCl particles at 85 L/min flow rate. Key differences from JIS T 8151: GB 2626 KN classes use sodium chloride (NaCl) aerosol only (the JIS R-series additionally requires paraffin/DOP oil-mist testing, equivalent to GB 2626's KP series); China's KN/KP coding and Japan's S/R + L/S coding are not interchangeable; and Chinese Type Test plus CCC factory inspection is not recognised under Japan's national Type Approval (型式検定) pathway.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 use — not industrial PPE)
Industrial dust masks (防じんマスク) supplied for workplace respiratory protection in Japan must meet the performance requirements of JIS T 8151 (Respiratory protective devices — Particulate respirators) and pass national Type Approval (型式検定) under the Industrial Safety and Health Act (労働安全衛生法). JIS T 8151 defines particle-capture classes by both test aerosol and reusability: the LETTER indicates the test aerosol — R = tested with paraffin/dioctyl phthalate oil mist (liquid-oily particles), S = tested with sodium chloride (NaCl, solid particles); the next LETTER indicates reusability — L = replaceable (取替え式, reusable facepiece) and S = single-use/disposable (使い捨て式); the NUMBER indicates capture efficiency grade: 1 (>=80%), 2 (>=95%), 3 (>=99.9%). Combined designations are RL1/RL2/RL3, RS1/RS2/RS3, DL1/DL2/DL3, DS1/DS2/DS3 (D denotes the solid-NaCl-only series in the older nomenclature; current JIS aligns S/R aerosol coding). Requirements cover particle capture efficiency, inhalation and exhalation breathing resistance, dead space (CO2 / leakage), and total inward leakage. The oil-mist (R-series) test is a defining feature absent from China's GB 2626 KN classes, which test NaCl only.Industrial Safety and Health Act (労働安全衛生法) — mandatory Type Approval (型式検定) of dust masks 防じんマスク
JIS T 8151 — Respiratory protective devices — Particulate respirators — Requirements, testing, marking (performance standard for Type Approval; classes RL/RS/DL/DS, grades 1/2/3)
Exporters must obtain JIS T 8151 testing and national Type Approval (型式検定) from TIIS. GB 2626-2019 (KN95) test reports do NOT satisfy JIS T 8151 or Type Approval because: (1) JIS R-series classes require paraffin/DOP oil-mist testing (KN classes test NaCl only — the GB 2626 oil-equivalent is the separate KP series, which most KN95 exporters have not tested); (2) Japan's class coding (RL/RS/DL/DS + grade 1/2/3) is structurally different from China's KN90/KN95, so there is no direct numeric crosswalk; (3) the product must pass the mandatory national Type Approval (型式検定) examination conducted by TIIS, not merely a private lab test. A complete re-test to JIS T 8151 plus Type Approval is required — partial bridging from GB 2626 is not accepted.[INFORMATIONAL] Industrial dust masks are subject to mandatory national Type Approval (型式検定) under the Industrial Safety and Health Act (労働安全衛生法). The Type Approval mark (型式検定合格標章) is mandatory and requires examination by TIIS plus performance to JIS T 8151 (classes RL/RS/DL/DS, grades 1/2/3). Chinese GB 2626-2019 (KN95) certification does not satisfy Japanese requirements — full re-testing and Type Approval are required, including the paraffin/DOP oil-mist (R-series) test absent from GB 2626 KN classes. TIIS — Technology Institution of Industrial Safety (産業安全技術協会)2026-06-15 · reference
Medical-Protective Respirator Safety — GB 19083 (China Only — Not the Industrial Type Approval Route) GB 19083-2010 (Technical requirements for medical protective mask) requires >=95% filtration efficiency (NaCl aerosol), bacterial filtration efficiency, surface moisture resistance, and pressure differential testing. It is enforced by NMPA (National Medical Products Administration) as a medical device in China. Products certified under GB 19083 in China are regulated as medical devices domestically, not as industrial PPE under GB 2626. The Japanese equivalent route would require BOTH national Type Approval (型式検定) under the Industrial Safety and Health Act (for the protective function, to JIS T 8151) AND Pharmaceuticals and Medical Devices Act (薬機法) conformity (for the medical function) — a dual-regime pathway.GB 19083-2010 — Technical requirements for medical protective mask (NMPA, medical device classification) This row addresses the Chinese medical-protective respirator standard (GB 19083) for completeness. In Japan, a respirator that serves both a workplace protective function (particle filtration) and a medical function (infection control, medical claim) falls across two separate regimes: the Industrial Safety and Health Act (労働安全衛生法, Type Approval 型式検定 of 防じんマスク) for the protective function AND the Pharmaceuticals and Medical Devices Act (薬機法, PMD Act, MHLW/PMDA) for the medical function. There is no single Japanese 'medical-protective respirator' approval that bundles both. The industrial dust mask route covered in this comparison is the Type Approval route under JIS T 8151. See the scope fragment (ppejp-scope) for the critical industrial vs. medical boundary.GB 19083-2010 — Technical requirements for medical protective mask (China, mandatory, SAMR/NMPA)
Industrial Safety and Health Act (労働安全衛生法, Type Approval 型式検定) and Pharmaceuticals and Medical Devices Act (薬機法) — separate Japanese regimes for protective vs. medical respirators
GB 19083 certification is for China's domestic medical device market and has no direct Japanese equivalent recognition. Exporting a GB 19083-certified respirator to Japan as a workplace dust mask still requires full JIS T 8151 testing plus national Type Approval (型式検定) by TIIS. If the product also claims medical functionality (e.g., medical/surgical use, medical effect), it additionally requires Pharmaceuticals and Medical Devices Act (薬機法) conformity via MHLW/PMDA. The dual-regime pathway is significantly more burdensome than the industrial-only (JIS T 8151 + Type Approval) path.[INFORMATIONAL] GB 19083 (Chinese medical-protective mask) certification is not recognised under either the Japanese Industrial Safety and Health Act Type Approval (型式検定) route or the PMD Act (薬機法) route. Exporters must choose the correct Japanese route: industrial-only (JIS T 8151 + Type Approval by TIIS) or dual industrial+medical (adding PMD Act conformity) if medical claims are made. See the scope fragment for the medical mask / dust mask boundary which determines which regime applies. MHLW — Ministry of Health, Labour and Welfare (厚生労働省)2026-06-15 · reference
CRITICAL BOUNDARY: Industrial Dust Mask vs. Medical/Surgical Mask — Which Japanese Law Applies? China uses a three-track classification system for respiratory masks: (1) INDUSTRIAL / NON-MEDICAL: GB 2626-2019 (KN90/KN95) — particle respirators for occupational use, mandatory CCC, administered by SAMR; (2) MEDICAL-PROTECTIVE: GB 19083-2010 (>=95% filtration, medical-grade) — for use in highly infectious environments (e.g., SARS, COVID wards), administered by NMPA as Class II medical device; (3) SURGICAL MASK: YY 0469-2011 (Medical surgical mask — Technical requirements) — for surgical use, bacterial filtration efficiency >=95%, NMPA Class II medical device. The Chinese three-track system partially maps to Japan's two-regime system, but the mapping is not 1:1. Notably: KN95 (GB 2626) != DS2/RS2 (JIS T 8151) because test methods and oil-mist requirements differ; and China's YY 0469 surgical masks map to the Japanese PMD Act (薬機法) medical route, not to the Industrial Safety and Health Act Type Approval route.GB 2626-2019 — Non-powered air-purifying particle respirator (KN90/KN95) — SAMR/CCC
GB 19083-2010 — Technical requirements for medical protective mask — NMPA Class II
YY 0469-2011 — Medical surgical mask — Technical requirements — NMPA Class II
GB/T 32610-2016 — Technical specification of daily protective mask (voluntary, general public — not industrial or medical)
The industrial-vs-medical boundary is one of the most commercially significant classification decisions for respiratory protection products entering the Japanese market. The determining factor is the INTENDED PURPOSE declared by the manufacturer: (A) INDUSTRIAL DUST MASKS (型式検定 ROUTE): Products intended to protect the WEARER against airborne dust, fumes, mists, and particles in the workplace (occupational safety). Route: Industrial Safety and Health Act (労働安全衛生法), Article 42 and 44-2, mandatory national Type Approval (型式検定) of 防じんマスク performed by TIIS, performance classes per JIS T 8151 (RL/RS/DL/DS). The Type Approval mark (型式検定合格標章) is mandatory. (B) SURGICAL / MEDICAL MASKS (PMD ACT ROUTE): Products intended for medical use, infection control, or claiming medical effect. Route: Pharmaceuticals and Medical Devices Act (薬機法, PMD Act) administered by MHLW / PMDA. Industrial Type Approval does NOT apply. General-population non-medical hygiene masks that make no medical claim and no protective claim fall outside both regimes (governed only by general consumer/labelling law). (C) DUAL-PURPOSE PRODUCTS: A product claiming BOTH workplace particle protection (Industrial Safety and Health Act) AND a medical effect (PMD Act) must satisfy BOTH regimes. This dual path is significantly more burdensome. Note Japan has no PSE/electrical route for masks — PSE under the Electrical Appliances and Materials Safety Act (電気用品安全法) applies only to powered electrical products and is irrelevant to non-powered filtering facepieces.Industrial Safety and Health Act (労働安全衛生法) — Articles 42, 44-2 (dust masks 防じんマスク protecting the wearer: Type Approval 型式検定 route)
Pharmaceuticals and Medical Devices Act (薬機法, PMD Act) — MHLW/PMDA (surgical/medical masks claiming medical effect)
JIS T 8151 — Respiratory protective devices — Particulate respirators (Type Approval performance standard, classes RL/RS/DL/DS)
型式検定合格標章 — Type Approval mark mandatory on approved dust masks under the Industrial Safety and Health Act
The single most important classification decision is: what does the product label and intended-use statement claim? (1) If the product claims WEARER PROTECTION against workplace dust/particles (worker safety, industrial): -> Industrial Safety and Health Act (労働安全衛生法) applies -> national Type Approval (型式検定) of 防じんマスク by TIIS is mandatory, performance to JIS T 8151. (2) If the product claims a MEDICAL EFFECT or is intended for surgical/medical use: -> PMD Act (薬機法) applies -> notification/approval via MHLW/PMDA, industrial Type Approval does not apply. (3) If the product claims BOTH: -> Both regimes apply. COMMON EXPORT MISTAKE: Chinese manufacturers label KN95 (GB 2626) masks with 'surgical' or 'medical' language to target multiple markets. In Japan, an industrial protective claim mandates Type Approval (型式検定) — and a medical claim separately triggers the PMD Act. Importing an industrial respirator into Japan with only a GB 2626 / KN95 test report and no Type Approval mark means the product cannot lawfully be supplied as workplace respiratory protective equipment.[INFORMATIONAL - CRITICAL BOUNDARY] Surgical/medical masks in Japan are regulated under the Pharmaceuticals and Medical Devices Act (薬機法) via MHLW/PMDA, NOT under the Industrial Safety and Health Act. Industrial dust masks (防じんマスク) protecting the wearer require national Type Approval (型式検定) by TIIS to JIS T 8151 — a completely different regulatory route. The two routes must not be mixed. Products claiming both functions require dual conformity. Chinese KN95 (GB 2626) respirators exported to Japan for workplace use must follow the Type Approval (型式検定) route — adding 'surgical' or 'medical' labelling separately triggers PMD Act requirements that are frequently absent. Note: PSE under the Electrical Appliances and Materials Safety Act does not apply to non-powered masks. TIIS — Technology Institution of Industrial Safety (産業安全技術協会)2026-06-15 · reference

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