Conformity Assessment — BSTI Mandatory Certification Mark and In-Country Importer?

Respirators entering Bangladesh are assessed by BSTI against a BDS standard that adopts EN 149, with a mandatory BSTI Certification Mark licence for products on the compulsory list and an in-country importer of record. Chinese CCC certificates and GB 2626 test reports are not auto-accepted because GB 2626 and EN 149 use different test methods. Bangladesh has no Notified-Body system; medical/surgical masks are handled by DGDA, not BSTI. Confirm BSTI list status and engage a Bangladesh importer before shipment.

Product Labelling and Marking — Filtering Respirators (BDS/EN 149 + BSTI + Importer Details)?

For the Bangladesh market, mark filtering respirators to the EN 149-based BDS scheme (standard number, FFP class, NR/R, D), add the BSTI standard mark/licence reference where the product is listed, include the in-country importer's details, and provide instructions in English and/or Bangla as the buyer requires. Do not rely on the 'KN95'/GB 2626 notation or the CCC mark as in-market conformity evidence. No CE mark, Notified-Body number, or EU horizontal-regime (RoHS/battery/noise) labelling applies.

BSTI Certification Mark, Conformity Documentation, and In-Country Importer of Record?

For the Bangladesh market, where the respirator is on the BSTI compulsory list a BSTI Certification Mark licence and the BSTI standard mark are required, supported by BSTI-accepted test reports against the BDS/EN 149 standard and import-clearance paperwork, with an in-country importer of record holding the BSTI/customs relationship. Chinese CCC marks and NMPA registrations do not substitute. There is no Notified-Body identification number and no EU-style horizontal declaration to add.

Filtering Facepiece Respirator Safety — BDS Standard Adopting EN 149 Performance Requirements?

Bangladesh assesses occupational filtering respirators against a BDS standard that adopts EN 149 (FFP1/FFP2/FFP3). Chinese GB 2626-2019 (KN95) certification does not satisfy this, because EN 149 additionally requires paraffin-oil aerosol testing, a simulated-workplace total-inward-leakage test, and (for D-marked masks) a dolomite clogging test absent from GB 2626. Obtain BSTI-acceptable EN 149 testing and, where the product is on the BSTI compulsory list, the CM licence before sale.

Occupational Safety Framework — Employer PPE Provision under the Bangladesh Labour Law?

Bangladesh has no dedicated EU-style PPE Regulation; occupational respirator use is driven by the labour-law framework (Bangladesh Labour Act 2006 / Labour Rules 2015, enforced by DIFE), which obliges employers to provide suitable respiratory protection. The exporter's compliance task is to meet the BDS/EN 149 product standard (and BSTI licence where listed) and to supply performance-class, fit, instructions, and maintenance documentation so the importer/employer can discharge its statutory duty. No RoHS, battery, or outdoor-noise regime applies on top.

CRITICAL BOUNDARY: PPE Respirator (BSTI) vs. Medical/Surgical Mask (DGDA) — Which Route Applies??

In Bangladesh the mask's intended purpose decides the route: occupational filtering respirators go to BSTI against a BDS standard adopting EN 149 (plus a BSTI CM licence where listed and the labour-law occupational framework), while medical/surgical masks go to DGDA as medical devices. The two routes must not be mixed. Adding 'medical' or 'surgical' wording to a KN95 (GB 2626) industrial mask pulls it into the DGDA route. Bangladesh has no EU-style horizontal regimes (no RoHS, battery, or outdoor-noise rules) to satisfy in addition.

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

China-to-Bangladesh PPE Respirator (FFP Mask) Compliance Gap Matrix

Name: China-to-Bangladesh PPE Respirator (FFP Mask) Compliance Gap Matrix
Creator: Cross-Standard
License: https://creativecommons.org/licenses/by/4.0/

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 Bangladesh market-access requirements: BSTI (Bangladesh Standards and Testing Institution) mandatory certification mark, the BDS respirator standard that adopts EN 149, the labour-law occupational safety framework, in-country importer obligations, and the DGDA medical-device route for surgical/medical masks. Bangladesh lacks an EU-style horizontal regime (no RoHS, no battery regulation, no outdoor-noise directive).

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

Short answer

Filtering respirators entering Bangladesh are governed by the Bangladesh Standards and Testing Institution (BSTI) and the BDS national standard, which adopts EN 149 for filtering half masks. Where a product falls within BSTI's mandatory certification mark list, the BSTI certification mark and in-country importer obligations apply; occupational use is framed by the labour-law safety regime rather than a dedicated PPE regulation. Medical/surgical masks are routed through the Directorate General of Drug Administration (DGDA) as medical devices, not through the PPE/BSTI route. Chinese KN95 (GB 2626) test reports are built to a different test method than EN 149 and do not by themselves satisfy the BDS/EN 149 route. Bangladesh does not operate EU-style horizontal regimes (no RoHS, no battery regulation, no outdoor-noise directive).

GAP MATRIX

Compliance Gap Matrix

Gap matrix
Compliance item	Common China baseline	Bangladesh (BSTI)	Gap / action	Source + verification date
Conformity Assessment — BSTI Mandatory Certification Mark and In-Country Importer	For industrial respiratory protection under GB 2626-2019 (KN95), China applies a compulsory certification (CCC) scheme administered by SAMR/CNCA and authorised third-party certification bodies (e.g., CQC), involving type testing by a CNAS-accredited laboratory followed by factory inspection. For medical-protective masks (GB 19083), NMPA registration is required as a Class II medical device. Neither the Chinese CCC scheme nor NMPA registration is automatically recognised by BSTI; a BSTI licence (for listed products) and BSTI-accepted testing against the adopted BDS/EN 149 standard are assessed independently, and the medical-mask route in Bangladesh runs through DGDA rather than BSTI.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (CCC under SAMR/CNCA) GB 19083-2010 — Technical requirements for medical protective mask (NMPA Class II medical device registration)	In Bangladesh, conformity for regulated products is administered by the Bangladesh Standards and Testing Institution (BSTI) under the Bangladesh Standards and Testing Institution Act, 2018. BSTI operates a mandatory certification mark scheme (the CM, or Certification Mark, licence) for products listed in its compulsory-certification product list; for such products a BSTI licence and the BSTI standard mark are required before the goods can be lawfully sold. For imported goods, BSTI also operates a Pre-Shipment Inspection / import clearance certificate route, and the importer of record established in Bangladesh holds the regulatory relationship with BSTI and customs. Filtering respirators are assessed against the relevant BDS national standard, which adopts EN 149 for filtering half masks. Where the specific respirator type is not on the compulsory list, market entry still relies on the importer demonstrating conformity to the adopted BDS/EN 149 standard and, for workplace supply, satisfying the labour-law occupational framework. BSTI conformity is evidenced by BSTI-accepted test reports plus the BSTI licence, not by a foreign self-declaration alone.Bangladesh Standards and Testing Institution Act, 2018 (BSTI mandate, Certification Mark / CM licence scheme) BSTI compulsory certification mark product list (regulated products requiring a BSTI licence before sale) BDS national standard for filtering half-mask respirators (adopting EN 149) administered by BSTI	The conformity pathway must be re-run for Bangladesh: (1) Determine whether the specific respirator is on the BSTI compulsory certification mark product list — if so, a BSTI CM licence is required before sale and the BSTI standard mark must be applied; (2) Appoint an in-country importer of record established in Bangladesh, who holds the BSTI and customs relationship — there is no remote self-certification equivalent; (3) Provide BSTI-acceptable testing against the adopted BDS/EN 149 standard — Chinese CCC certificates and GB 2626 test reports are not auto-accepted because GB 2626 and EN 149 use different test methods; (4) Comply with BSTI import clearance / pre-shipment requirements so goods clear at Chattogram or Mongla; (5) For any product carrying medical/surgical claims, the route shifts to DGDA medical-device registration, not BSTI. Bangladesh has no EU-style Notified Body system and no horizontal RoHS/battery/noise regimes — those steps do not apply here.[INFORMATIONAL] Respirators entering Bangladesh are assessed by BSTI against a BDS standard that adopts EN 149, with a mandatory BSTI Certification Mark licence for products on the compulsory list and an in-country importer of record. Chinese CCC certificates and GB 2626 test reports are not auto-accepted because GB 2626 and EN 149 use different test methods. Bangladesh has no Notified-Body system; medical/surgical masks are handled by DGDA, not BSTI. Confirm BSTI list status and engage a Bangladesh importer before shipment.	Bangladesh Standards and Testing Institution (BSTI), Ministry of Industries, Government of Bangladesh2026-06-15 · reference
Product Labelling and Marking — Filtering Respirators (BDS/EN 149 + BSTI + Importer Details)	GB 2626-2019 (Clause 7) specifies Chinese marking: manufacturer name or trademark, product name, model, standard number (GB 2626-2019), performance class (KN90/KN95), and 'NR'/'R'. Packaging must show manufacturer name, address and contact, production date and shelf life (or expiry), lot number, storage conditions, and Chinese-language instructions for use; the CCC mark appears on product and packaging where applicable. Key differences from Bangladesh: Chinese markings reference GB 2626 and use KN classes, are in Chinese only, and carry the CCC mark — whereas the Bangladesh market expects EN 149-style class marking (FFP1/2/3), the BSTI mark (where listed), importer details, and usable English/Bangla instructions.GB 2626-2019 — Clause 7 (Marking and packaging requirements) China CCC (3C) mark — on product and packaging where applicable	Because the Bangladesh respirator standard adopts EN 149, the device marking expected on the product follows the EN 149 marking scheme: number/year of the standard, manufacturer name or trademark, type designation, performance class (FFP1/FFP2/FFP3), 'NR' (non-reusable) or 'R' (reusable), and 'D' where the dolomite clogging test was passed — applied permanently and legibly to each respirator and its packaging. In addition, for the Bangladesh market: (1) where the product is on the BSTI compulsory list, the BSTI standard mark / licence reference must appear on the product or packaging; (2) packaging should carry manufacturer name and address, lot/batch number, storage conditions, and (commonly required) production/expiry or shelf-life information; (3) the in-country importer's name and address are expected on the import packaging/labelling for traceability and customs; (4) instructions for use covering donning/doffing, fit-check, limitations, storage, and maintenance (for R types) should be provided in a language usable in Bangladesh (English and/or Bangla as appropriate to the buyer/employer). There is no requirement to provide 24 EU-language variants, and no CE mark or Notified-Body number is used; the BSTI mark is the in-market conformity identifier.BDS national standard adopting EN 149 — Clause 9-equivalent marking (standard number, class, NR/R, D, manufacturer, type) Bangladesh Standards and Testing Institution Act, 2018 — BSTI standard mark / licence reference on product or packaging Bangladesh import labelling and customs requirements — importer name/address and traceability information	Typical labelling gaps for Chinese exporters to Bangladesh: (1) CLASS NOTATION: re-mark to EN 149 classes (FFP1/FFP2/FFP3) and reference the BDS/EN 149 standard rather than relying solely on the 'KN95' / GB 2626 notation — presenting a KN95 product as an EN 149 FFP class without EN 149 testing is misleading because the test methods differ; (2) BSTI MARK: where the product is on the BSTI compulsory list, add the BSTI standard mark / licence reference and do not present the CCC mark as the in-market conformity mark; (3) IMPORTER DETAILS: add the Bangladesh importer's name and address for customs and traceability; (4) LANGUAGE: provide instructions for use in English and/or Bangla as needed by the importer/employer (not Chinese-only) — but there is no 24-EU-language obligation; (5) SHELF LIFE/LOT: keep clear lot number and shelf-life marking for occupational buyers and DIFE-relevant traceability. No CE mark, Notified-Body number, or EU horizontal-regime labelling (RoHS/battery/noise) applies.[INFORMATIONAL] For the Bangladesh market, mark filtering respirators to the EN 149-based BDS scheme (standard number, FFP class, NR/R, D), add the BSTI standard mark/licence reference where the product is listed, include the in-country importer's details, and provide instructions in English and/or Bangla as the buyer requires. Do not rely on the 'KN95'/GB 2626 notation or the CCC mark as in-market conformity evidence. No CE mark, Notified-Body number, or EU horizontal-regime (RoHS/battery/noise) labelling applies.	Bangladesh Standards and Testing Institution (BSTI), Ministry of Industries, Government of Bangladesh2026-06-15 · reference
BSTI Certification Mark, Conformity Documentation, and In-Country Importer of Record	China does not use the BSTI mark. Domestic conformity is shown via the CCC mark (mandatory for GB 2626 respirators where applicable) affixed after certification by a CNCA-authorised body, or NMPA registration for GB 19083 medical masks. China's domestic-market pathway does not require a foreign-style in-country representative, and the CCC mark/NMPA registration are not accepted by BSTI or Bangladesh customs as evidence of conformity to the BDS/EN 149 standard. The function of the BSTI mark (in-market conformity identifier) is performed in China by the CCC mark, but the marks are not interchangeable across the two markets.China CCC (3C) certification — CNCA mandatory certification mark for applicable GB 2626-2019 respirators NMPA medical device registration — for GB 19083 medical-protective masks	Before a regulated filtering respirator can be lawfully sold in Bangladesh, the responsible party must close three elements: (1) BSTI CERTIFICATION MARK: where the product type is on the BSTI compulsory certification mark list, a BSTI licence must be obtained and the BSTI standard mark applied to the product/packaging — this is the in-market conformity mark, analogous in function to (but not interchangeable with) a CE mark; (2) CONFORMITY DOCUMENTATION: BSTI-accepted test reports demonstrating conformity to the BDS standard adopting EN 149, the product's technical file, and (for imports) the BSTI import clearance / pre-shipment documentation needed to clear customs at Chattogram or Mongla; (3) IN-COUNTRY IMPORTER OF RECORD: an importer established in Bangladesh holds the regulatory relationship — Bangladesh does not have an EU-Authorised-Representative concept, but a local importer/agent is in practice the entity that holds the BSTI licence/relationship and is answerable to BSTI and customs. There is no Notified-Body identification number system; the BSTI mark and licence number perform the in-market identification role.Bangladesh Standards and Testing Institution Act, 2018 — BSTI Certification Mark (CM) licence and standard mark BSTI import clearance / pre-shipment inspection requirements for regulated imported goods Imports and Exports (Control) Act and customs procedures — in-country importer of record at Chattogram / Mongla ports	Three gaps must be closed for Bangladesh: (1) BSTI MARK/LICENCE: confirm whether the respirator is on the BSTI compulsory certification mark list; if so, obtain the BSTI licence and apply the BSTI standard mark — the Chinese CCC mark does not substitute and must not be presented as the in-market conformity mark; (2) DOCUMENTATION FOR IMPORT: prepare BSTI-accepted test reports against the BDS/EN 149 standard plus the pre-shipment / import clearance paperwork required to clear at Chattogram or Mongla — a GB 2626 report alone will not clear the BSTI standard requirement; (3) IMPORTER OF RECORD: appoint a Bangladesh-established importer to hold the BSTI and customs relationship (functional substitute for the absent EU-Authorised-Representative concept). Note there is no Notified-Body number to add to the mark, and no horizontal EU-style declaration (RoHS/battery/noise) to draw up.[INFORMATIONAL] For the Bangladesh market, where the respirator is on the BSTI compulsory list a BSTI Certification Mark licence and the BSTI standard mark are required, supported by BSTI-accepted test reports against the BDS/EN 149 standard and import-clearance paperwork, with an in-country importer of record holding the BSTI/customs relationship. Chinese CCC marks and NMPA registrations do not substitute. There is no Notified-Body identification number and no EU-style horizontal declaration to add.	Bangladesh Standards and Testing Institution (BSTI), Ministry of Industries, Government of Bangladesh2026-06-15 · reference
Filtering Facepiece Respirator Safety — BDS Standard Adopting EN 149 Performance Requirements	China's primary standard for non-powered air-purifying particle respirators is GB 2626-2019, with classes KN90 and KN95; it is a mandatory national standard (GB) enforced by SAMR. KN95 requires >=95% filtration efficiency against NaCl particles at 85 L/min. Key differences from the EN 149 basis adopted by Bangladesh: GB 2626 uses sodium chloride (NaCl) aerosol only (EN 149 uses both NaCl and paraffin oil), does not include the EN 149 practical/simulated-workplace performance test in the same form, and does not include the dolomite clogging resistance test. A GB 2626 (KN95) report from a Chinese CNAS-accredited lab therefore does not by itself demonstrate conformity to the BDS/EN 149 standard used by BSTI.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, general public, not industrial PPE)	Filtering facepiece respirators supplied in Bangladesh as occupational/industrial PPE are assessed against the relevant BDS national standard, which adopts EN 149 for filtering half masks. As an EN 149-based standard it carries the same three performance classes: FFP1 (filter penetration corresponding to roughly 80% efficiency), FFP2 (>=94% filtration, total inward leakage <=8%) and FFP3 (>=99% filtration, total inward leakage <=2%). The requirements cover filtration efficiency against both solid (sodium chloride) and liquid (paraffin oil) aerosols, inhalation and exhalation breathing resistance, carbon dioxide content of inhaled air, practical performance (simulated workplace) testing, dolomite clogging resistance for the 'D'-marked variant, and flammability. Devices are designated 'NR' (non-reusable) or 'R' (reusable). Because Bangladesh adopts EN 149 directly, the substantive technical bar is the EN 149 test programme rather than a separately drafted national methodology; BSTI relies on BSTI-accepted test reports demonstrating conformity to that adopted standard.BDS national standard for filtering half masks adopting EN 149 (FFP1/FFP2/FFP3) — administered by BSTI EN 149:2001+A1:2009 — Respiratory protective devices — Filtering half masks to protect against particles (basis standard adopted by the BDS)	Because Bangladesh adopts EN 149, exporters should obtain EN 149:2001+A1:2009 testing acceptable to BSTI. GB 2626-2019 (KN95) reports do not satisfy the BDS/EN 149 bar because: (1) EN 149 requires paraffin oil aerosol testing in addition to NaCl; (2) EN 149 requires a simulated-workplace total-inward-leakage test on human subjects; (3) EN 149 requires the dolomite clogging test for 'D'-marked masks. Filtration thresholds are also numerically different (KN95 = 95% NaCl only; FFP2 = 94% against both aerosols plus a total-inward-leakage limit). A full EN 149 test programme acceptable to BSTI is needed; partial bridging from GB 2626 is not sufficient, and BSTI may require testing in/recognised by an accepted laboratory plus the BSTI licence step.[INFORMATIONAL] Bangladesh assesses occupational filtering respirators against a BDS standard that adopts EN 149 (FFP1/FFP2/FFP3). Chinese GB 2626-2019 (KN95) certification does not satisfy this, because EN 149 additionally requires paraffin-oil aerosol testing, a simulated-workplace total-inward-leakage test, and (for D-marked masks) a dolomite clogging test absent from GB 2626. Obtain BSTI-acceptable EN 149 testing and, where the product is on the BSTI compulsory list, the CM licence before sale.	Bangladesh Standards and Testing Institution (BSTI), Ministry of Industries, Government of Bangladesh2026-06-15 · reference
Occupational Safety Framework — Employer PPE Provision under the Bangladesh Labour Law	China imposes parallel employer duties through its Work Safety Law (Safe Production Law) and the Law on the Prevention and Control of Occupational Diseases, requiring employers to provide compliant labour-protection articles (laodong fanghu yongpin), including respirators meeting GB 2626-2019, and to train workers in their use. The product standard (GB 2626) and the employer-provision duty are distinct, mirroring the Bangladesh split between the technical standard (BDS/EN 149) and the labour-law provision duty. The Chinese employer-provision rules are not recognised in Bangladesh; the Bangladesh labour inspectorate (DIFE) enforces its own framework, and the respirator must meet the BDS/EN 149 product standard regardless of Chinese occupational compliance.Work Safety Law of the People's Republic of China (Safe Production Law) — employer duty to provide labour-protection articles Law of the PRC on the Prevention and Control of Occupational Diseases — occupational exposure controls and PPE provision GB 2626-2019 — product standard for the supplied respirator	Bangladesh does not have a dedicated EU-style PPE Regulation; instead, occupational use of respirators is governed by the labour-law framework — principally the Bangladesh Labour Act, 2006 (as amended) and the Bangladesh Labour Rules, 2015. These place duties on the EMPLOYER to assess workplace hazards (including dust and airborne particulates) and to provide suitable personal protective equipment, including respiratory protection, to workers free of charge where exposure cannot otherwise be controlled. The labour framework is enforced by the labour inspectorate (Department of Inspection for Factories and Establishments, DIFE). This means demand for filtering respirators in Bangladesh is substantially employer-driven occupational supply: the product itself must meet the BDS/EN 149 technical standard (and BSTI requirements where listed), while the duty to select, provide, train on, and maintain the respirator sits with the employer under labour law. For an exporter, this affects documentation buyers expect — fit, performance class, instructions for use, and maintenance information that let the employer discharge its statutory duty.Bangladesh Labour Act, 2006 (as amended) — occupational health and safety / employer duty to provide PPE Bangladesh Labour Rules, 2015 — implementing rules on PPE provision and workplace safety Department of Inspection for Factories and Establishments (DIFE) — labour inspectorate enforcement	For an exporter the gap is documentary and positioning rather than a separate certificate: (1) Bangladesh has no standalone PPE conformity certificate beyond the BDS/EN 149 product standard plus the BSTI licence (where listed) — so satisfying the product-standard and BSTI steps is the core compliance task; (2) employer buyers (factories, garment/RMG plants, construction firms) need clear performance-class marking (FFP1/2/3), fit/sizing data, instructions for use, and maintenance/shelf-life information to discharge their labour-law duty and to satisfy DIFE inspection; (3) instructions and key safety information should be usable by the workforce (Bangla/English as appropriate); (4) there is no EU-style horizontal regime layered on top — no RoHS, no battery regulation, no outdoor-noise directive applies to a passive filtering respirator. The exporter should supply technical and usage documentation that lets the Bangladesh importer/employer meet both the BSTI/BDS standard and the labour-law provision duty.[INFORMATIONAL] Bangladesh has no dedicated EU-style PPE Regulation; occupational respirator use is driven by the labour-law framework (Bangladesh Labour Act 2006 / Labour Rules 2015, enforced by DIFE), which obliges employers to provide suitable respiratory protection. The exporter's compliance task is to meet the BDS/EN 149 product standard (and BSTI licence where listed) and to supply performance-class, fit, instructions, and maintenance documentation so the importer/employer can discharge its statutory duty. No RoHS, battery, or outdoor-noise regime applies on top.	ILO NATLEX — Bangladesh Labour Act, 2006 (national legislation database)2026-06-15 · reference
CRITICAL BOUNDARY: PPE Respirator (BSTI) vs. Medical/Surgical Mask (DGDA) — Which Route Applies?	China uses a three-track classification: (1) INDUSTRIAL / NON-MEDICAL: GB 2626-2019 (KN90/KN95) particle respirators for occupational use, CCC under SAMR; (2) MEDICAL-PROTECTIVE: GB 19083-2010 (medical-grade, high-filtration), regulated by NMPA as a Class II medical device; (3) SURGICAL MASK: YY 0469-2011, NMPA Class II medical device. This maps onto Bangladesh's institutional split: GB 2626 industrial respirators correspond to the BSTI / BDS-EN 149 occupational route, while GB 19083 medical-protective and YY 0469 surgical masks correspond to the DGDA medical-device route. As with the EU, KN95 (GB 2626) is not numerically interchangeable with EN 149 FFP classes because the test methods differ, so a KN95 report alone does not establish BDS/EN 149 conformity.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)	In Bangladesh the determining factor for which regulatory route a mask follows is the INTENDED PURPOSE declared by the manufacturer/importer. (A) FILTERING RESPIRATORS (BSTI / OCCUPATIONAL PPE ROUTE): products intended to protect the WEARER against airborne particles and aerosols (industrial, occupational, dust). These are assessed against the relevant BDS national standard adopting EN 149 (filtering half masks) and, where listed, require a BSTI Certification Mark licence; workplace supply is additionally framed by the labour-law occupational safety regime. (B) MEDICAL / SURGICAL MASKS (DGDA / MEDICAL DEVICE ROUTE): products intended to protect the PATIENT or environment from the wearer's emissions, or making medical/surgical/infection-control claims, are regulated as medical devices by the Directorate General of Drug Administration (DGDA) under the medical-device / drug administration framework, NOT through the BSTI PPE route. (C) DUAL-CLAIM PRODUCTS: a product claiming both wearer particle protection AND medical/surgical function may attract BOTH the BSTI/BDS respirator route AND DGDA medical-device registration. Unlike the EU there is no single harmonised PPE Regulation; the split here is institutional (BSTI vs DGDA) plus the labour-law occupational layer.BDS national standard for filtering half masks (adopting EN 149) — BSTI occupational/industrial respirator route Directorate General of Drug Administration (DGDA) medical-device / drug administration framework — surgical and medical masks route Bangladesh Labour Act, 2006 (as amended) and Bangladesh Labour Rules, 2015 — occupational safety / employer PPE-provision framework	The first decision is what the label and instructions claim. (1) If the product claims WEARER protection against particles/dust/aerosols (industrial/occupational): route to BSTI against the BDS standard adopting EN 149; if the respirator is on the BSTI compulsory list, a CM licence is mandatory, and workplace supply must also satisfy the labour-law occupational framework. (2) If the product claims PATIENT/ENVIRONMENT protection or carries medical/surgical/infection-control language: route to DGDA as a medical device — the BSTI/PPE route does not cover it. (3) If the product claims BOTH: expect both BSTI and DGDA obligations. COMMON EXPORT MISTAKE: Chinese manufacturers print 'medical' or 'surgical' wording on a KN95 (GB 2626) industrial mask to widen its market; in Bangladesh this pulls the product into the DGDA medical-device route in addition to (or instead of) the BSTI route, and a respirator presented for occupational use must not carry unsubstantiated medical claims. There is no EU-style horizontal regime (no RoHS, no battery regulation, no outdoor-noise directive) to additionally satisfy.[INFORMATIONAL — CRITICAL BOUNDARY] In Bangladesh the mask's intended purpose decides the route: occupational filtering respirators go to BSTI against a BDS standard adopting EN 149 (plus a BSTI CM licence where listed and the labour-law occupational framework), while medical/surgical masks go to DGDA as medical devices. The two routes must not be mixed. Adding 'medical' or 'surgical' wording to a KN95 (GB 2626) industrial mask pulls it into the DGDA route. Bangladesh has no EU-style horizontal regimes (no RoHS, battery, or outdoor-noise rules) to satisfy in addition.	Directorate General of Drug Administration (DGDA), Ministry of Health and Family Welfare, Government of Bangladesh2026-06-15 · reference

INFORMATIONAL ONLY

Informational only / not a certification conclusion

AI-compiled, not human-verified. This comparison is generated and cross-checked by multiple AI models from public official sources; it has not been reviewed by a named human expert and may contain errors or out-of-date items. Confirm every requirement directly with the official regulator or standards body and a qualified professional before relying on it. Nothing here is legal, certification, customs, or market-access advice.

This page is an informational comparison aid, not a certification decision, legal opinion, BSTI conformity assessment, customs determination, or market-access approval. Exporters, importers, and distributors should verify current Bangladesh law, BSTI/BDS standards, the BSTI mandatory certification mark product list, labour-law occupational requirements, and DGDA medical-device classification with qualified regulatory professionals before shipment or placing products on the market. The PPE-vs-medical mask boundary described herein requires case-by-case analysis.

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Bangladesh Standards and Testing Institution (BSTI), Ministry of Industries, Government of Bangladesh · accessed 2026-06-15 · reference · used in 4 rows
ILO NATLEX — Bangladesh Labour Act, 2006 (national legislation database) · accessed 2026-06-15 · reference · used in 1 rows
Directorate General of Drug Administration (DGDA), Ministry of Health and Family Welfare, Government of Bangladesh · accessed 2026-06-15 · reference · used in 1 rows

China-to-Bangladesh PPE Respirator (FFP Mask) Compliance Gap Matrix

Compliance Gap Matrix

Related Compliance Matrices

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Official-source register.