CROSS-STANDARD public interest · PPE / respirator (mask)
China-to-Philippines 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 / GB 19083) documentation against Philippine requirements: the DOLE (Department of Labor and Employment) occupational safety and health framework for respiratory protection at work, PNS (Philippine National Standards) respirator standards, the Bureau of Philippine Standards (BPS) under DTI where a technical regulation applies, the FDA for medical / surgical masks, and the in-country importer obligation.
Dataset 2026-06-11
Last verified 2026-06-15
6 rows
GAP MATRIX
Compliance Gap Matrix
| Compliance item | Common China baseline | Philippines (BPS / DTI) | Gap / action | Source + verification date |
|---|---|---|---|---|
| Conformity Assessment — Respirator Market Access (DOLE OSH + PNS + BPS / ICC where applicable) | 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), involving type testing by a CNAS-accredited laboratory plus factory inspection. For medical-protective masks (GB 19083), NMPA registration is required as a medical device (commonly Class II). Neither the CCC scheme nor the NMPA medical device registration is automatically recognised by Philippine authorities — DOLE accepts conformity to PNS or a recognised international standard, BPS issues its own PS/ICC against PNS, and the FDA conducts its own medical device assessment.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) |
The Philippines does not operate a single notified-body type-examination scheme equivalent to the EU. Respirator market access runs through several overlapping routes. (1) OCCUPATIONAL ROUTE: Under Republic Act 11058 and its implementing rules DOLE Department Order 198-18, employers must provide respiratory protective equipment that conforms to recognised standards; PPE is to comply with the relevant Philippine National Standard (PNS) or an equivalent recognised international standard accepted by DOLE. (2) PRODUCT CERTIFICATION ROUTE: Where a product is covered by a mandatory Philippine technical regulation, the Bureau of Philippine Standards (BPS) under the DTI administers certification — a Philippine Standard (PS) Quality and/or Safety Certification Mark for locally manufactured goods, or an Import Commodity Clearance (ICC) for imported goods, each issued against the applicable PNS. (3) MEDICAL ROUTE: If the product is a medical or surgical mask, the FDA regulates it as a medical device, separate from the PPE route. An in-country importer of record is required to clear and place the goods. Conformity is therefore demonstrated by meeting the applicable PNS / recognised standard, holding any required ICC, and (for medical masks) FDA registration — rather than by a single mandatory third-party certificate for all respirators.Republic Act No. 11058 — An Act Strengthening Compliance with Occupational Safety and Health Standards (and Rule on PPE provision by employers) DOLE Department Order No. 198-18 — Implementing Rules and Regulations of RA 11058 (employer duty to provide standards-compliant PPE) DTI / Bureau of Philippine Standards (BPS) — PS Quality/Safety Certification Mark (local manufacture) and Import Commodity Clearance (ICC) scheme for products under a mandatory technical regulation FDA Philippines — medical device regulation for medical / surgical masks (separate from the PPE route) |
The exporter must establish the correct Philippine route before shipment. Specific gaps: (1) determine whether the product is occupational PPE (DOLE/PNS route) or a medical/surgical mask (FDA route) — the claim on the label decides this; (2) Chinese CCC certificates and NMPA registrations do not substitute for the applicable PNS conformity or any required BPS ICC; (3) an in-country importer of record must be appointed to clear customs and place the product; (4) if a mandatory technical regulation applies to the respirator category, an Import Commodity Clearance (ICC) from BPS must be obtained per consignment / model against the relevant PNS; (5) for medical masks, FDA medical device registration and a licensed importer/distributor are required; (6) DOLE will expect product documentation (test reports to PNS or a recognised standard such as the relevant ISO/EN/NIOSH reference) demonstrating the respirator's protection class.[INFORMATIONAL] Philippine respirator market access is route-dependent: occupational respirators run through the DOLE OSH framework (RA 11058 / DO 198-18) and PNS conformity, with a BPS Import Commodity Clearance (ICC) where a mandatory technical regulation applies; medical and surgical masks run through the FDA as medical devices. Chinese CCC or NMPA certifications are not automatically recognised. Exporters must classify the product correctly, appoint an in-country importer of record, and meet the applicable PNS / FDA requirement before placement. | Bureau of Philippine Standards (BPS), Department of Trade and Industry (DTI)2026-06-15 · reference |
| Product Labelling and Information Requirements — Respirators for the Philippine Market | GB 2626-2019 Clause 7 specifies Chinese marking for non-powered air-purifying particle respirators: manufacturer name or trademark, product name, model, standard number (GB 2626-2019), performance class (KN90 or KN95), and NR/R designation on the product, with manufacturer details, production date and shelf life, lot number, storage conditions and Chinese-language instructions on the packaging, plus the CCC mark. Medical masks (GB 19083 / YY 0469) carry NMPA medical device labelling in Chinese. Key differences from the Philippine expectation: Chinese labelling is in Chinese (the Philippines works in English and requires importer/country-of-origin disclosure, and FDA references for medical masks), the CCC mark is not the Philippine conformity mark, and the standard cited (GB) differs from the recognised PNS/N95/FFP references.GB 2626-2019 — Clause 7 (Marking and packaging requirements) China CCC (3C) mark — mandatory product certification mark on product and packaging GB 19083-2010 / YY 0469-2011 — NMPA medical device labelling for medical masks |
Labelling expectations in the Philippines follow the route the product takes. (1) OCCUPATIONAL PPE: The respirator should be marked with the manufacturer name or trademark, the model/type, the standard and protection class it is certified to (e.g., N95 / FFP2 / the relevant PNS class), and reusable/single-use status, with instructions for use covering donning, fit-check, limitations, and storage. English is the practical working language of Philippine commerce and regulation, so instructions and key markings should be available in English. Where a mandatory technical regulation applies, the BPS PS/ICC mark and the importer's details should appear per the ICC requirements. (2) GENERAL CONSUMER GOODS RULES: Imported consumer goods must carry the importer's name and address and country of origin under DTI fair-trade/consumer labelling rules. (3) MEDICAL / SURGICAL MASKS: Labelling must support the FDA medical device registration — including the FDA registration/notification reference, the manufacturer and the FDA-licensed importer/distributor, the device description, lot number and expiry, and instructions in English. Misleading claims (e.g., calling an industrial respirator 'surgical' without FDA registration) are an enforcement risk.Republic Act No. 7394 — Consumer Act of the Philippines (consumer product labelling, importer and country-of-origin disclosure, DTI enforcement) DTI / Bureau of Philippine Standards (BPS) — PS/ICC marking requirements where a mandatory technical regulation applies Republic Act No. 9711 and FDA Philippines — medical device labelling for medical / surgical masks (FDA registration reference, licensed importer, lot/expiry, English instructions) |
Typical labelling gaps for Chinese manufacturers entering the Philippines: (1) LANGUAGE: Chinese-only markings and instructions are not adequate — English markings and instructions for use are expected for commerce, regulation, and end-user safety. (2) IMPORTER / ORIGIN DISCLOSURE: the importer's name and address and country of origin must appear under the Consumer Act (RA 7394); a Chinese export label without a Philippine importer block is non-compliant. (3) CONFORMITY MARK: the CCC mark should not be presented as Philippine conformity; where ICC applies, the BPS/ICC requirements govern marking. (4) STANDARD/CLASS CLAIM: the protection class should be expressed against the recognised standard the importer accepts (N95/FFP2/PNS), not only 'KN95 / GB 2626'; labelling a product 'KN95' while selling it as 'N95' or 'FFP2' is misleading. (5) MEDICAL CLAIMS: if 'medical'/'surgical' wording is used, the label must carry the FDA registration reference and licensed-importer details; using such wording without FDA registration is an enforcement risk under RA 9711. (6) LOT/EXPIRY: clear lot number and (for medical masks) expiry date should be shown for traceability.[INFORMATIONAL] Respirator labelling for the Philippine market requires English markings and instructions, importer name/address and country-of-origin disclosure under the Consumer Act (RA 7394), the protection class expressed against the recognised standard the importer accepts (N95/FFP2/PNS), and — where applicable — BPS/ICC marking. Medical/surgical masks additionally require FDA medical device labelling (registration reference, licensed importer, lot/expiry). Chinese-only labels, the CCC mark, and 'KN95 / GB 2626' as the sole class claim do not satisfy these requirements; medical wording without FDA registration is an enforcement risk. | Department of Trade and Industry (DTI), Philippines — Consumer Protection2026-06-15 · reference |
| Conformity Marks, Importer of Record, and FDA Registration — Placing a Respirator on the Philippine Market | China does not use CE or PS/ICC marks. Domestic conformity is shown by the CCC mark (mandatory for GB 2626 industrial respirators), affixed after certification by a CNCA-authorised body, or by NMPA registration (for GB 19083 / YY 0469 medical masks). There is no requirement equivalent to a Philippine importer of record or FDA LTO for the Chinese domestic conformity pathway, and the CCC mark / NMPA registration documents are not accepted by Philippine authorities (BPS or FDA) as evidence of Philippine 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 under drug/device law |
Unlike the EU CE-marking system, the Philippines does not apply a single conformity mark to all respirators; the marks and registrations depend on the route. (1) PRODUCT CERTIFICATION MARK (BPS / DTI): Where a respirator category is covered by a mandatory Philippine technical regulation, the product carries the Philippine Standard (PS) Quality and/or Safety Certification Mark (for goods manufactured in the Philippines) or is cleared under an Import Commodity Clearance (ICC) sticker for imported goods, each issued by the Bureau of Philippine Standards against the applicable PNS. (2) IMPORTER OF RECORD: An in-country importer must be the importer of record to clear the goods through the Bureau of Customs and to bear product-responsibility obligations domestically. (3) FDA REGISTRATION (medical/surgical masks): A medical or surgical mask must hold the appropriate FDA medical device registration/notification and be imported/distributed by an FDA-licensed establishment (License to Operate). The relevant identifier here is the FDA registration/notification number and the importer's LTO, not a CE/NB number. There is no Philippine equivalent of the EU Authorised Representative; the in-country importer (and, for medical devices, the FDA-licensed establishment) carries the local responsibility.DTI / Bureau of Philippine Standards (BPS) — Philippine Standard (PS) Certification Mark and Import Commodity Clearance (ICC) scheme Bureau of Customs — importer of record requirement for clearance of imported goods Republic Act No. 9711 and FDA Philippines — medical device registration/notification and License to Operate (LTO) for medical/surgical masks |
Distinct gaps must be closed depending on route: (1) APPOINT AN IMPORTER OF RECORD: a Philippine-established importer must clear the goods and bear domestic product responsibility; Chinese manufacturers cannot place product directly without one. (2) BPS ICC (where applicable): if a mandatory technical regulation covers the respirator, an Import Commodity Clearance against the relevant PNS must be obtained, typically per shipment/model; the Chinese CCC mark does not satisfy this. (3) FDA REGISTRATION (medical/surgical masks): obtain the FDA medical device registration/notification and ensure the importer/distributor holds an LTO; NMPA registration is not accepted. (4) MARK/NUMBER ON PRODUCT: where ICC or FDA applies, the corresponding clearance/registration must be in place and traceable — the Chinese CCC mark should not be presented as the Philippine conformity mark. (5) NO EU AUTHORISED REP, BUT a local responsible party (importer / FDA-licensed establishment) is mandatory and must be documented.[INFORMATIONAL] The Philippines has no single CE-style mark for respirators. Placement requires an in-country importer of record; a BPS Import Commodity Clearance (ICC) against the relevant PNS where a mandatory technical regulation applies; and, for medical/surgical masks, FDA medical device registration plus an FDA-licensed importer (LTO). Chinese CCC marks and NMPA registrations are not accepted as Philippine conformity evidence. There is no EU-style Authorised Representative, but a documented local responsible party (importer / FDA-licensed establishment) is mandatory. | Bureau of Philippine Standards (BPS), Department of Trade and Industry (DTI)2026-06-15 · reference |
| Filtering Respirator Safety — PNS / Recognised Standard Performance Requirements (Occupational PPE) | China's primary standard for non-powered air-purifying particle respirators is GB 2626-2019, 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. Key differences from the recognised Philippine references: GB 2626 uses sodium chloride (NaCl) aerosol only (EN 149 uses both NaCl and paraffin oil; NIOSH uses NaCl for N-series), and the test conditions, headform, and fit/total-inward-leakage protocols differ. A KN95 test report to GB 2626 demonstrates a comparable filtration class but is not automatically equivalent to an N95 (NIOSH) or FFP2 (EN 149) certificate; Philippine importers and safety officers typically request a report to the recognised standard they accept.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 use — not industrial PPE) |
Respiratory protective equipment used at work in the Philippines must perform to a recognised standard accepted under the DOLE occupational safety and health framework (RA 11058 / DOLE Department Order 198-18), which obliges employers to select and provide PPE adequate to the assessed respiratory hazard. Conformity is referenced to the applicable Philippine National Standard (PNS) for respiratory protective devices, or to a recognised international standard widely accepted in Philippine practice — most commonly NIOSH 42 CFR Part 84 (N95/N99/N100), EN 149:2001+A1:2009 (FFP1/FFP2/FFP3), or the relevant ISO respirator standard. Performance expectations cover filtration efficiency against particulate aerosols, total inward leakage / fit, breathing resistance (inhalation and exhalation), and where applicable CO2 build-up and practical wear. Because the Philippines frequently recognises N95 and FFP marks for occupational use, the exporter should present test reports to whichever recognised standard the importer and end-user (e.g., a hospital, mine, or factory safety officer) require, with the protection class clearly evidenced.Republic Act No. 11058 and DOLE Department Order No. 198-18 — employer duty to provide respiratory PPE adequate to the assessed hazard Philippine National Standards (PNS) for respiratory protective devices (BPS-adopted) Recognised international references commonly accepted: NIOSH 42 CFR Part 84 (N95), EN 149:2001+A1:2009 (FFP), and relevant ISO respirator standards |
Exporters should align their test evidence with the recognised standard the Philippine importer/end-user accepts (commonly N95 NIOSH or FFP2 EN 149) rather than relying on the GB 2626 KN95 report alone. Specific gaps: (1) GB 2626 KN95 reports use NaCl-only aerosol and a different fit/total-inward-leakage protocol, so they do not by themselves satisfy an EN 149 or NIOSH dossier; (2) where the importer requires PNS conformity, a test report mapped to the relevant PNS respirator standard is needed; (3) the protection class (filtration efficiency and fit) must be clearly evidenced for the DOLE hazard-based selection by the employer; (4) if a mandatory technical regulation applies to the respirator category, a BPS Import Commodity Clearance against the relevant PNS is required in addition to the test evidence; (5) reports should come from an accredited laboratory whose scope the Philippine importer can rely on.[INFORMATIONAL] Occupational respirators for the Philippine market should be evidenced against the recognised standard the importer and end-user accept (commonly N95 NIOSH or FFP2 EN 149) and the applicable PNS, satisfying the DOLE OSH duty to provide hazard-adequate PPE. A Chinese GB 2626-2019 (KN95) report demonstrates a comparable filtration class but is not automatically equivalent; align the dossier with the recognised standard required, and obtain a BPS ICC where a mandatory technical regulation applies. | Department of Labor and Employment (DOLE), Philippines2026-06-15 · reference |
| Medical / Surgical Mask Safety — FDA Medical Device Route (Not the Occupational PPE 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, and is enforced by NMPA as a Class II medical device. YY 0469-2011 covers medical surgical masks (bacterial filtration efficiency, particle filtration, splash resistance), also an NMPA Class II medical device. In China these medical masks are regulated as devices, not as GB 2626 industrial PPE. The Philippine equivalent route is the FDA medical device pathway (FDA registration plus a licensed importer/distributor); the Chinese NMPA registration is not automatically recognised by the FDA Philippines.GB 19083-2010 — Technical requirements for medical protective mask (NMPA Class II medical device) YY 0469-2011 — Medical surgical mask — Technical requirements (NMPA Class II medical device) |
Where a mask is intended for medical or surgical use, it is regulated in the Philippines as a medical device by the FDA under RA 9711 (FDA Act of 2009) and the medical device licensing/registration rules, not as occupational PPE under DOLE. Medical masks reference the applicable PNS for medical face masks (covering bacterial filtration efficiency, breathability/differential pressure, splash resistance and microbial cleanliness), with PNS / ASTM F2100 / EN 14683 commonly used as the technical basis. The supply chain must include an FDA-licensed importer or distributor (License to Operate), and the specific device must hold the appropriate FDA registration or notification before sale. Medical-protective respirators of the GB 19083 type, which combine a particle-filtration function with medical splash protection, would in Philippine terms sit in the FDA medical device route if marketed for clinical use, and additionally need to satisfy occupational respirator expectations if also relied on as worker PPE.Republic Act No. 9711 — Food and Drug Administration Act of 2009 (FDA medical device authority) FDA Philippines medical device registration / notification and License to Operate (LTO) for importer/distributor Philippine National Standard for medical face masks (BPS-adopted); ASTM F2100 / EN 14683 commonly used as technical basis |
Chinese GB 19083 / YY 0469 NMPA registration has no automatic recognition in the Philippines. To place a medical or surgical mask on the Philippine market: (1) appoint an FDA-licensed importer or distributor holding a valid License to Operate (LTO); (2) obtain the appropriate FDA medical device registration / notification for the specific product; (3) provide test evidence to the applicable PNS for medical face masks or a recognised basis (ASTM F2100 / EN 14683) covering bacterial filtration efficiency, differential pressure, and splash resistance; (4) if the same product is also relied upon as occupational worker PPE, additionally evidence the occupational respirator class under the DOLE/PNS route. Selling a 'medical' or 'surgical' labelled mask without FDA registration is an enforcement risk under RA 9711.[INFORMATIONAL] Medical and surgical masks (the GB 19083 / YY 0469 family) are regulated in the Philippines by the FDA as medical devices under RA 9711, requiring FDA registration and an FDA-licensed importer/distributor — the Chinese NMPA registration is not automatically recognised. This is a separate route from the DOLE/PNS occupational respirator pathway; choose the correct route based on the product's intended-use claim, and satisfy both routes only if both worker and medical protection are claimed. | Food and Drug Administration (FDA) Philippines2026-06-15 · reference |
| CRITICAL BOUNDARY: Occupational PPE Respirator vs. Medical / Surgical Mask — Which Philippine Authority 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 highly infectious environments, administered by NMPA as a Class II medical device; (3) SURGICAL MASK: YY 0469-2011 (Medical surgical mask — Technical requirements) — for surgical use, NMPA Class II medical device. The Chinese three-track system maps to the Philippine split: GB 2626 industrial respirators correspond to the DOLE/PNS occupational PPE route, while GB 19083 and YY 0469 medical masks correspond to the FDA medical device route. The mapping is not 1:1 — KN95 (GB 2626) is not identical to N95 (NIOSH) or FFP2 (EN 149) because test methods differ, even though all three are commonly referenced for occupational respirators in the Philippines.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 the Philippines the regulatory home of a face mask depends on its INTENDED PURPOSE, just as the EU splits PPE from medical devices. (A) OCCUPATIONAL / PARTICLE RESPIRATOR (PPE ROUTE): A product intended to protect the WEARER against airborne particles, dusts, or aerosols at work falls under the DOLE occupational safety and health framework (RA 11058 and DOLE Department Order 198-18), with conformity referenced to the applicable Philippine National Standard (PNS) or a recognised international standard (e.g., the relevant ISO/EN respirator standard or NIOSH 42 CFR Part 84 for N95). Where a mandatory technical regulation covers the category, the BPS (DTI) PS/ICC scheme applies. (B) MEDICAL / SURGICAL MASK (FDA / MEDICAL DEVICE ROUTE): A product intended to protect the PATIENT or ENVIRONMENT from the wearer's respiratory emissions, or marketed for clinical/medical use, is a medical device regulated by the FDA (Food and Drug Administration) of the Philippines under RA 9711 (FDA Act) and the medical device licensing rules. PNS reference standards exist for medical face masks. (C) DUAL-CLAIM PRODUCTS: A product that claims BOTH worker particle protection AND a medical/surgical function must satisfy BOTH the DOLE/PNS PPE expectations AND FDA medical device registration. Mislabelling an occupational KN95-type respirator with surgical/medical wording pulls it into FDA jurisdiction it has not satisfied.Republic Act No. 11058 and DOLE Department Order No. 198-18 — occupational safety and health; employer duty to provide standards-compliant respiratory PPE (PPE route) Republic Act No. 9711 — Food and Drug Administration Act of 2009; FDA medical device regulation for medical / surgical masks (medical device route) Philippine National Standards (PNS) — respirator and medical face mask reference standards adopted by BPS Recognised international respirator references commonly accepted for occupational PPE (e.g., NIOSH 42 CFR Part 84 N95, EN 149 FFP, relevant ISO standards) |
The single most important decision is what the product label and instructions claim. (1) If the product claims WEARER PROTECTION against particles for occupational use: the DOLE/PNS PPE route applies; documentation should reference the applicable PNS or a recognised respirator standard (N95/FFP/ISO), and a BPS ICC is needed if a mandatory technical regulation covers the category. (2) If the product claims MEDICAL / SURGICAL use or protection of the patient/environment: the FDA medical device route applies, requiring FDA registration and a licensed importer. (3) If the product claims BOTH: both routes apply. COMMON EXPORT MISTAKE: Chinese manufacturers print 'surgical' or 'medical' wording on KN95 (GB 2626) industrial masks to widen the market; in the Philippines that wording brings the product under FDA medical device jurisdiction, and selling it without FDA registration exposes the importer to enforcement, seizure, and penalties under RA 9711.[INFORMATIONAL — CRITICAL BOUNDARY] In the Philippines, occupational particle respirators are PPE governed by the DOLE OSH framework and PNS (BPS/ICC where a technical regulation applies), while medical and surgical masks are medical devices regulated by the FDA under RA 9711. The two routes must not be mixed. A Chinese KN95 (GB 2626) industrial respirator should follow the occupational PPE route; adding 'surgical' or 'medical' wording triggers FDA medical device registration that is frequently absent, exposing importers to seizure and penalties. | Food and Drug Administration (FDA) Philippines2026-06-15 · reference |
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SOURCES
Official-source register.
- Bureau of Philippine Standards (BPS), Department of Trade and Industry (DTI) · accessed 2026-06-15 · reference · used in 1 rows
- Department of Trade and Industry (DTI), Philippines — Consumer Protection · accessed 2026-06-15 · reference · used in 1 rows
- Bureau of Philippine Standards (BPS), Department of Trade and Industry (DTI) · accessed 2026-06-15 · reference · used in 1 rows
- Department of Labor and Employment (DOLE), Philippines · accessed 2026-06-15 · reference · used in 1 rows
- Food and Drug Administration (FDA) Philippines · accessed 2026-06-15 · reference · used in 1 rows
- Food and Drug Administration (FDA) Philippines · accessed 2026-06-15 · reference · used in 1 rows