Since the start of 2026, major mask-importing markets worldwide have rolled out updated customs clearance and certification requirements. The European Union, the United States, Southeast Asia, and the Middle East have all raised their entry barriers. For Chinese mask exporters, staying on top of these regulatory changes and ensuring full product and documentation compliance has become the lifeline of foreign trade.

European Union: New Standard in Effect, MDR Fully Replaces MDD 

In October 2025, the EU officially adopted the new harmonised standard EN 14683:2025 for medical masks, raising requirements for bacterial filtration efficiency and other key metrics. CE certification for masks exported to the EU must now comply with this updated standard. Meanwhile, CE certificates issued under the old MDD directive expired in May 2026, and all masks must be re-certified under the MDR regulation. Packaging must bear a CE-marked traceability QR code and be registered in the Eudamed database.

United States: FDA Updates Import List, N95 Requires 510(k) 

In January 2026, the FDA updated its mask import listing. Medical N95 respirators are Class II devices and require a 510(k) premarket notification and FDA clearance. Exporters must also ensure a timely transition to the new ASTM F2100-26 standard. For non-medical masks, FDA establishment registration is required. Shipments exceeding 5,000 units must be declared to CBP at least three business days in advance. 

Southeast Asia: Thailand Mandates FDA Registration, Vietnam Strengthens Origin & Batch Inspection

Thailand now requires an FDA registration number for all imported masks. Medical masks fall under HS code 30059090, with a 5% tariff plus 7% VAT, and e-commerce platforms already demand that the registration number be displayed on product detail pages. Vietnam requires medical masks to hold DAV certification and to provide a certificate of origin and batch-test reports. All documents must be accompanied by official Vietnamese translations, and packaging must bear origin markings in Vietnamese. 

Middle East: UAE Mandates ESMA Certification and Arabic Packaging 

Effective February 2026, the UAE requires medical masks to obtain ESMA certification and complete MOHAP medical device registration. All packaging must display bilingual information in Arabic and English; shipments without Arabic labeling will be returned. Non-medical protective masks also require ESMA compliance certification.

China Export Compliance: Customs Declaration Must Include Medical Device Registration Number

Under the joint announcement by the Ministry of Commerce, the General Administration of Customs, and the National Medical Products Administration, exported medical supplies must have NMPA qualification and comply with the importing country’s standards. As of January 2026, all exported medical masks must include the “Medical Device Product Registration Certificate Number” on the customs declaration and undergo electronic verification via the “Smart Customs” system. Uncertified exports will be directly seized.

HS Code Declaration Rules: Strict Distinction Between Medical and Non-Medical Masks 

Medical masks (e.g., surgical masks, N95 respirators) fall under medical supply HS codes and require a medical device registration certificate for customs clearance. Non-medical masks fall under textile HS codes such as 63079000 and must be clearly marked as “non-medical” on the declaration. Misclassification may result in fines of 10%-30% of the cargo value or even destruction of the goods.  In light of these global policy upgrades, exporters should ensure their products meet both NMPA registration and destination-country certification requirements, stay current with standard updates, prepare localised documentation and packaging in advance, and accurately classify HS codes to build a solid foundation for international sales through robust compliance capabilities. 

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