Japanese Customs Regulations on the Import of Masks

Japan regulated masks by protection level: ordinary masks cleared freely, higher-grade masks required PMDA filings.

Overview

Japanese customs applied detailed, level-based rules to imported masks. Ordinary disposable masks were largely unregulated, while medical-grade and high-filtration masks fell under Japan's pharmaceutical regime.

Required documents

• Air waybill or bill of lading
• Commercial invoice

Requirements

• Ordinary disposable masks were essentially not regulated under the Japanese Pharmaceutical and Medical Device Act (PMD Act).
• For higher-protection masks such as N95, the importer had to consult Japan's Ministry of Health, Labour and Welfare (MHLW) in advance about whether a special import license was required.
• For personal-use quantities, only the air waybill and invoice were needed for the import declaration.

Individual and company imports

• Individuals faced no restrictions on ordinary medical masks; masks with protection above the N95 level could not be imported casually, because individuals generally lacked the marketing authorization to import them.
• Japanese companies importing from China had to comply with customs requirements; in practice only pharmaceutical companies holding the proper qualifications could clear commercial mask imports smoothly.