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Regulatory Requirements for the Registration of Medical Masks

【Update Date:2024-03-15unit:醫療器材及化粧品組

Taiwan Food and Drug Administration (TFDA) amended regulatory requirements for the registration of medical masks in 2023. The “Regulations Governing the Classification of Medical Devices” was amended to change the content in the identification in the classification of I.4040 “Medical apparel” following the amendment of National Standard CNS 14774 (T5017)- Medical face mask and CNS 14755(Z2125)- Disposable dust respirators. With the amendment of the above-mentioned National Standards, “D2 class medical mask” was replaced with “TN95 medical mask”. Moreover, for medical masks labelled/claimed to have the equivalent or above effect of TN95 or N95, the sub-micron particulate filtration and exhalation/inhalation resistance of airflow of the mask should be in accordance with TN95 (or higher) performance requirements from disposable dust respirators of the National Standard CNS 14755 (Z2125).

Some additives of medical masks, such as some azo colorants, formaldehyde and migratable fluorescent substances, are reported to be hazardous to human health. To minimize the impact of such additives to human health, TFDA requires applicants who apply for the registration of colored or dyed medical masks to provide relevant evidence to prove that the products to be registered meet the quality requirements for colored or dyed medical masks of CNS 14774.

Moreover, according to the amended “Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration” in 2023, if the applicants submit the medical masks labeled/claimed to meet performance requirements of specific international or national standards, such as N95 or FFP2, they should submit the test reports or certificates from the competent authorities, qualified laboratory or international organizations, to prove their claims.

The amendments helped to make regulatory management of medical masks more comprehensive and it is recommended that medical device manufacturers or applicants understand relevant requirements before applying to facilitate product development and subsequent registration procedures.