Taiwan amends regulatory requirements for registration of medical masks

Taiwan Food and Drug Administration (TFDA) has amended regulatory requirements for the registration of medical masks. 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 abovementioned 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 submicron 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 colourants, formaldehyde and migratable fluorescent substances, are reported to be hazardous to human health. To minimise the impact of such additives to human health, TFDA requires applicants who apply for the registration of coloured or dyed medical masks to provide relevant evidence to prove that the products to be registered meet the quality requirements for coloured or dyed medical masks of CNS 14774.