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Taiwan: Essential Insights into Medical Mask Registration Requirements (15 March 2023)

Updated: Apr 16

Following the amendment for the Medical Mask (CNS 14774 (T5017)) and Disposable Dust Respirators (CNS 14755 (Z2125)) under the classification of I.4040 for Medical Apparel, Taiwan Food and Drug Administration (TFDA) revised the “Regulations Governing the Classification of Medical Devices” to align the regulatory requirements understanding for manufacturers or concerned applicants.

Medical Mask, “D2 Class Medical Mask” stated under the above National Standards was replaced with “TN95 Medical Mask”. All medical masks with TN95 or N95 claimed, have to ensure the sub-micron particulate filtration and exhalation/inhalation resistance of airflow must be equivalent to the TN95’s performance requirements with the disposable dust respirators (CNS 14755 (Z2125)).

Applicants for coloured or dyed medical mask registration are also required to submit evidence proving that their products comply with the quality requirements of CNS 14774, apart from test reports or certificates from competent authorities, qualified laboratories, or, international organizations as proof of claim that their products also complying the specific international or national standards.

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