Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly on the human body, including the required computer software; Its utility is mainly obtained through physical methods, not through pharmacology, immunology or metabolism. Although there are these ways to participate, but only play a supporting role; its purpose is:
(1) Diagnosis, prevention, monitoring, treatment or alleviation of diseases;
(2) Diagnosis, monitoring, treatment, mitigation or functional compensation of injury;
(3) Inspection, substitution, adjustment or support of physiological structure or physiological process;
(4) Life support or maintenance;
(5) Pregnancy control;
(6) Provide information for medical or diagnostic purposes by examining samples from the human body.
—— "Regulations on the Supervision and Administration of Medical Devices" (State Council Order No. 650, revised by State Council Order No. 680 in 2017)
According to my country's "Catalog of Medical Devices Classification" issued on August 31, 2017 (State Food and Drug Administration Announcement No. 104 of 2017), medical surgical masks, medical protective masks, and medical nursing masks used in clinical practice are all second Class medical equipment. Article 8 of the "Regulations on the Supervision and Administration of Medical Devices" stipulates that "Class I medical devices shall be subject to product registration management, and Class II and Class III medical devices shall be subject to product registration management." Article 42 stipulates that "imported medical devices shall be medical devices that have been registered or filed in accordance with the provisions of Chapter 2 of these regulations",Therefore, medical masks produced overseas must obtain a medical device registration certificate before they can be imported.
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