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Do disposable medical masks belong to medical devices?

Date:2021-06-22 Hits:464

    Masks are worn every day, but do we know that masks are medical devices? How about the quality standard of masks? Are the masks used guaranteed? Do disposable medical masks belong to medical devices?

    Medical devices are mainly divided into I, II and III categories. This classification is mainly based on the risk of medical devices, so as to ensure the safety and effectiveness of medical devices.

    Class I products only ensure the product specification, and the relative requirements are not too strict.

    Class II products are controlled by the food and drug administration, and the requirements are higher.

    Class III products refer to the products that need to be implanted into the human body to support and sustain life. Because of the potential risks of such products, the approval of the food and Drug Administration will be more stringent. Only the approved medical device products can have the registration certificate.

    But in general, the approval classification of a certain type of medical devices is not very strict. For example, medical masks are generally divided into the first type of products, while in SARS and other periods with high infection rate, they are divided into the second type. This is to ensure that medical masks have a clear isolation effect, rather than simple ordinary masks.

    According to the requirements of the notice on strengthening the supervision of medical masks (sfybx [2009] No. 95), the supervision of the standards adopted by the approved medical masks within the jurisdiction shall be strengthened, and the relevant enterprises shall be strictly required to organize the production according to the national standards, industry standards or registered product standards, and standardize the use instructions and packaging labels, To guide medical institutions and the public to choose appropriate masks according to the purpose of use, so the medical masks at this time belong to class II equipment.

    In addition, medical masks with various ingredients including sterilization, bacteriostasis and antiviral, which are expected to be used for antibacterial and antiviral, are managed according to the third category of medical devices. Relevant enterprises that want to produce the third category of medical masks must apply for registration with the National Bureau according to relevant regulations, and only after obtaining the medical device registration certificate can they produce and sell them.

    Disposable mask can be used in electronic manufacturing industry, dust-free workshop, catering service industry, food processing, school, motorcycle riding, spraying processing, stamping hardware, electroplating, chemical industry, steel, welding ground, health center, handicraft industry, hospital, beauty, pharmaceutical, factory, environmental cleaning, public places and other purposes.

    Disposable masks are divided into disposable two-layer masks, disposable non-woven masks, disposable three-layer masks and disposable activated carbon masks. According to different types of masks, the filtering effect is different, and the application site is also different.

    It should be noted that the main body engaged in the operation of disposable medical masks does not need to record the medical device products, only the business license contains the operation of medical devices, can be engaged in business activities; Of course, if you want to be engaged in the production of disposable medical masks, you need to go through the first-class medical device products and production record.

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