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Disposable cleanroom garments:Chinese medical protective clothing standards

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Disposable cleanroom garments:Chinese medical protective clothing standards


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In China, medical devices are usually divided into three categories based on risk: first, those with low risk and basically no risk belong to the first category, which shall be filed with the drug regulatory department of local and municipal bureaus. Second, medium risk medical devices shall be registered and approved by the drug regulatory department at the provincial level. Third, high-risk medical devices belong to three categories, and the National Bureau is directly responsible for organizing the examination and approval.


Medical protective clothing belongs to class II medical devices, which shall be registered and managed by the provincial drug regulatory department


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