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用途:消字号产品主要用于外用卫生消毒,检测指标主要为抑菌、杀菌作用,不具备调节人体生理功能的功效,不能出现或暗示治疗效果。常见的消字号产品包括漱口水、妇科抑菌凝胶、抑菌粉、抑菌液、妇科洗液、止痒膏、痔疮膏、口腔溃疡喷剂、香皂、除臭剂、脚气膏、洗衣液、卫生巾等。械字号产品则是医疗器械,直接或间接用于人体,主要用于疾病的诊断、预防、监护、治疗或缓解,如医用敷料、医用冷敷贴、医用凝胶等。
Usage: Disinfectant products are mainly used for external hygiene and disinfection. The testing indicators are mainly antibacterial and bactericidal effects, and do not have the effect of regulating human physiological functions. They cannot show or imply therapeutic effects. Common Xiaozi products include mouthwash, gynecological antibacterial gel, antibacterial powder, antibacterial liquid, gynecological lotion, antipruritic cream, hemorrhoid cream, oral ulcer spray, soap, deodorant, foot gas cream, laundry detergent, sanitary napkin, etc. Mechanical products are medical devices, which are directly or indirectly used in the human body, mainly for the diagnosis, prevention, monitoring, treatment or relief of diseases, such as medical dressings, medical cold packs, medical gel, etc.
申报主体:消字号的申报主体只需经营范围包含“消毒用品销售”即可;而械字号除了经营范围包含以外,还需要有厂房并具备相对应的生产许可证,普通的公司不具备申请的资格。
Declaration subject: The declaration subject of the disinfection name only needs to have a business scope that includes "sales of disinfection products"; In addition to the scope of business, the equipment brand also needs to have a factory and corresponding production license, and ordinary companies do not have the qualification to apply.
作用方式:消字号产品通过化学方式对人体或物体、空气等产生作用,通常含有植物或化学成分。械字号产品则通过物理方式产生作用,不含有植物或药物等成分。
Mode of action: Disinfected products have a chemical effect on the human body, objects, air, etc., usually containing plants or chemical components. The equipment brand products are produced through physical means and do not contain ingredients such as plants or drugs.
监管要求:消字号产品需经过检测、整理申报材料、申请初审和终审等程序。械字号产品的生产车间必须有专门的净化车间,并通过医疗器械专用体系认证,需经过国家食品药品监督管理局备案等要求。
Regulatory requirements: Anti brand products must undergo testing, sorting of application materials, initial and final review procedures. The production workshop of equipment brand products must have a dedicated purification workshop and be certified by the medical device special system, and must go through requirements such as filing with the National Food and Drug Administration.
消字号和械字号的定义:
The definitions of disinfection number and equipment number:
消字号:属于卫生消毒用品范畴,检测指标主要为抑菌、杀菌作用。其原料需符合中国药典和化妆品要求,只能用于外用消毒杀菌,不具备调节人体生理功能的功效。
Disinfectant name: belongs to the category of hygiene and disinfection products, and the main testing indicators are antibacterial and bactericidal effects. Its raw materials must comply with the requirements of the Chinese Pharmacopoeia and cosmetics, and can only be used for external disinfection and sterilization. It does not have the effect of regulating human physiological functions.
械字号:指医疗器械,直接或间接用于人体的仪器、设备、器具等。其效用主要通过物理方式获得,目的是疾病的诊断、预防、监护、治疗或缓解
Equipment number: Refers to medical devices, instruments, equipment, appliances, etc. directly or indirectly used for the human body. Its utility is mainly obtained through physical means, with the aim of diagnosing, preventing, monitoring, treating, or alleviating diseases
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