01 What is a medical device?
Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents, calibrators, materials and other similar or related items that are directly or indirectly used on the human body, including required computer software; Its effect is mainly obtained by physical means, not pharmacological, immunological or metabolic methods, or although these methods are involved, they only play an auxiliary role. Suitable for:1. Diagnosis, prevention, monitoring, treatment or alleviation of diseases;2. Diagnosis, monitoring, treatment, alleviation or functional compensation of injury;3. Testing, substitution, regulation or support of physiological structure or physiological process;4. Life support or maintenance;6. Provide information for medical or diagnostic purposes by examining samples from the human body.02 What are the categories of medical device products?
The state implements classified management of medical devices according to the degree of risk.The first type is medical devices with a low degree of risk and routine management that can ensure their safety and effectiveness.The second category is medical devices that have a medium risk and need to be strictly controlled and managed to ensure their safety and effectiveness.The third category is medical devices with high risk and need to take special measures to strictly control and manage them to ensure their safety and effectiveness.03 What is the meaning of medical device instructions, labels, and package markings?
Medical device instructions refer to technical documents made by manufacturers and provided to users with products, which can cover the basic information of the safety and effectiveness of the product and be used to guide the correct installation, commissioning, operation, use, maintenance and maintenance.Medical device label refers to the text description, graphics and symbols attached to the medical device or packaging to identify the characteristics of the product.Medical device packaging identification refers to the text description, graphics and symbols marked on the packaging that reflect the main technical characteristics of medical devices.All medical devices sold and used in China shall be accompanied by instructions, labels and packaging labels. For individual simple medical devices, with the consent of the Food and Drug Administration, one or two of the three items of instructions, labels and packaging labels may be omitted, but not all of them.04 What kind of management system does China implement for the production of medical device products?
China implements a product production registration system for medical devices.The production of Class I medical devices shall be reviewed and approved by the drug regulatory department of the people's government at the municipal level divided into districts, and a product production registration certificate shall be issued.The production of Class II medical devices shall be reviewed and approved by the drug regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government, and a product production registration certificate shall be issued.The production of Class III medical devices shall be reviewed and approved by the drug regulatory department of the State Council, and a product production registration certificate shall be issued.05 What qualifications do I need to operate medical device products?
The establishment of a Class I medical device business enterprise shall be filed with the drug regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government. The establishment of Class II and Class III medical device business enterprises shall be reviewed and approved by the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, and the "Medical Device Business Enterprise License" shall be issued. Without the "Medical Device Business Enterprise License", the administrative department for industry and commerce shall not issue a business license.
06 What are the requirements for medical device advertising?
Advertisements for medical devices shall be reviewed and approved by the drug regulatory department of the people's government at or above the provincial level; Without approval, it must not be published, broadcast, distributed or posted.The content of medical device advertisements shall be subject to the instructions for use approved by the drug regulatory department of the State Council or the drug regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government.07 Do medical devices need to go through clinical trials before they go to market?
Clinical trials of medical devices are divided into clinical trials of medical devices and clinical validation of medical devices.For medical devices that have not yet appeared on the market and whose safety and effectiveness have yet to be confirmed, clinical trial studies of medical devices are required before approval for marketing.For medical devices whose safety and effectiveness need to be further confirmed after similar products have been marketed, clinical verification studies of medical devices are required before approval for marketing.08 What are the common household medical devices?
1. Household treatment instrumentsSuch as far-infrared therapy instrument, magnetic therapy instrument, physiotherapy instrument, low and medium frequency therapy instrument, medical compression nebulizer, etc.2. Household testing equipmentSuch as electronic sphygmomanometers, blood glucose meters, electronic thermometers, stethoscopes, etc.3. Household medical rehabilitation appliancesSuch as household oxygen concentrators, cervical and lumbar traction devices, orthoses, anti-pressure ulcer mattresses, wheelchairs, etc.4. Personal protective medical equipmentSuch as disposable medical masks, medical surgical masks, medical protective masks, medical isolation masks, etc.09 What are the contents of the medical device instructions?
The instructions for medical devices shall generally include the following:
1. Product name, model and specification;
2. The name of the manufacturer, registered address, production address, contact information and after-sales service unit;
3. The number of the "Medical Device Manufacturing Enterprise License" (except for Class I medical devices) and the number of the medical device registration certificate; Product standard number;
4. The performance, main structure and scope of application of the product;
5. Contraindications, precautions and other contents that need to be warned or prompted; Explanation of graphics, symbols, abbreviations and other contents used in medical device labels;
6. Installation and use instructions or diagrams;
7. Product maintenance and maintenance methods, special storage conditions and methods;
8. Products that are used within a limited period shall be marked with the expiration date;
9. Other contents specified in the product standard shall be indicated in the manual.
10 What must not be included in the medical device instructions?
The instructions for medical devices shall not contain the following:
1. Contains assertions or guarantees of efficacy, such as "the best curative effect", "guaranteed cure", "guaranteed cure", "cure", "immediate effect", "no toxic side effects at all", etc.;
2. Contains absolute language and expressions such as "the highest technology", "the most scientific", "the most advanced", and "the best";
3. Explain the cure rate or effective rate;
4. Compare the efficacy and safety of products from other enterprises;
5. Contains promising language such as "insurance company insurance" and "invalid refund";
6. Using the name or image of any unit or individual as proof or recommendation;
7. Contains expressions that make people feel that they have suffered from a certain disease, or that make people misunderstand that they will suffer from a certain disease or aggravate the condition if they do not use the medical device;
8. Other content prohibited by laws and regulations.
苏公网安备32011802010375号
