What are the classifications of medical devices?

2024-07-19

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The classification of medical devices includes Class I, Class II and Class III. A class of medical devices are medical devices that are sufficient to ensure their safety and effectiveness through regular management, such as surgical instruments, stethoscopes, medical X-ray films, etc. Class II medical devices are medical devices whose safety and effectiveness should be controlled, such as thermometers, sphygmomanometers, and ECG diagnostic instruments. The third category of medical devices are medical devices that are implanted in the human body, used to support life maintenance or are potentially dangerous to the human body, such as cardiac pacemakers, artificial joints, vascular stents, etc.

In addition, the management category of medical devices has also been adjusted. The management categories of dozens of medical devices have been reduced, some from category III to category II, some from category II to category I, and some products will no longer be managed as medical devices. These changes will directly affect the production and operation of medical devices. For example, after the production enterprise originally has its own products in the third category and is reduced to the second category management, the enterprise will no longer need to go to Beijing or go to the State Administration of Drug Administration for product registration, but only need to register with the Provincial Drug Administration. From the second category to the first category of management, production enterprises are more convenient, products do not need to register, only for the record.

For medical device practitioners, being able to quickly and proficiently master the old and new versions of the medical device classification catalog has become a compulsory course. You can search for "quick check of medical devices" through the intellectual machinery classification website or small program, and conveniently view the medical device data directly on the mobile phone.

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