What are the medical device regulations

Medical device regulations are "medical device standards management measures", "large-scale medical equipment configuration and use of management methods", "medical device recall management methods", "medical device use quality supervision and management methods" and other laws and regulations. China's relevant laws and regulations, can not be illegal to operate medical devices and their supervision and management.

What is the classification of medical devices

Medical devices are categorized as follows:

1, the first class is a low risk, the implementation of routine processing can ensure its safety, useful medical devices. The implementation of the product record processing, by the municipal food and drug supervision and management department in charge of the approval, issuance of certificates of registration;

2, the second class is the safety and usefulness of medical devices should be manipulated. The second class is a moderate risk, the need for strict control to ensure its safety and usefulness of medical devices. Implementation of product registration and processing by the provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration department in charge of the approval, issuance of certificates of registration;

3, the third category is implanted in the human body, used to support, maintain life, the human body has a potential risk to its safety, usefulness of medical devices need to be strictly controlled.

Legal basis: "Chinese people's *** and the basic medical care and health promotion law" Article 99

Violation of the provisions of this law, without obtaining a license to practice medical institutions without authorization to practice, by the competent departments of the people's government at or above the county level of health ordered to stop practicing, confiscate the illegal income and medicines, medical equipment, and impose more than five times the illegal income of twenty times the following fine, and if the illegal income is less than ten thousand yuan, it shall be calculated at ten thousand yuan.

In violation of the provisions of this Law, forging, altering, trading, leasing, lending medical institution practice license, the competent department of health care of the people's government at or above the county level shall order correction, confiscate the illegal income, and impose a fine of not less than five times but not more than fifteen times the illegal income, and if the illegal income is less than ten thousand yuan, it shall be calculated according to ten thousand yuan; in case of seriousness of the situation, the license to practice in a medical institution shall be revoked.