1, what is the second kind of medical devices?
Medical device registration refers to the process of systematically evaluating the safety and effectiveness of medical devices to be marketed and used in accordance with legal procedures to decide whether to approve their sale and use. Divided into domestic medical device registration and overseas medical device registration. Overseas medical devices, whether Class I, Class II or Class III, must be handled by the State Food and Drug Administration of Beijing; domestic medical devices of Class I and Class II shall be handled by the local provincial or municipal food and drug administration, and medical devices of Class III shall be handled by the State Food and Drug Administration. Medical device registration certificate refers to the legal identity card of medical device products.
The second category of medical devices refers to medical devices whose safety and effectiveness should be controlled.
Article 30 of the Regulations on the Supervision and Administration of Medical Devices stipulates that those who engage in the operation of Class II medical devices shall file with the food and drug supervision and administration department of the municipal people's government with districts, and submit certification materials that meet the conditions stipulated in Article 29 of these regulations.
Article 29 of the Regulations on the Supervision and Administration of Medical Devices stipulates: To engage in business activities of medical devices, there should be business premises and storage conditions suitable for the scale and scope of business, as well as quality management systems and quality management institutions or personnel suitable for the medical devices operated.
Jiuboshi smokeless moxa stick
2. What brand of smokeless moxa sticks is registered as hospital equipment?
At present, there are few brands of smokeless moxa sticks with medical device registration certificate on the market, and Dr. Moxibustion smokeless moxa sticks are one of the few brands that have obtained medical device registration certificate. Dr. Moxibustion's smokeless moxa stick not only has the second-class medical device product registration certificate (certificate number 20 192200399), but also has the medical device production license (certificate number 20 150065438+).