Beijing Business Daily (Reporter Yao Qian) On February 4, a reporter from Beijing Business Daily learned that radio frequency instruments and radio frequency instruments will be included in the management of the third class of medical devices from April 1.
Li Ting, director of the technical regulation department of the Guangdong Research Institute of new biomaterials and high-end medical devices, said that there are some differences in the supervision of radio frequency beauty products in the world, and the United States will supervise household radio frequency beauty products according to class II medical devices; The European Union classifies it as a Class IIA (Class II medical device with the same level of risk). China has included household radio frequency beauty products in the third class of medical devices for supervision, and the market access threshold requirements have been raised. The safety, effectiveness and controllability of the whole life cycle of medical device products are the core, which means that the design and production of medical device products put forward high requirements for the professionalism, technology and understanding of relevant regulatory policies. In addition, relevant enterprises also need to have strong financial strength and management capabilities.
It is reported that the entire cycle of applying for a Class III medical device certificate needs to be at least 35 years. Relevant people from the enterprise said that on the premise of promoting the compliant and high-quality development of the industry, it is of great significance for the high-quality development of the domestic industry to give a more reasonable transition period to help enterprises achieve a smooth transition and healthy growth.