On December 4th, the State Food and Drug Administration issued a message and will publicly seek advice from the industry on the " Medical Device Classification Rules (Draft for Comment)".
The reporter learned from the draft for comment that the new regulations will be divided into three categories according to the degree of risk of medical devices, according to the degree of risk from low to high, and the management categories of medical devices are divided into the first category (Class I) and the second category ( Class II) and Class III (Class III).
Earlier, the source said in an interview with the Economic Information Daily that if the new regulations are successfully implemented, the Food and Drug Administration will also issue regulations, regulatory documents, and other relevant departments for registration, production, operation, and use. All aspects of the equipment, in order to promote the structural adjustment and industrial upgrading of the medical device industry , enhance the quality and safety of China's medical equipment.
In Zhao Zhen, an analyst of Zhuo Chuang Information Pharmaceutical Industry, the “category supervision†idea in the draft for comment will have a certain impact on the future supervision of the medical device industry.
As far as domestic industries are concerned, the implementation of classified supervision, industry norms will be clearer, and standards will be more standardized, which will help improve the overall concentration of the medical device industry. "These effects will definitely appear gradually, because there are more medical device companies in China than drug manufacturers. It is estimated that there are about 15,000 companies of various sizes and sizes, and thousands of products." He told the reporter of "Daily Economic News" that "the average output value of each enterprise in China is now less than 10 million yuan. If the draft for comments can be reached, the average output value of related enterprises will rise accordingly."
Zhao Zhen expects that after the new regulations are put into place, the leading position of the medical industry in Jiangsu, Zhejiang, Shanghai and Beijing and Tianjin will be further strengthened, and good medical equipment resources will flow more to these areas.
In terms of the specifications of medical devices, the future regulatory authorities should have follow-up actions, including optimization, registration and supervision.
In the future, China's grassroots institutions have a greater demand for medical devices, and the market potential in this regard is relatively large. Coupled with the regulatory spirit of the Exposure Draft, it will be easier to promote the sinking of medical devices in China in the future, which is good for developing practical and popular products, and home-based medical devices will have more room for development.
As for the impact on the imported equipment market, Zhao Zhen believes that if the draft for comment can be successfully carried out, especially after the classification of the regulatory categories is clear, the future import of equipment will increase the index limit for many products, and develop the healthy circulation of the domestic medical device market. Provide an opportunity.
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