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State Food and Drug Administration: a large number of medium and high-end medical equipment have bee

Clinically, a large number of middle and high-end medical devices have been localized, gradually imported and replaced, with obvious price advantage. Jiang Deyuan, the drug inspector of the device registration department of the State Drug Administration, said at a press conference held by the state new office on the 1st that the innovation and development of China's medical device industry has been rapid, a large number of high-end medical devices have been localized in clinical practice, gradually replacing imported products, the product quality is generally recognized by patients, and the price is also superior to imported products.
In recent years, the State Food and drug administration has taken a series of measures to promote the innovation and development of the medical device industry, Jiang said.
In 2014, China began to implement the special approval procedure for innovative medical devices, which has Chinese invention patents, belongs to the domestic * * technically, and has significant clinical application value in the international * *, medical devices enter the special approval channel, and will be reviewed and approved preferentially under the condition of no reduction in standards and procedures. The time limit for registering products in this channel is 83 days less than other similar products.
"As of the end of June this year, a total of 222 products have applied to enter the channel, and 65 products have been approved for marketing. Among them, there are 64 domestic products, accounting for 98.5%, including high-value medical consumables such as branch type aortic coated stent and interventional artificial biological heart valve. " Introduction to Jiang Deyuan.
Since 2016, priority has been given to the examination and approval of products in urgent clinical need, including major national science and technology projects, medical devices involved in key research and development plans, medical devices for the diagnosis or treatment of rare diseases, malignant tumors, special and multiple diseases of the elderly, medical devices for children, and medical devices in urgent clinical need. At present, 8 products have been approved for marketing, including high-value medical consumables such as drug-eluting balloon catheter, hollow fiber membrane hemodialysis filter, etc.
In addition, last year, the SFDA piloted the registration system of medical devices in Shanghai, Tianjin and Guangdong, untied product registration and production license, and promoted innovation and R & D vitality. At present, 13 products have been approved for listing in this form. In June this year, the whole process of application, management, review and approval of medical devices was launched electronically, so as to optimize the process and improve efficiency.
Jiang Deyuan said that China's medical device industry continues to maintain rapid growth, far higher than the overall development level of the national economy, with rapid innovation and development momentum. In clinic, a large number of high-end medical devices have been localized. The valves, coronary drug-eluting stents, orthopedic implants and other basic substitutes for imported products through catheter intervention have a very good clinical effect.
"The localization and accessibility of high-value medical consumables is a systematic project. We are still far from the full localization of high-value medical consumables, which requires the joint efforts of all parties in the society." Jiang Deyuan said.


 
 
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