National Medical Products Administration: A large batch of high-end medical devices have achieved domestic production, with a clear price advantage

Clinically, a large number of high-end medical devices have been made domestically, gradually replacing imports, with a significant price advantage.

Jiang Deyuan, a drug and medical device inspector from the Medical Device Registration Department of the National Medical Products Administration, stated at a press conference held by the State Council Information Office on the 1st that China's medical device industry is experiencing rapid innovation and development.A large number of high-end medical devices have been domestically produced in clinical settings, gradually replacing imported products. The quality of these products is generally recognized by patients, and their prices are also more advantageous than imported products.

Jiang Deyuan stated that in recent years, the National Medical Products Administration has implemented a series of measures to promote the innovative development of the medical device industry.

In 2014, China began implementing a special approval procedure for innovative medical devices. Medical devices with Chinese invention patents, representing domestic innovations in technology, leading internationally, and possessing significant clinical application value, Enter the special approval channel and receive priority review and approval without lowering standards or reducing procedures. The registration time limit for products in this channel is 83 days less than that of similar products.

“By the end of June this year, a total of 222 products have applied to Enter this channel, and 65 products have been approved for listing. Among them, 64 are domestically produced products, accounting for 98.5%, including high-value medical consumables such as stent-type aortic endografts and interventional artificial biological heart valves,” Jiang Deyuan introduced.

Since 2016, priority approval has been given to products urgently needed in clinical settings, including medical devices involved in major national science and technology projects and key research and development plans, medical devices for diagnosing or treating rare diseases, malignant tumors, diseases specific to and prevalent among the elderly, and medical devices specifically for children. Currently, 8 products have been approved for listing, including high-value medical consumables such as drug-eluting balloon catheters and hollow fiber membrane hemodialysis filters.

In addition, last year, the drug administration agency piloted the medical device registrant system in Shanghai, Tianjin, and Guangdong, decoupling product registration from production licenses to promote innovative research and development. Currently, 13 products have been approved for listing through this method; in June of this year, the electronic application, acceptance, review, and approval process for medical devices was launched, optimizing processes and improving efficiency.

Jiang Deyuan stated that China's medical device industry continues to maintain high-speed growth, far exceeding the overall development level of the national economy, with rapid innovation and development. Clinically, a large number of high-end medical devices have been domestically produced. Transcatheter interventional valves, coronary drug-eluting stents, and orthopedic implants have basically replaced imported products, with excellent clinical effects.

“The domestic production and accessibility of high-value medical consumables is a systematic project. We are still some distance from the comprehensive domestic production of high-value medical consumables, and it requires the joint efforts of all sectors of society,” Jiang Deyuan said.