Significant price advantage in achieving localization of high-end medical devices nationwide

Jiang Deyuan, the drug inspector of the Device Registration Department of the National Medical Products Administration, said at the press conference held by the State Council Information Office on the 1st that China's medical device industry has a rapid momentum of innovation and development. In clinical practice, a large number of high-end medical devices have realized localization, gradually replacing imported products. The product quality is generally recognized by patients, and the price is also superior to imported products.

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

In 2014, China began implementing the special approval process for innovative medical devices. Medical devices with Chinese invention patents, which are domestically pioneering and internationally leading in technology, and have significant clinical application value, enter the special approval channel and are given priority review and approval without reducing standards or procedures. The time limit for registering products in this channel is 83 days less than other products in the same category.

As of the end of June this year, a total of 222 products had applied to enter this channel, and 65 products had been approved for market launch. Among them, 64 products were domestically produced, accounting for 98.5%, including high-value medical consumables such as branched aortic covered stents and interventional artificial heart valves. "Jiang Deyuan introduced.

Since 2016, priority has been given to the approval of products that are urgently needed clinically, including medical devices involved in major national science and technology projects, key research and development plans, medical devices that diagnose or treat Rare disease, malignant tumors, diseases unique to the elderly and multiple diseases, medical devices that are specifically used for children, and medical devices that are urgently needed clinically. At present, 8 products have been approved for marketing, including drug eluting Balloon catheter, hollow fiber membrane hemodiafiltration filter and other high-value medical consumables.

In addition, the Drug Administration piloted the medical device registrant system in Shanghai, Tianjin, and Guangdong last year, which unbound product registration and production licensing, promoting innovation and research and development vitality. Currently, 13 products have been approved for listing through this form; In June of this year, the implementation of electronic application, acceptance, evaluation, and approval of medical devices was initiated, optimizing the process 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. The momentum of innovation and development is rapid. In clinical practice, a large number of high-end medical devices have achieved localization, and imported products such as catheterized valves, coronary artery drug eluting stents, and orthopedic implants have been basically replaced, resulting in very good clinical results.

The localization and accessibility of high-value medical consumables are a systematic project, and we still have a long way to go before the comprehensive localization of high-value medical consumables. It requires the joint efforts of all parties in society, "said Jiang Deyuan.