NMPA: Encouraging the launches of innovative medical devices

On July 5th, the State Council Information Office held a series of press conferences covering the review and approval of medical devices, medical device regulation, innovative medical devices and other industry issues of concern.

217 medical devices approved innovations

In recent years, a total of 130 innovative drugs and 217 innovative medical devices have been approved, and only in the first half of this year, 24 innovative drugs and 28 innovative medical devices were approved and launched.

Jiao Hong, the Director of National Medical Products Administration (NMPA), pointed out that it is necessary to promote innovation-driven, high-quality development of the pharmaceutical industry with service supports. 

Encouraging innovation is key to the reform of the review and approval system for drugs and medical devices. Over the years, we have accelerated the formulation and revision of supporting rules and regulations for the registration and management of drugs and medical devices, continuously releasing policy supports.

Optimizing the approval process of innovative high-end medical devices

China's medical device industry is in a stage of rapid development, with a compound annual growth rate of 10.54% over the past five years. China has become the second largest market for medical devices in the world, and the degree of industrial agglomeration and international competitiveness is constantly improving.

Together with other departments, NMPA jointly issued the "14th Five-Year Plan for National Drug Safety and Promotion of High-Quality Development", "14th Five-Year Plan for the Development of the Medical Equipment Industry" and other documents to form policy supports.

Meanwhile, taking innovative medical devices as the focus, NMPA issued "Innovative Medical Devices Special Review Procedures" and "Medical Device Priority Approval Procedures" to set separate queue and accelerated process for innovative products and urgent clinical needs.

A part of new medical devices included in sampling

Since the national collection, NMPA annually carried out the special regulation towards the collected drugs and medical devices, to supervise and inspect their manufacturers in products sampling, adverse drug reactions/ medical device adverse events monitoring.

The inspection involved nearly 600 drug manufacturers and 170 medical device manufacturers; the product sampling involves 333 drug varieties and 15 medical device varieties, which has strongly guaranteed the quality and safety of collected drugs and medical devices.

NMPA will continue to increase the supervision of collected products. In terms of medical devices, it will implement list management for collected products such as vascular stents, artificial joints and orthopedic spinal products, and include them into sampling.