In recent years, China’s medical device industry has been developing rapidly, with a compound annual growth rate of 10.54 per cent over the past five years, and has become the second largest market for medical devices in the world. In this process, innovative devices, high-end devices continue to be approved, device access, regulatory system is also improving.
Today (5 July), the State Council Information Office held “authority to talk about the opening” series of thematic press conference, the State Drug Administration, Jiao Hong, Director of the State Drug Administration to introduce the “strengthening of drug supervision and effective protection of the people’s safety of medicines” related to the situation.
The meeting talked about medical device review and approval, medical device regulation, innovative medical devices, medical devices online sales and other industry concerns.
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217 Innovative Medical Devices Approved
Medical device innovation results into the explosive period
State Drug Administration Secretary Jiao Hong pointed out at the meeting that adhere to the innovation drive, services to support the high-quality development of the pharmaceutical industry. The drug and medical device review and approval system has been promoted in an orderly manner, the review and approval process has been continuously optimised, and a large number of innovative drugs and innovative medical devices have been approved and listed. 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 for listing.
Jiao Hong said that the State Drug Administration continues to deepen the reform of the review and approval system of drugs and medical devices, and the policy dividends related to encouraging innovation are also being released. Through the acceptance and approval of drugs and medical device products in these years, including the acceptance and review in the first half of this year, it can be clearly seen that China’s drug and medical device innovation has entered an explosive period.
Encouraging innovation is the core essence of the reform of the drug and medical device review and approval system. Over the years, we have accelerated and strengthened the formulation and revision of supporting rules and regulations for the registration and management of drugs and medical devices, and continuously released policy dividends. Through the tilting of relevant resources, we have further increased the listing of new drugs with clear clinical value, drugs for urgent clinical needs and medical devices.
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Optimising the Approval of Domestic Substitution, “Necklace”, Innovative and High-end Device Products
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, according to official data. At present, China has become the world’s second largest market for medical devices, industrial agglomeration, international competitiveness continues to improve.
Xu Jinghe, deputy director of the State Drug Administration (SDA), talked about that in recent years, the SDA has strengthened top-level design and promoted departmental synergy. The State Drug Administration and a number of departments jointly issued the “14th Five-Year Plan” for national drug safety and promotion of high-quality development, to clarify the overall principles, goals and tasks of promoting high-quality development of the medical device industry. Jointly issued the “14th Five-Year Plan for the Development of Medical Equipment Industry” with the Ministry of Industry and Information Technology, the National Health Commission and other departments to form policy synergy.
We took the lead in establishing two technological innovation cooperation platforms for artificial intelligence medical devices and medical biomaterials, accelerated the transformation and application of related scientific and technological achievements in the field of medical devices, cooperated with the work of unveiling and launching related products, and focused on the frontiers of scientific and technological development, and laid out the plan in advance.
Strengthening regulatory scientific research and constantly innovating review initiatives. Launch the implementation of China’s drug regulatory science action plan, focusing on technology and regulatory frontiers to continuously research and develop new tools, standards and methods for medical device regulation. Establish a working mechanism for technical review to move forward to the product development stage, focusing on high-end medical devices such as ECMO, particle therapy system, ventricular assist system, etc., intervene and guide in advance, accelerate the key core technology research and development, and take the lead to boost the breakthrough of high-end medical devices in China.
Encourage the listing of innovative medical devices to promote the high-quality development of the industry. In recent years, the State Drug Administration to innovative medical devices as the main point of attack, has issued “innovative medical devices special review procedures”, “medical device priority approval procedures”, so that innovative products and clinically urgent products “separate queue, all the way to run”.
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These medical devices, into the national sampling
Xu Jinghe said, the State Drug Administration attaches great importance to the collection of drugs, medical devices regulatory work, in strict accordance with the principles of risk management, the whole process of control, scientific supervision, social co-governance, the full implementation of the “four most stringent” requirements, the full implementation of the main responsibility of enterprise quality and safety and drug regulatory departments local responsibility, and strive to serve the national collection of work and the overall situation of health care reform work. and the overall situation of medical reform.
Since the implementation of the national collection work, the State Drug Administration has deployed annually to carry out the special supervision of the selected drugs and medical devices in the collection work to achieve the supervision and inspection of the manufacturers of the selected drugs and medical devices in the national collection, the sampling inspection of the products in the production, and the monitoring of the adverse drug reactions (adverse events of the medical devices), which has also been approved by the State Medical Insurance Bureau. This work has also been strongly affirmed by the State Medical Insurance Bureau.
The inspection involves nearly 600 drug manufacturers and 170 medical device manufacturers; the product sampling involves 333 drug varieties and 15 medical device varieties, which strongly guarantees the quality and safety of collected drugs and medical devices.
At the same time, comprehensively strengthen the implementation of the main responsibility of enterprises and the implementation of local regulatory responsibility, from the supervision and inspection, supervision and sampling, adverse reactions (adverse events) monitoring and other work, the national collection of selected drugs and medical devices quality and safety situation is good.
In the next step, the State Drug Administration will continue to increase the supervision of products selected in the national collection and procurement, strengthen risk prevention and control, comprehensive use of supervision and inspection, sampling, adverse reaction (adverse event) monitoring and other means to strengthen the risk of hidden danger early warning, early detection and early disposal. In terms of medical devices, list management has been implemented for products selected from the national collection of vascular stents, artificial joints and orthopaedic spinal products, and medical devices selected from the national collection have been included in the national sampling inspection.
Continuously improve the capacity of drug supervision, innovate supervision methods and approaches, strengthen intelligent supervision, strengthen the data analysis and sharing application of regulatory information on collectively selected drugs and medical devices, and continuously improve the effectiveness of supervision through information technology, so as to ensure the quality and safety of the products.
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Post time: Jul-19-2023