Source: China Medical News

A number of academicians, experts and enterprise representatives, regulators are based on China's medical equipment industry and regulatory practice, focus on innovation and safety, plotting the medical device regulatory science system in our country, around the theme of regulatory science and innovation and development, cutting-edge trends, product research and development of science and technology innovation, the review for examination and approval system reform, scientific problems in aspects of post-marketing surveillance carried on the thorough discussion. Director Jiao Hong of SFDA attended the meeting and made a speech. Vice Director Xu Jinghe presided over the meeting.

At the meeting, Jiao Hong pointed out that, "The strategic research on the scientific implementation plan of China's medical device regulation is a key step to promote the sustainable development of China's medical device regulation and industry. It is an important work to lay the foundation and make long-term benefits."

Regulation, the cornerstone of innovation, is the way to go

 In recent years, cutting-edge technologies such as artificial intelligence, 3D printing and nanotechnology have constantly refreshed people's traditional perception of medical device products.

  Market changes often precede regulation. However, as a necessary means to regulate industrial innovation and development, regulation should not follow one's footsteps, but should be stored as soon as possible to fill the gaps of knowledge and ability.

  "It is a major responsibility to ensure the safety of medical devices, which requires timely planning and regulatory scientific research." Jiao Hong pointed out that regulatory science is a link between cutting-edge technology and the development of safer and more effective new medical devices, and a bridge between scientific regulation of medical devices and industrial innovation and development.

The development of regulatory science is the internal requirement of industrial innovation. Jiao Hong stressed that in the face of the surging scientific and technological innovation and the accelerating pace of medical device product innovation, we must closely follow and understand the current trend of scientific and technological development in the world, constantly improve the ability to grasp new technologies and new products, and constantly develop new regulatory tools and methods; It is necessary to think deeply about how government regulation can ensure the adoption of efficient regulatory models and methods for the evaluation and approval of new medical devices, which can not only promote the development and marketing of high-quality products, but also effectively eliminate products that cannot be proved safe and effective. How to optimize the technical evaluation requirements of new medical devices should be studied in detail, and the scientific research and data requirements should be clarified. Must accelerate through the scientific management to support product quality improvement, in the supervision work to introduce more scientific and more novel methods, continuously improve's ability to grasp new technology, new products, with scientific attitude, professional spirit, strengthen the risk prevention and control in whole life cycle of medical apparatus and instruments, improve the quality and safety of medical equipment.

Broaden regulatory vision and absorb international experience

With the deepening of globalization, the medical device industry has been highly internationalized. It has become the need of The Times to learn from the regulatory experience of developed countries and improve the regulatory level of medical devices in China.

In recent years, China's voice in the field of international medical device regulation has been constantly enhanced. In 2013, China formally joined the International Forum of Medical Device Regulators (IMDRF) with the approval of the State Council. Over the past five years, China has continuously strengthened exchanges with the United States, the European Union, Canada and other IMDRF member states, promoted the coordination and integration of regulations, actively learned from international advanced experience, and worked hard to broaden the international horizon of regulation and improve the level of regulation.

 In March this year, China successfully hosted the 13th IMDRF Management Committee meeting in Shanghai for the first time as the ROTATING presidency of the IMDRF. Two new work projects proposed by China, "Clinical Evaluation of Medical Devices" and "List of International Standards for IMDRF Member Accreditation", have been approved by all member countries and approved by the IMDRF Management Committee. These projects represent the hot spots and development trends of international regulatory scientific research. At the IMDRF management Committee meeting to be held in Beijing in September, China's drug regulatory authorities will also apply for new projects based on the regulatory requirements for the development of medical devices.

The development of regulatory science is an inevitable trend of regulatory internationalization. Jiao Hong stressed that although countries have different laws, systems and mechanisms for medical devices and different regulatory forms, there are common rules to follow in administrative supervision.

Jiao Hong says, supervisory science is ceaseless exploration and development. At present, the use of real world data, the optimization of clinical trial design and the innovation of regulatory evaluation methods concerned and studied by various countries are common problems in the regulatory work of medical devices. Research on regulatory science is an important exploration to stand in the forefront of international regulation, absorb regulatory experience from other countries, and strive to be in line with international advanced regulatory level. It is also a fundamental and strategic work to further understand China's regulatory reality, explore the rules of regulation, and strive to solve the problems faced by China's medical device regulation. To systematically study the historical evolution and development of international regulatory science and fully draw on the latest research results of international regulatory science will play a positive role in promoting the development of medical device regulatory science in China.

A path of scientific planning with Chinese characteristics

Jiao Hong said that in recent years, the supervision of medical devices has made obvious progress. Since June 1, 2014, the newly revised Regulations on The Supervision and Administration of Medical Devices have been implemented, marking that China's medical device supervision has entered a new stage. State food and drug administration system and mechanism innovation, deepen the review and approval system reform, continue to encourage product innovation, and strive to strengthen the post-marketing surveillance, pay attention to the risk prevention and control, strengthening the management of technical evaluation, standard, testing, inspection inspection, adverse event monitoring and other technical support organization construction, efforts to improve the supervisory ability and level, truly scientific supervision and regulation of wisdom.

In recent years, the medical device industry has been developing rapidly, and the number of product registration applications has been increasing year by year: less than 1,000 in 1997, 1,500 in 2000, 6,737 in 2008, and 11,233 in 2014, a record high. Over the past decade, the number of medical device registration applications has increased by more than 10 times.

The press learned from the meeting that since 2014, a total of 41 innovative medical devices, including implantable pacemakers, percutaneous artificial heart valve system, vascular reconstruction device, abdominal aorta covered stent system, have been approved to market through the special approval procedure. Since the implementation of the priority approval procedure in January 2017, five products, including drug-eluting balloon catheter and hollow fiber membrane hemodialysis filter, have passed the priority review and been approved for marketing. The review time of innovation and priority products is greatly shortened compared with the normal review time, which effectively promotes the product registration and listing process, makes more advanced medical devices put into use, benefits the people, and further stimulates the innovation vitality of the industry, which is well received by all sectors of society.

Jiao Hong pointed out that China's medical device industry is developing rapidly, the construction of pilot free trade zones is advancing rapidly, regional cooperation is being strengthened, the medical device listing license holder system is being promoted, and industrial restructuring and new forms of business are constantly emerging. All these require regulatory authorities to keep abreast of industrial development and demand, innovate regulatory methods, adapt to changes such as industrial restructuring and relocation, and improve regulatory policies. At the same time, it should also be noted that the safety of medical devices is still in a period of high risk due to the impact of factors such as industrial foundation, market perfection, and comprehensive social governance level. Violations of laws and regulations are complex, diverse, and hidden, and many other problems unique to China. How to solve China's regulatory problems and develop systems and measures suitable to China's national conditions based on an original scientific regulatory system with Chinese characteristics as the foundation and support. We should seek truth from facts and keep pace with The Times to meet the new challenges in the safety, effectiveness, quality and accessibility of medical devices in the new era.

For medical device regulatory science development path, JiaoHong thinks, can from the following six aspects: one is to optimize the design of the supervision system, to carry out the public review before the examination and approval, post-marketing surveillance system and the mechanism of strategic research, adhere to the concept of risk management, in the thorough analysis, scientific research, accurately grasp the risk point, on the basis of scientific develop complete regulation; Second, optimize clinical evaluation, use real world data to evaluate clinical risks of products, scientifically and rationally set clinical trial requirements, and improve clinical trial design methods and tools, including optimizing statistical methods; Third, formulate reasonable classification principles of medical devices, improve the dynamic adjustment mechanism of medical device classification management, and carry out scientific supervision on the basis of leniency and severity; Fourth, formulate a scientific regulatory system, clarify the regulatory model, research and development technical standards and guiding principles for personalized and customized medical devices and organizational engineering medical products; Fifth, it aims at forward-looking technologies, such as regulatory policy research in the fields of artificial intelligence, big data, network security, gene diagnosis and precision diagnosis. Sixth, we will promote the informatization project of supervision, integrate big data of supervision, and conduct scientific research on intelligent supervision.