Sun Lei, Director of the Device Review Center: Promote the reform of the medical device review and approval system in depth

In recent years, the reform of the medical device review and approval system has been further advanced, requiring the establishment of a more scientific and efficient medical device review and approval system

Recently, a reporter from China Medical News interviewed Sun Lei, director of the Device Review Center, on how to continue to deepen the reform of the medical device review and approval system

Reporter : Hello Director Sun! The new crown pneumonia epidemic is the most serious infectious disease pandemic in the world in a century

Sun Lei: Doing a good job in the emergency review of products related to the prevention and control of the new crown pneumonia epidemic has been the top priority of our work in the past two years

In order to ensure product quality and safety, the Device Review Center quickly formulated and released three review points including the "Key Points for Technical Review of Registration of 2019 Novel Coronavirus Nucleic Acid Detection Reagents" to provide guidelines for technical review and enterprise product development

During the epidemic, the Device Review Center made full use of the electronic registration system (eRPS) for medical device registration to realize remote submission of electronic application materials by enterprises, and real-time remote online review by reviewers, effectively promoting the smooth development of review work under the epidemic situation

By the end of 2021, the Device Review Center has completed 68 new coronavirus detection kits, 12 supporting instruments and equipment, 5 blood purification equipment and their supporting consumables, 6 extracorporeal cardiopulmonary support auxiliary equipment and their supporting consumables, 10 ventilators, Emergency review of 4 software and 3 dressing products

This emergency review is a major test of the effectiveness of the reform of the medical device review and approval system, and the Device Review Center handed in a satisfactory answer sheet

Reporter : Since the start of the reform of the medical device review and approval system, the Center for Device Review has vigorously promoted review and scientific research.

Sun Lei: Review science is a key element in the reform of the medical device review and approval system

On the one hand, the Center for Device Review continuously promotes the unification and implementation of the scientific concept of review

On the other hand, the Center for Device Review has continuously improved the construction of the review system

In addition, the Center for Device Review has also implemented the requirements of the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices" issued by the General Office of the CPC Central Committee and the General Office of the State Council in 2017.

The reform is still in progress, and the evaluation and scientific research needs to be further deepened

Reporter : In the past two years, China's innovative medical devices have been accelerated to market

Sun Lei: In order to encourage the innovation of medical devices and encourage the high-quality development of the industry, the State Food and Drug Administration revised and issued the "Special Review Procedures for Innovative Medical Devices" in 2018; Incorporate medical device innovation into the development focus, and propose to give priority review and approval to innovative medical devices

In order to speed up the launch of innovative products, the Device Review Center has taken a series of measures
.
The first is to revise and publish the "Special Review Application Review Operational Specifications for Innovative Medical Devices" and "Innovative Priority Medical Device Registration Technical Review Communication Operational Specifications" to improve the review workflow and open a green channel for innovative medical devices
.
For products entering the special review process for innovation, adopt early intervention, full guidance, face-to-face communication, etc.
, to solve the applicant's problems in key technical nodes such as product research and development, application, review, etc.
, and the standards and procedures are not reduced.
Priority review and approval will be given under the following conditions, so that innovative products "queue alone and run fast"
.
At present, more than 383 products have entered the green channel of innovative medical devices, and 155 products with strong innovation, high technology content and significant clinical value have been launched
.
In 2021 alone, 35 innovative medical devices will be approved for the market, making it the year with the largest number of approvals for innovative products in recent years
.

The second is to strengthen the liaison and cooperation with the provincial drug regulatory authorities, establish innovative service stations in some provinces (autonomous regions and municipalities), give full play to their respective advantages in technical review and regulatory practice, and strengthen the guidance on local innovative medical device declarations
.

Innovation is risky, but not innovating brings greater risk
.
This requires us to firmly control risks while innovating to achieve high-quality and efficient innovation
.
Based on the "Basic Principles of Medical Device Safety and Performance", the Center for Device Review has formed the "Working Principles for the Revision of Medical Device Product Catalogue Exempted from Clinical Evaluation"; formulates scientific planning and operational specifications for the formulation and revision of guiding principles and technical review points, Organize relevant work and improve the coverage of medical device products
.
At the same time, it actively participates in international medical device working groups such as IMDRF (International Medical Device Regulators Forum) and GHWP (Global Council for Harmonization of Medical Device Regulations), and undertakes scientific research projects such as the National Key R&D Program and the China Drug Regulatory Science Action Plan
.
By formulating and transforming new tools, new standards and new methods for evaluating the safety and effectiveness of medical devices, we will accelerate the process of medical device industry innovation and product launch
.

Reporter : Talent is the driving force for the development of a career
.
In recent years, the team of reviewers of the Center for Device Review has grown continuously, enriching the technical review force
.
With the gradual refinement of review requirements, the composition of reviewers tends to be diversified, and the technical review capability and level need to be continuously improved.
What kind of reviewer training model has the Center for Device Review adopted? What kind of reviewer management system has been established?

Sun Lei: In May 2021, the General Office of the State Council issued the "Implementation Opinions on Comprehensively Strengthening the Construction of Drug Regulatory Capacity" (hereinafter referred to as the "Implementation Opinions"), which clearly proposed "improving technical review capabilities" and "improving the quality of supervision teams"18 key work
.

Starting from the actual needs of review work and talent growth, the Center for Device Review has established a professional and systematic reviewer education and training system that meets the characteristics of multi-disciplinary, cross-disciplinary, and high-tech-intensive medical device technical review, formulates annual training plans, and prepares Personalized education and training schedules, through theoretical study, technical seminars, observation and training, etc.
, strengthen reviewers' grasp of business knowledge, regulatory regulations, product production research and development, and cutting-edge technology, and consolidate and improve review capabilities
.
In addition, a classification and classification management and evaluation system for review qualifications has been established according to the professional fields of products and the difficulty of review, further promoting the rational allocation of review resources, and improving the quality and scientific level of review
.

This year, the device review center will carry out multiple sessions of special business training in a combination of online and offline methods, with training as an important starting point, to further strengthen the capacity building of the system-wide review team
.

Reporter : We all know that the technical review of medical devices is a complicated process
.
How does the Device Review Center establish communication channels for registration applicants and provide business guidance and services? What measures have you taken in smart review and informatization construction, and what are the results?

Sun Lei: Technical review and communication are two aspects of the same thing, which are inseparable.
Good and sufficient communication is the lubricant for registration application and technical review
.

In recent years, the Center for Device Review has continued to deepen the implementation of the reform spirit of "delegating power, delegating power, regulating services", actively building a communication service platform for registration applicants, continuously optimizing various communication channels, and improving the efficiency of medical device registration technical review services
.
At present, 12 external consultation and communication systems have been standardized and formed, covering external consultation services through conventional channels before the acceptance of medical device registration applications, during the acceptance process, and during the review process, as well as innovative product registration, priority approval product review, and clinical trials.
The whole process of external consulting services for special channel products such as approval
.
In 2021, we also innovatively built the "Device Review Cloud Classroom" online training platform, which provides courses such as review process introduction, rules and regulations interpretation, review requirements explanation for R&D registrants, regulators, and scientific researchers, etc.
, to meet the needs of the medical device industry.
The individual needs of all parties
.

Smart review and informatization construction have also been the focus of our work
.
At present, the device review center has completed the transformation of the technical review consulting platform, incorporating all communication channels into the management of the consulting platform, and integrating with the eRPS system to realize one-stop login for registration applicants using digital certification certificates (CA), creating functions A more complete "applicant's window" will further improve work efficiency with the help of big data and artificial intelligence, and strive to use information technology to promote the quality and efficiency of review
.

Reporter : In December 2020, the Yangtze River Delta Branch Center and the Greater Bay Branch Center of Medical Device Technology Review and Inspection were listed
.
What is the strategic significance and work focus of the two sub-centers? What is the current construction situation?

Sun Lei: The establishment of the two sub-centers is an important measure to serve and support the high-quality development of the pharmaceutical industry.
It is not only conducive to the efficient promotion of local review and inspection work, better support for the innovation of pharmaceutical R&D enterprises, but also good corporate-oriented regulations.
Policy advocacy training and more targeted regulatory scientific research
.

We will build the two sub-centers into a practice platform for promoting the high-quality integrated development of the Yangtze River Delta region and the Guangdong-Hong Kong-Macao Greater Bay Area, a cooperation platform for deepening the reform of the medical device review and approval system, and an incubation platform for serving the innovation and development of the pharmaceutical industry.
Promote the Yangtze River Delta region and the Guangdong-Hong Kong-Macao Greater Bay Area to become the most dynamic medical device innovation highlands to better meet the people's new expectations for medical device safety and innovative research and development
.

At present, the two sub-centers have begun to undertake some medical device technical review services, including review tasks assigned by the review business system, consultation on technical issues before acceptance, green channel medical device communication, on-site review participation, and medical device registration.
Special training on technical review, etc.
, and corresponding standard operating procedures have been established
.
At the same time, for the medical devices that have been included in the innovation and priority review channels and are likely to achieve breakthroughs in key technologies and core components, complete domestic substitution, and solve the problem of "stuck neck", a working mechanism of special personnel responsible, active docking, and full guidance has been established.
, the focus of exploration and review is gradually moved forward to the product development stage, and comprehensively promotes industrial innovation
.

Reporter : At present, the medical device industry is booming, which puts forward higher requirements for technical review
.
What are the work plans of the Center for Device Review in 2022?

Sun Lei: In 2022, the Center for Device Review will further implement the "Implementation Opinions", in accordance with the requirements of the "National "14th Five-Year Plan" Drug Safety and Promotion of High-quality Development Plan", centering on the construction of "double first-class" review institutions and review teams , continue to deepen reform, strengthen the construction of review capacity; continue to encourage innovation, establish innovative review strategies; give play to the role of review and scoring centers and external scientific research forces in key regions of the medical device industry, build a modern review system; strengthen personnel training, develop systematic Personalized training, building a professional and professional review team, and promoting the reform of the medical device review and approval system in depth
.