In recent years, China's medical device industry has developed rapidly, with the in-depth application of artificial intelligence, 3D printing, material science, genetic diagnosis and other high-tech, the field of medical devices is active in innovation, multidisciplinary intersection, high-tech intensive, professional talent gathering characteristics have further emerged. Compared with the depth and breadth of medical device professional knowledge, the number of medical device inspectors in China is insufficient, and the contradiction between professional supervision capabilities and the current situation of the industry is increasingly prominent.
To have the ability to confirm compliance and risk judgment, medical device inspectors need deep professional knowledge reserves, long-term inspection experience, rich on-site inspection professional skills as support, and constantly update professional knowledge and optimize the knowledge structure with the development of the industry. This paper intends to explore the professional development mechanism of medical device inspectors in China and provide reference for the establishment of a professional medical device inspector team in China.
Build tiered teams
According to the spirit of the Opinions of the General Office of the State Council on Establishing a Team of Professional and Specialized Drug Inspectors (hereinafter referred to as the "Opinions"), professional professional inspectors at the national and provincial levels should clearly divide the inspection powers, and inspectors can cultivate professional directions and abilities according to different powers.
Inspectors at the national level should include overseas inspectors and national inspectors, focusing on the technical supervision and causal inspection of medical devices with high safety risks, high public opinion risks, strong innovation and high technical complexity, and need to have relevant professional knowledge background, be able to continuously expand in terms of professional depth, have in-depth research on the biosafety, process and testing of medical devices, have higher requirements for risk research and judgment capabilities, and should have technical authority. On this basis, overseas inspectors should be familiar with the requirements of relevant regulations and standards of international mainstream national medical devices, have good language skills and the ability to find problems, and be able to undertake the inspection of imported high-risk products.
Provincial inspectors are mainly engaged in the daily supervision of the production, operation and use of medical devices, focusing on judging the compliance, authenticity and compliance of the dynamic operation of the enterprise's production quality management system, and have high requirements for the application ability of regulations, professional breadth, investigation and evidence collection.
Therefore, when setting up the selection and evaluation standards for inspectors, full consideration should be given to the division of inspection powers and the opportunities for inspector evaluation and selection, so as to not only meet the work needs of the two levels of inspectors to the greatest extent, but also continuously select excellent inspectors from the provincial level to enrich the national inspector team.
Establish medium- and long-term development plans
At present, the existing inspector team in China has the phenomenon of insufficient personnel, grade fault, and unstable team, in view of these situations, it is recommended to estimate the inspection workload of production, circulation and use links in detail according to the scale and current situation of China's medical device industry, and formulate a medium- and long-term development plan for the construction of the inspector team.
The medium-term plan should mainly meet the quantitative requirements, and it is recommended that in the next 5 years, the number of full-time inspectors at the national level will reach 200, and the provincial inspectors will be equipped with inspectors according to the actual situation and risk level of the medical device industry in each province (autonomous region and city), according to the ratio of 3:1 for three types of high-risk medical devices, 10:1 for second-class medium-risk medical devices, and 20:1 for first-class low-risk enterprises, so that the team of inspectors can take shape and basically meet the needs of various inspection tasks.
It is recommended that in the next 10 years, establish and improve the mechanism for recruitment, training, selection, hierarchical and categorical management, promotion and withdrawal of inspectors, determine the level and salary scale of inspectors, focus on improving the capacity building of inspectors, further improve the quality of inspectors, and enrich the inspection force.
Establish and improve training mechanisms
Considering the similarity between China and the United States in terms of medical device regulatory models, it is recommended to learn from the training and hiring procedures of FDA inspectors in the United States to set inspector standards and training courses.
General literacy and basic literacy are the foundation of professional capacity building of inspectors. The recommended training content includes national integrity and confidentiality regulations, inspectors' professional ethics, interpersonal communication skills, psychology, occupational safety and safe handling of emergencies, evidence science and on-site evidence, production quality management system related standards (ISO13485, ISO9001 and other series), risk management, clinical evaluation, process confirmation, statistical technology, medical device related regulations and other general courses.
In the setting of teaching methods, a flexible credit accumulation system combining online learning and classroom centralized teaching and interaction can be adopted.
Establish a training and evaluation mechanism in professional fields
In order to ensure the consistency of the training and evaluation of inspectors in various provinces (autonomous regions and municipalities), it is recommended that the State Food and Drug Administration formulate the basic requirements for the training and evaluation of national and provincial inspectors, and that the provincial drug regulatory authorities improve and implement the training, evaluation and professional authorization of provincial inspectors according to the current situation of the industry and the needs of inspectors in each province (autonomous region or municipality), and the State Food and Drug Administration improves and implements the training, evaluation and professional authorization of national inspectors.
Targeted training for different professions
It is recommended to systematically train inspectors of different professional categories in combination with the current effective national standards, industry standards, technical review guidelines, verification guidelines and other technical requirements, and interpret the connotation of standards and guidelines.
It is recommended to lead on-site inspections according to professional categories
It is recommended that on-site inspections be carried out according to professional categories, and that inspectors should cover all the contents of the Good Manufacturing Practice for Medical Devices and its corresponding appendixes, provincial inspectors should have at least 5 full verification experience, and national inspectors should have at least 10 full verification experience.
Assess professional abilities based on comprehensive background
It is recommended to evaluate the professional competence of inspectors based on their professional background, inspection experience, technical titles, and work performance, and keep evaluation records. Professional authorization is granted by major categories (active, passive, IVD), and inspectors with cross disciplinary inspection capabilities are allowed to authorize up to two professional fields.
Ensure the continuity of inspector's work ability
After obtaining the qualification of an inspector, it should be maintained and 5 on-site inspections should be completed within 12 months, including at least 1 full inspection.
Maintaining continuous professional development can be achieved through continuing education and knowledge updating courses. For example, within 12 months, inspectors can complete at least 20 hours of continuing education through independent online courses, centralized classroom training, academic exchange meetings, standard formulation and revision, industry forums, on-site observation and practice, etc., to keep their knowledge updated and keep up with the times.
Establish a registration management system for inspectors
For personnel who have passed the assessment and evaluation and have been included in the inspector database, one person per file will be implemented, and online platform registration management will be carried out. The inspector's resume, training experience, assessment and evaluation results, and annual inspection performance will be recorded and updated in real-time, and the inspector's status will be kept up-to-date. Inspectors who have not been engaged in inspection work for a long time will be marked and reminded. The National Drug Administration system can interface with the provincial-level drug administration system, and the National Drug Administration can review the qualifications of inspectors in the provincial-level system database and carry out the selection of inspectors from the National Drug Administration.
Establish a promotion and exit mechanism for inspectors
Inspector promotion is a good way to expand the career development space of inspectors and an important part of the incentive mechanism for inspectors. It not only reflects the professional level of inspectors, but also recognizes their ability to perform their duties.
The Opinion requires that the salary and benefits of inspectors be linked to their technical titles, the difficulty of inspection work, and the amount of inspection tasks, and a salary incentive mechanism tilted towards the front line of on-site inspection should be established. On the basis of researching the salary levels of the medical device industry, it is recommended to set different salary levels and incentive mechanisms for inspectors at the four levels of junior, intermediate, senior, and expert levels, referring to the existing judge and registrar sequences in China, to ensure the risk and salary matching of professional inspectors. On the one hand, it reflects the professional value and sense of honor of inspectors and stimulates their enthusiasm; On the other hand, it also reduces the risk of integrity and reduces personnel turnover.
At the same time, it is recommended to gradually improve the exit mechanism for medical device inspectors and form a dynamic and effective mechanism for the appointment of inspectors to ensure the professionalism and professionalism of the inspector team.
Medical device inspectors are the main regulatory force promoting the healthy development of China's medical device industry. Inspectors conduct compliance checks and risk assessments on medical device products, which can reduce post market risks and further ensure safety and effectiveness. It is recommended to attach importance to the establishment of a professional development mechanism for inspectors in the process of building a professional and specialized inspector team.
(This article is excerpted from the "Preliminary Study on the Professional Development Mechanism of Medical Device Inspectors in China", Issue 21, 2019, in the Chinese Medical Device Information.)