Exploration of the Regulatory Approach to Medical Devices under the New Situation

With the rapid advancement of technology, the medical device field has seen a continuous stream of innovations. Innovative medical devices and new business models are reshaping the medical device industry and presenting new challenges for medical device regulation.

To effectively regulate medical devices in this new environment, we must first clearly understand the current challenges facing regulatory work and adopt targeted measures to develop effective regulatory strategies, continuously resolving regulatory problems in practice.

Medical Device Regulation Faces New Challenges

Regulatory Workforce Development Needs Strengthening 

Currently, China's medical device regulatory work faces challenges such as insufficient regulatory personnel and the need to improve the professional level of the regulatory workforce.

Insufficient Number of Regulatory Personnel.Taking Tianjin as an example, the city currently has 449 medical device manufacturing enterprises, 5536 operating enterprises, 514 online sales enterprises, and over 6000 user units. The city has a total of 85 medical device regulatory personnel, including 23 responsible for production regulation and 62 for circulation regulation. The number of regulatory personnel is in the middle and upper reaches nationally.

In recent years, regulatory departments across the country have continuously strengthened regulatory workforce development, but in the current and foreseeable future, insufficient regulatory personnel will remain one of the regular challenges faced by medical device regulatory work.

The Professional Level of the Regulatory Workforce Needs Improvement.Medical devices encompass a wide range of product categories and professional fields. Becoming a qualified medical device regulator requires systematic learning of regulations and professional knowledge, necessary inspection skills training, and the accumulation of long-term practical experience.

Meanwhile, due to personnel adjustments and rotations in various government departments, many experienced medical device regulators, especially those at the grassroots level, have experienced significant attrition. Currently, the overall business capabilities of medical device regulatory personnel cannot fully meet the needs of regulatory work, and workforce capacity building urgently needs strengthening.

Relatively Backward Regulatory Concepts

Due to factors such as the nature of work and working environment, the innovative vitality of regulatory personnel is insufficient, the speed at which regulatory departments accept new things needs to be improved, and work approaches still need to be explored.

For example, many regulators are still accustomed to "nanny-style" regulation, controlling every move of the enterprise. This regulatory approach greatly restricts the development of enterprises and increases the workload of regulatory departments. Under the influence of this concept, some enterprises are accustomed to working according to "instructions," which is objectively detrimental to stimulating their innovative vitality and enhancing their sense of primary responsibility.

Regulatory Methods Urgently Need Innovation

Today, the medical device field is experiencing rapid technological development, with new products emerging continuously. Meanwhile, the regulatory situation differs from the past, and traditional regulatory concepts and methods can no longer meet the needs of improving regulatory efficiency. New business models such as online sales, vending machines, and financing leases pose new challenges for regulatory work, and new business concepts such as sharing and group buying also pose new issues for regulatory work.

Taking the regulation of online medical device sales as an example, for business models that use computers and Mobile phones to conduct sales, regulatory departments find it difficult to analyze sales using existing manpower and material resources. Moreover, in regulating online sales of medical devices, there is currently a lack of effective investigation and evidence-gathering methods.

Delivering a Combined Regulatory Approach

Solidifying the Foundation of Regulatory Work

Solidifying the foundation of regulatory work is crucial for effective medical device regulation in the new context. This can be achieved by focusing on improving the regulatory legal framework, strengthening regulatory workforce development, and advancing regulatory informatization.

Improving the Regulatory Legal FrameworkThis year, the National Medical Products Administration has actively promoted the revision of the "Medical Device Supervision and Administration Regulations." Taking this as an opportunity, promoting the improvement of the relevant regulatory framework will help enrich supporting regulatory measures and ensure that medical device regulatory work operates within the rule of law.

Improving the Professional Level of the Regulatory Workforce.In the face of constantly changing regulatory needs, the capabilities and quality of the regulatory workforce must match. Regulatory departments can regularly conduct professional training through lectures, on-site training, and learning through inspection to improve the professional level of regulatory personnel.

Accelerating the Development of a Professionalized and Specialized Inspector Workforce.In July of this year, the General Office of the State Council issued the "Opinions on Establishing a Professionalized and Specialized Pharmaceutical Inspector Workforce," which points out that professionalized and specialized pharmaceutical (including medical devices and cosmetics) inspectors are an important force in strengthening drug regulation and ensuring drug safety. The document also clarifies that by the end of 2020, the State Council's drug regulatory departments and provincial drug regulatory departments will have basically completed the construction of the institutional framework for a professionalized and specialized pharmaceutical inspector workforce.

We can supplement the inspector workforce through coordinating existing regulatory personnel within regulatory departments, training relevant professionals, and publicly recruiting from society, strengthening the development of a professionalized and specialized inspector workforce.

Promoting Regulatory Informatization.Achieving interconnectivity and resource sharing among regulatory departments is essential for improving regulatory efficiency. We should continue to promote the informatization of medical device regulation, researching and establishing a standardized medical device traceability system to improve information-based regulatory capabilities.

Establishing a Unique Identification System for Medical Devices.Unique identification should be implemented in the production and circulation of medical devices, exploring and establishing a full-chain regulatory information linkage mechanism from production to clinical use.

Strengthening Enterprise Primary Responsibility

Regulatory departments should increase publicity and training on newly issued regulations and continuously strengthen the sense of primary responsibility of enterprises.

Against the backdrop of the continuous expansion of the pilot program for the medical device registrant system, regulatory departments should make good use of this opportunity to strengthen the legal responsibility of medical device registrants for medical device product design and development, clinical trials, manufacturing, sales and distribution, After-sale Service, adverse event reporting, etc., while ensuring that the materials and clinical trial data submitted by registrants are true, complete, and traceable. In addition, they should also urge continuous research on products already on the market and promptly report adverse events.

Implementing Full-Process Regulatory Responsibility

Regulatory departments should strengthen the supervision of medical device manufacturers, distributors, and users. In supervising manufacturers, fully implement the "Medical Device Production Quality Management Specifications." For Class I and Class II medical device manufacturers, a certain proportion of enterprises should be selected for inspection based on the "double random, one open" principle. For enterprises with complaints, reports, or unqualified inspections, thorough inspections must be conducted to eliminate product quality risks. In addition, supervision of used and donated or transferred medical devices also needs to be strengthened.

Regulatory authorities should also strengthen the supervision of the quality of medical device use. This can be achieved through enhanced cooperation with health and health departments to establish a joint working mechanism for daily supervision, risk prevention and control, spot checks and inspections, and adverse event monitoring of medical device use quality, thereby forming a joint regulatory force.

In addition, relevant regulations on the supervision and administration of agents for imported medical devices should be implemented. Supervision and administration of agents for imported medical devices should be strengthened, and a quality management system should be established. Regulatory requirements should be put forward for aspects such as adverse event monitoring and product recalls to ensure product traceability.

Improve risk prevention and control work

Regulatory authorities should strengthen the supervision of key products and key links, increasing supervision of product raw materials, newly established enterprises, and products with special storage and transportation requirements, effectively achieving strict prevention at the source and strict control during the process.

Medical device spot checks are also a key area of supervision that should be focused on. The types of products to be spot-checked should cover key products under supervision and those that failed inspections in previous years. Meanwhile, regulatory authorities should publicize the results of spot checks and the disposal of substandard products and regularly issue quality announcements. For substandard products identified in spot checks, targeted actions should be immediately launched, and enterprises suspected of violating laws and regulations should be investigated and dealt with in accordance with the law.

Meanwhile, the monitoring of adverse events related to medical devices should be further promoted, improving monitoring effectiveness, and urging medical device production, operation, and use units to proactively conduct monitoring. While ensuring the number of adverse event reports, the quality of reports should also be improved.

Monitoring should be conducted on key product varieties, analyzing product risks and proposing risk control measures to provide technical support for the safe use and supervision of medical device products.

In addition, the advantages of third-party professional certification bodies should be further leveraged. Their assistance should be used to identify deeper risks, and effective measures should be taken to promote the implementation of quality management standards. Third-party system audits can also be explored, improving the scientific and professional level of medical device supervision through the organic linkage of supervisory inspections and professional audits.

Conduct special rectifications targeting key issues

Regulatory authorities should also conduct special rectifications targeting key issues. Specifically, supervision of the production, operation, and use units of sterile and implantable medical devices should be further strengthened.

Meanwhile, inspection work should be done well, strictly adhering to the requirements of the "Methods for Inspection of Drugs and Medical Devices," and enterprises with problems found during inspections should be dealt with according to law.

In addition, investigation and handling of major cases should be done well, strengthening the efforts in investigating and handling cases, digging deep into the root causes of cases found in daily supervision, and forming a joint force with the public security department to strengthen the connection between supervision and inspection and law enforcement.