NMPA Requirements for Post-Market Surveillance(PMS) of Medical Devices
Medical devices, whether directly or indirectly used in human body, are closely related to human health. In China, Post-Market Surveillance (PMS) is an important part of medical device safety and efficacy regulation, which is supervised by NMPA ((National Medical Products Administration). It has become a focus of attention how to effectively conduct post-market surveillance of medical devices to protect people’s health. We summarize some of the requirements for post-market surveillance of medical devices in China.
According to GB/T 42061-2022 Quality Management System for Medical Devices For Regulatory Requirements, post-market surveillance is a systematic process of collecting and analyzing the experience gained from medical devices that have been marketed.
Although this definition has less than thirty words, it covers a wide range of aspects such as quality management system, professional guidelines, product standards, design control, supervisory personnel qualification and competence as well as related technologies. Therefore, for medical device registrants/filers, post-marketing surveillance is a difficult and long-distance task. In order to do post-market surveillance well, the following aspects are essential:
Establishing a Quality Management System
The rapid growth of the medical device industry in recent years has triggered an increase in post-market regulatory requirements for medical devices in various countries and regions. The core objective of these regulatory requirements is to ensure the safety and efficacy of medical devices, emphasizing that medical devices must meet customer needs and regulatory requirements. The purpose of these requirements is to guide medical device companies to develop in the direction of greater scale, systemization, and standardization in order to enhance and safeguard the quality of medical devices.
Therefore, in order to ensure the safety and efficacy of medical devices globally, the first task is to fully understand and translate these regulatory requirements into the internal quality processes of medical device companies. The establishment and improvement of a quality management system can effectively guide post-market regulatory activities in a more systematic and standardized manner.
Strengthen the regulatory measures for enterprises
According to the data of the 2022 Annual Report on National Medical Device Adverse Event Surveillance published by the National Center for Adverse Drug Reaction Monitoring (NCADRM) of China, a total of 153 Suspected Adverse Event Reports (SARs) involving deaths were received in 2022, accounting for 0.02% of the total number of reports; 45,012 Suspected Adverse Event Reports (SARs) involving serious injuries were received, accounting for 6.48% of the total number of reports; and 649,701 suspicious adverse event reports involving other injuries, accounting for 93.50% of the total number of reports. These data show that even if companies have identified relevant risks during the design stage of medical devices, there may still be potential risks during actual use.
Therefore, incorporating regulatory requirements into an organization’s internal quality management system is the first step in post-market surveillance. However, the actual implementation of post-marketing surveillance is even more challenging, requiring companies to combine theory and practice, continuously and proactively collect and identify risks that may exist during the use of medical devices, and combine with their internal quality management system to continuously improve the effectiveness of surveillance. The main regulatory measures include but are not limited to：
① Active collection of information
The medical device registrant filer should take the initiative to collect written, electronic or verbal feedback on the existence of defects related to marking, quality, durability, reliability, usability, safety or performance of medical devices that have been released from organizational control, or claimed that there are deficiencies in the services affecting the performance of these medical devices. At the same time, it should also make full use of information technology supervision means, all-round, multi-angle proactive identification of external accessible information, to provide resources for post-market supervision of enterprises.
Information is collected through avenues including, but not limited to:
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- Feedback on service processes such as product repair/maintenance;
- Feedback from service activity records;
- Feedback on key findings from post-marketing clinical follow-up reports;
- Feedback from customers, users, patients;
- Feedback from service activity providers;
- Adverse events, cyber security incidents or recalls notified by external organizations.
② Effective assessment of information
The medical device registrant filer should designate personnel to organize review and assessment of the information that has been collected, using appropriate quality tools (such as 5Why, fishbone diagram, fault tree, etc.) to conduct investigations and problem analysis in order to find the root cause, fully and effectively identify the hazards and hazardous conditions associated with the medical device to assess the existence of the following conditions, so as to achieve the main purpose of prevention and corrective action:
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- Assess the presence of adverse events, i.e., all kinds of harmful events that occur under normal use and lead to or may lead to human injury.
- Assess the presence of trend reporting by analyzing whether there is a statistically significant increase in the frequency or severity of collected non-serious events or expected adverse side effect events that could have a significant impact on the benefit-risk analysis.
③ Robust implementation of measures
Through the investigation, analysis and assessment of the identified medical device risks, the enterprise shall take reasonable and necessary control measures, and when taking measures, it is appropriate for the enterprise to consider:
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- Those that have been distributed (i.e. beyond the control of the enterprise) need to consider whether they need to be corrected or removed (recall, advisory notice, etc.);
- Those that have been manufactured but not distributed (i.e. still under the control of the business) need to consider whether production and shipments need to be stopped;
- Those that to be manufactured in the future need to consider the need to improve the design of the medical device and related manufacturing processes.
Enhancing Communication with Regulatory Agencies
Medical device companies should truthfully report compliant adverse events or trend reports to the relevant regulatory agencies in a timely manner in accordance with applicable regulatory requirements. At the same time, medical device companies are also required to obtain any external adverse event information released by regulatory agencies in a timely manner, and organize relevant personnel to conduct investigations and analysis, and provide timely feedback of the assessment results to the regulatory agencies to ensure two-way communication of information.
Post-market surveillance is designed to ensure that medical devices continue to operate safely and effectively, and also to prevent the risks of using a medical device from outweighing the benefits it provides. Post-market surveillance is an important part of the quality system requirements, along with vigilance systems, economic operators and device registration.
HMK has completed quality system upgrades for many domestic and international medical device manufacturers or in vitro diagnostic manufacturers.
We can provide services below:
Post-market regulatory
Post-market performance/clinical tracking program PMPF\PMCF Plan
Periodic Risk Evaluation Report
Adverse Event Reporting
