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For medical device supervision, 2020 is has been a year full of challenges and hopes. Over the past year, a host of important policies have been successively issued, significant breakthroughs have been made in emergency approvals, and various innovations have come into being… Let us look back together on our extraordinary journey in medical device supervision in 2020.

01 The pace of emergency review and approval of medical devices has been accelerated in our efforts to prevent and control the pandemic.

After the outbreak of Covid-19, the Center for Medical Device Evaluation of National Medical Products Administration launched an emergency review procedure on January 21. The reviewers intervened in advance and responded to emergencies 24 hours a day to provide advanced services for registration applicants for product development and registration. On January 26, some coronavirus nucleic acid detection reagents began to be approved in China; on February 22, coronavirus antibody detection reagents began to be approved, and these agents can meet needs of our efforts to combat the pandemic. In addition, other medical equipment used for emergency approval for the purpose of pandemic prevention and control, such as gene sequencers, ventilators, and constant temperature amplification nucleic acid analyzers, have also been approved.

02 Several artificial intelligence medical devices were approved for marketing.

This year, China has seen great breakthroughs in the approval of artificial intelligence medical devices. In January, Beijing Kunlun Medical Cloud Technology Co., Ltd. obtained the first artificial intelligence class III medical device registration certificate for its fractional flow reserve computational software; in February, the AI “ECG analysis software” of Lepu Medical was registered and approved; in June, the MR imaging-assisted diagnosis software for intracranial tumors was approved as Class III medical devices; In July, the AI “ECG machine” of Lepu Medical was approved; In August, the innovative product “Diabetic retinopathy fundus image-aided diagnosis software” produced by Shenzhen Siji Intelligent Technology Co., Ltd. and “Diabetic retinopathy analysis software” produced by Shanghai Yingtong Medical Technology Co., Ltd. were approved for listing. As of December 16, a total of 10 artificial intelligence medical device products have been approved for listing.

03 Provisions on the Administration of Extended Clinical Trials of Medical Devices (for Trial) Promulgated

On March 20, the National Medical Products Administration and the National Health Commission jointly issued the Provisions on the Administration of Extended Clinical Trials of Medical Devices (for Trial), allowing products that is beneficial in preliminary clinical observations but have not yet been approved for marketing, to used for critically ill patients who have no effective treatment, provided that informed consent is obtained and ethical review is conducted. In addition, the safety data of extended clinical trials of medical devices is allowed to be used for registration application.

04 China’s First medical device product using domestic real-world data approved for marketing

On March 26, the National Medical Products Administration approved the registration of the “Glaucoma Drainage Tube” of Allergan of the United States. This product uses clinical real-world evidence collected in the Hainan Boao Lecheng Pioneer Area for the evaluation of ethnic differences, becoming the first domestic product approved through this channel.

05 2020 Hunting Convicts Online Initiative for Medical Devices Issued by The National Medical Products Administration

On April 29, the National Medical Products Administration issued 2020 “Hunting Convicts Online Initiative” for Medical Devices, which requires that the initiative should be conducted both “online” and “offline” and information and product should be integrated. The initiative also emphasized that third-party platform for online medical device transaction services should be held accountable for managing such transactions and the primary responsibility should lie with online sales enterprises for medical devices. Drug regulatory departments shall be responsible for supervision of devices sold within their territory, the monitoring of medical device online transactions should be intensified, and violations of laws and regulations should be severely published.

06 Pilot Work Unique Device Identification (UDI) System Advancing Steadily

On July 24, the National Medical Products Administration held a meeting to promote the pilot work of the unique device identification (UDI) system, periodically summarize the progress and effectiveness of the pilot work for UDI system, and facilitate in-depth development of the pilot work. On September 29, the National Medical Products Administration, the National Health Commission and the National Healthcare Security Administration jointly issued a document to extend the pilot period of UDI system for medical devices to December 31, 2020. The extension for the first batch of 9 categories and 69 varieties of Class III medical devices will be implemented on January 1, 2021.

07 Pilot Application of Electronic Registration Certificate for Medical Devices by National Medical Products Administration

On October 19, the National Medical Products Administration issued the Announcement on Pilot Application of Electronic Registration Certificate for Medical Devices, and decided to issue electronic registration certificates for medical devices on a pilot basis starting from October 19, 2020. The pilot period will start from October 19, 2020 until August 31, 2021. The scope of medical devices qualified to receive such certificates include Class III domestic medical devices and imported Class II and III medical devices that are first registered. Certificates for changes and renewals of registration will be issued gradually depending on the actual situation.

08 The First National Medical Device Safety Promotion Week Held

From October 19 to 25, National Medical Products Administration held the First National Medical Device Safety Promotion Week on an nation-wide scale. Centered on “promoting the main theme of reform and innovation and improving new drivers of industrial development”, the event adhered to a demand-oriented and problem-oriented principle, and carried out its publicity efforts in many aspects. During the event, drug regulatory departments in various worked in tandem and enhanced the awareness of the public about medical devices by holding a diversified range of activities.

09 Technical Guidelines for Using Real-World Data for the Clinical Evaluations of Medical Devices (for Trial) Promulgated

On November 26, the National Medical Products Administration issued the Technical Guidelines for Using Real-World Data for the Clinical Evaluations of Medical Devices (for Trial) which defines key concepts such as real world data, real world research, and real world evidence. The guideline proposed 11 common situations in which real-world evidence is used in clinical evaluation of medical devices and clarified the path of real-world data used in clinical evaluation of medical devices, thus broadening the sources of clinical data.

10 The National Food and Drug Administration Arranged to Strengthen Quality Supervision of Coronary Stents Selected in Centralized Procurement

In November, the state organized centralized procurement of coronary stents. On November 11, the National Medical Products Administration issued a notice to strengthen the quality supervision of selected coronary stents in national centralized procurement; On November 25, the National Medical Products Administration organized and convened a video conference on the quality and safety supervision of selected coronary stents in national centralized procurement to step up the quality and safety supervision of selected products; On December 10, Xu Jinghe, deputy director of the National Medical Products Administration , led a supervision and investigation team to investigate the production quality management of two selected coronary stent manufacturers in Beijing.

Source:China association for medical devices industry