China Enhances Medical Device Registration and Supervision in 2023
China has made significant strides in improving the regulation and innovation of medical devices throughout 2023, showcasing advancements in legal frameworks, innovation approval rates, and international standardization.
Regulatory Framework Strengthening
On September 8, 2023, the Standing Committee of the 14th National People's Congress included the "Medical Device Management Law" in its legislative planning project. The National Medical Products Administration (NMPA) has established a leadership team, working groups, and expert advisory groups to draft the relevant legal texts. Collaborative efforts with the National Health Commission and the China CDC have led to the issuance of "Regulations on the Emergency Use of Medical Devices (Trial)," providing legal backing for the emergency use of medical devices.
Innovation and Quality Growth
The NMPA approved 61 innovative medical devices and prioritized 12, marking a new record in the number of innovative medical device approvals, a rise from 2022. Notable approvals include the world's first disposable pulmonary artery radiofrequency ablation catheter for treating pulmonary arterial hypertension and other products that meet international leading standards, fulfilling the public's need for high-end medical devices.
Support for Major National Strategies
China has continued to support the construction of key regions such as the Beijing-Tianjin-Hebei region, the Yangtze River Delta, the Greater Bay Area, the Hainan Free Trade Port, and Fujian. Initiatives include the approval of three products for the Hainan real-world clinical application pilot, totaling nine approved products benefiting a broader patient base.
Pandemic Control and Prevention
The emergency approval of three domestically produced Extracorporeal Membrane Oxygenation (ECMO) systems from companies in Guangdong, Beijing, and Jiangsu has bolstered health and severe disease prevention efforts. Throughout the year, 21 COVID-19 testing reagents were approved, summing up to 157 approved testing reagents to date, meeting the pandemic prevention and control needs effectively.
Registration and Record Management Improvement
Efforts to clean up and standardize the registration of Class II medical devices have been implemented, along with guidance for grassroots management of Class I medical device records, significantly enhancing registration and record management levels.
Clinical Trial Management Strengthening
The management of medical device clinical trials has been intensified, with authenticity verifications and supervisory spot checks doubling in number compared to 2022. The number of registered clinical trial institutions for medical devices reached 1,340 by the end of 2023, a 13.8% increase from 2022.
Standard Quality Enhancement
China has revised and published new guidelines for medical device standards, including the international standard ISO 24072 for infusion device bacterial retention testing, led by Chinese experts. The alignment with international standards exceeds 90%, demonstrating significant progress in standard quality enhancement.
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