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China will launch electronic registration and filing for medical devices
Release time:
2025-03-12 09:43
Xinhua News Agency, Beijing5month31Daily News (Reporter Zhao Wenjun) Based on the development of the medical device industry and the demands of enterprises, the National Medical Products Administration31released the "Technical Guidelines for Electronic Submission of Medical Device Registration Applications (Trial)", and will launch electronic medical device registration applications this year on6month24While retaining offline application submissions.
Sun Lei, director of the Center for Medical Device Technology Evaluation of the National Medical Products Administration, introduced that medical device registration and declaration is necessary regulation for medical device products before they Enter the market. After the online launch of electronic declaration, it will help to improve"Internet+Medical Device Government Services"Informationization level, saving time for the flow of medical device registration materials, reducing the burden of declaration for administrative counterparts of medical devices, effectively improving the quality of registration declaration materials, and optimizing review and approval services.
The technical guidelines released this time are formulated in accordance with China's medical device registration procedures and requirements, and refer to the relevant registration and declaration standards of international medical device regulatory agencies, and will be continuously upgraded and improved.
Sun Lei said that China is one of the member states of the International Medical Device Regulatory Forum. The adoption of the medical device registration and declaration standard catalog means that China's medical device supervision work is in line with international regulatory mechanisms. This is not only conducive to improving the efficiency of technical review, but also facilitates applicants to apply for listing internationally. Because electronic declaration has clear standards for declaration materials and detailed technical requirements, it is also conducive to improving the R&D level of enterprises.
According to the introduction, the National Medical Products Administration encourages applicants to submit electronic applications. This year, two public interest training sessions on the electronic application system for medical device registration have been held, with nearly800enterprises receiving training. Follow-up targeted training and guidance will be organized to effectively achieve the transition from paper to electronic materials. (End)
Launch, medical device, declaration, registration, electronic, supervision, technology, data, international, improvement
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