The National Medical Products Administration (NMPA) and the National Health Commission (NHC) have jointly issued a new set of guidelines to regulate the temporary importation and use of urgently needed medical devices in clinical settings. This new regulation, Requirements for Temporary Importation and Use of Medical Devices Urgently Needed in Clinical Settings by Medical Institutions (医疗机构临床急需医疗器械临时进口使用管理要求), aims to address immediate clinical needs and ensure timely access to essential medical equipment, while adhering to safety and regulatory standards.
This announcement, effective as of its publication, outlines the procedural and administrative requirements for medical institutions to import and use medical devices that are critical for patient care but may not yet be registered or widely available in China. The guidelines align with the following key regulations:
- Regulations on the Supervision and Administration of Medical Devices (医疗器械监督管理条例) (Order No. 739 of the State Council)
- Administrative Measures for the Registration and Filing of Medical Devices (医疗器械注册与备案管理办法) (NMPA Order No. 47)
- Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents (体外诊断试剂注册与备案管理办法) (NMPA Order No. 48).
The purpose of these guidelines is to ensure that hospitals and other medical facilities can quickly obtain and use life-saving medical devices when conventional procurement processes would take too long or when no suitable alternative is available within the domestic market.
By streamlining the temporary import process, the NMPA and NHC hope to better meet clinical needs while maintaining rigorous oversight to ensure that patient safety is upheld.
This regulation is part of China's broader strategy to support the development and regulation of medical devices, helping to safeguard public health by enabling access to advanced medical technologies in times of urgent need.
Medical institutions are advised to follow the established procedures for importing these devices and to ensure compliance with all relevant regulatory guidelines.
Reference:
- Announcement of National Medical Products Administration and National Health Commission of the PRC on the Temporary Importation and Use of Medical Devices Urgently Needed for Clinical Purposes (No. 97 of 2024)
- Regulations on the Supervision and Administration of Medical Devices
- Measures for the Administration of Medical Device Registration and Filing