Medical devices urgently needed for clinical use in China have new draft requirements announced by the Center for Medical Device Evaluation (CMDE) on October 20, 2023:
- the management of temporarily imported medical devices that are urgently needed for clinical use
- criteria of eligible hospitals
- the information required for application submission
Public consultation on these draft documents ends on November 15, 2023.
Key insights
- Scope of Application: These requirements apply to medical institutions that need to temporarily import and use medical devices due to special clinical urgencies. The devices must be:
- marketed abroad already and not yet approved in China,
- used for treating life-threatening diseases without effective domestic alternatives,
- and not classified as large medical equipment.
- Hospital Criteria: Healthcare institutions must meet certain criteria, including being third-grade class A hospitals. These criteria are detailed in Appendix 1 of the document.
- Responsibilities: Hospitals, medical device distributors, and overseas manufacturers or agents must sign quality agreements outlining their responsibilities and obligations, including liability and compensation.
- Application Process: To request the temporary import of medical devices, hospitals must submit various documents, including an application form, relevant device information, necessity and feasibility assessments, supporting documents, and a commitment letter. These documents must be legal, accurate, complete, and traceable.
- Review Process: The China National Medical Products Administration (NMPA) reviews the application within 10 working days to determine if there are equivalent products available domestically.
- Expert Consultation: NMPA consults relevant experts and the National Health Commission within three working days to evaluate the hospital’s management capacity, clinical urgency, and usage quantity.
- Approval Decision: Within seven working days of receiving feedback from the National Health Commission, NMPA makes a decision on whether to allow importation. If approved, NMPA issues a formal letter to the hospital and informs relevant authorities.
- Ethical Review: Hospitals must obtain approval from their ethics committees and ensure informed consent from patients or guardians before using the imported devices.
- Record Keeping: Hospitals are required to retain medical records for these cases for 30 years, along with other relevant data.
- Adverse Event Monitoring: Hospitals must adhere to the “Regulations on the Monitoring and Reevaluation of Adverse Events of Medical Devices” and report any related severe adverse events promptly.
- Annual Evaluation: Hospitals must conduct an annual evaluation of the safety and effectiveness of the temporarily imported medical devices and report the results to local regulatory authorities.
- Continued Use: If the need for continued use arises for specific patients, hospitals must reapply following the same requirements.
- Procurement: Medical device distributors can apply for customs clearance with NMPA’s approval letter. Customs will verify and release the devices accordingly.
- Charges: Fees for the temporary import and use of urgently needed medical devices are regulated by the relevant healthcare authorities.
- Provincial Authority: In cases authorized by the State Council, provinces, autonomous regions, and municipalities directly under the Central Government can implement these requirements.
Hospital requirements
For hospitals to be eligible to apply for temporary importation, they must have a history of providing services in the relevant treatment area for difficult and critical illnesses, possess appropriate qualifications, and have specialized departments with experience in using similar medical devices. The hospital should also have an established quality management system suitable for the imported devices.
How to submit comments
If you have any comment, please send the email to ylqxzc@nmpa.gov.cn with the email subject of “urgent import use comments”.
Further information
Read the original CMDE article on clinical urgent import use of medical devices.
By adhering to the outlined requirements, manufacturers can ensure their products meet the necessary safety and performance standards. Also, Cisema can assist manufacturers in navigating the registration process effectively. Discover our services for medical device registration, renewals and NMPA Legal Agent.
