NMPA: Temporary Importation of Clinically Urgently Needed Medical Devices
I. This requirement applies to Class II and III medical devices that are temporarily imported and used by medical institutions due to clinical urgency for patients, are already marketed abroad but have no domestically approved equivalent product in China. It excludes equipment that should be included in the management of large medical equipment configuration licenses. Among them, clinical urgency refers to the need for clinical prevention and treatment of life-threatening diseases where there is no effective domestic treatment or prevention method. Equivalent products refer to domestically registered products that are substantially equivalent in basic principles, structural composition, main raw materials, production process, performance requirements, safety evaluation, compliant national/industry standards, intended use/scope of application, etc.
II. Medical institutions using the aforementioned medical devices shall be qualified Class III Grade A hospitals. Specific requirements are detailed in Appendix 1.
III. Medical institutions shall be responsible for the clinical use management of clinically urgently needed medical devices. Medical institutions, medical device operating enterprises, and overseas manufacturers or agents of medical devices shall sign quality agreements/agency agreements to clarify the quality and safety obligations and responsibilities of all parties, including compensation obligations and responsibilities.
IV. Medical institutions intending to temporarily import and use medical devices due to clinical urgency for patients shall submit the following application materials to the NMPA as required:
1 Application form;
2 Medical device-related materials;
3 Necessity assessment materials for medical device use;
4 Feasibility assessment materials for medical device use;
5 Certifying documents;
6 Letter of commitment.
Medical institutions shall ensure that the submitted materials are legal, authentic, accurate, complete, and traceable. Requirements and instructions for application materials are detailed in Appendix 2.
V. After receiving the application materials from the medical institution, the NMPA shall promptly organize technical review departments and experts to review and decide whether the corresponding medical device is already marketed abroad but has no domestically approved equivalent product, etc.
The NMPA may organize an expert group as needed to demonstrate whether the applying medical institution has the capacity for use management, whether the corresponding medical device is clinically urgently needed, and whether the quantity to be used is reasonable, through meetings, written reviews, or soliciting written opinions. The expert group shall consist of an odd number of members, not less than 7, including one group leader. Personnel from relevant units such as drug regulatory departments and health authorities may attend the expert demonstration meeting. The expert demonstration time is not included in the review time.
VI. If expert demonstration is conducted, the NMPA shall decide whether to allow temporary importation and use within 3 working days after receiving the written expert demonstration opinions.
If temporary importation and use are approved, the decision shall be made in the form of a letter from the NMPA General Office and copied to the National Health Commission, the provincial-level drug regulatory department where the medical institution is located, and the provincial-level health authority. If importation and use are not approved, the applying medical institution shall be notified in writing.
VII. The use of medical devices by medical institutions shall be reviewed and approved by the medical institution's ethics committee, and informed consent forms and other documents shall be signed with patients or their guardians in accordance with relevant national regulations.
VIII. Medical records generated by the use of medical devices shall be kept for 30 years, and other relevant data and materials shall be kept for the long term.
IX. If serious adverse events directly related to the medical device occur during its use, or if quality and safety hazards are discovered, the medical institution shall immediately stop using it.
X. Medical institutions shall promptly analyze clinical data of the medical device, assess risks, conduct safety and effectiveness evaluations of clinical use, and report the evaluation of temporary importation and use of the medical device to the provincial-level drug regulatory department where they are located annually. The provincial-level drug regulatory department shall notify the health authority at the same level.
XI. If, after using the medical device, the medical institution needs to continue using or increase the quantity due to clinical urgency for other patients, it shall resubmit an application in accordance with this requirement and use it only after approval.
XII. Medical institutions purchasing corresponding medical devices through medical device operating enterprises may have the operating enterprise apply for import customs declaration in one go based on the NMPA's reply letter.
XIII. Fees for temporarily importing and using clinically urgently needed medical devices shall be implemented in accordance with relevant regulations of the medical security department.
XIV. Provincial, autonomous regional, and municipal people's governments authorized and approved by the State Council to temporarily import and use clinically urgently needed medical devices shall carry out work in accordance with relevant regulations.
XV. This requirement shall take effect from the date of issuance.
foreign language materials shall be provided with the original text at the same time.
3 Unless otherwise specified, application materials shall be stamped with the official seal of the medical institution, and multi-page materials shall be stamped with a骑缝章 (seal across the page breaks).
4 The specific handling person shall submit a letter of authorization from the medical institution and a copy of their ID card.
