The relevant matters related to registration and declaration are announced as follows.
1、 The medical devices mentioned in this notice for the treatment of serious life-threatening diseases without effective treatment methods belong to a special situation described in Article 2 (1) of the "Medical Device Priority Approval Procedure" as "clinically urgently needed medical devices that have not yet been registered with the same variety of products in China". For medical devices used for the treatment of serious life-threatening diseases without effective treatment methods, the Medical Device Technical Evaluation Center shall give priority to the evaluation. If they meet the requirements of the "Guiding Principles for Conditional Approval of Medical Device Listing", they can be approved for listing with conditions.
2、 Medical devices that simultaneously meet the following conditions can be classified as medical devices that seriously endanger life and have no effective treatment methods for diseases:
（1） The product is expected to be used for the diagnosis and treatment of serious life-threatening diseases;
（2） There is currently no effective diagnosis or treatment method for this disease in China;
（3） The product has a clear working principle, well-designed design, and a certain theoretical and experimental foundation;
（4） Clinical trial data should be able to prove that the product has shown efficacy and can reasonably evaluate or judge its clinical value.
3、 For medical devices that meet the above conditions, applicants can apply for registration in accordance with the "Medical Device Priority Approval Procedure", and should also indicate that the product belongs to a medical device that seriously endangers life and has no effective treatment methods for diseases. In addition to the application materials required for priority approval, the applicant shall also submit materials supporting the product's compliance with the requirements of Article 2 of this notice, including:
（1） The clinical usage and current clinical application background of the product;
（2） The clinical value and relevant supporting information of the product;
（3） There is currently no evidence of effective diagnosis or treatment for the disease targeted by the product.
4、 In addition to the requirements of the Announcement on the Requirements for the Publication of Medical Device Registration Application Materials and the Format of Approval Documents and the Announcement on the Publication of in vitro Diagnostic Reagent Registration Application Materials and the Format of Approval Documents, applicants should also submit product registration application materials in accordance with the requirements of the Guiding Principles for Conditional Approval of Medical Device Listing.
5、 The Medical Device Technical Evaluation Center shall review the registered projects in accordance with the "Medical Device Priority Approval Procedure":
（1） Medical devices that have been reviewed and confirmed to be seriously life-threatening and without effective treatment methods for diseases, in addition to priority review and approval, may also be conditionally approved for listing in accordance with the requirements of the "Guiding Principles for Conditional Approval of Medical Devices for Listing".
（2） Medical devices that have been reviewed and confirmed not to be seriously life-threatening and without effective treatment methods, but meet the requirements of Article 2 (1) of the "Medical Device Priority Approval Procedure", shall be subject to priority review and approval in accordance with regulations, provided that the standards and procedures are not reduced.
6、 During the evaluation process, if communication and exchange work are involved, relevant regulations on priority medical devices shall be followed.
7、 If the product has passed the innovative medical device special