Policy Interpretation —— How to Enter the “Fast Track” of Priority Approval？
Policy Interpretation – How to Enter the "Fast Track" of Priority Approval? ——This policy was implemented on January 1, 2017 1. Scope of priority approval Projects those are applicable to the priority approval of "fast track" a. Applications for registration of domestic Class III medical devices. b. Applications for registration of imported Class II and Class III medical devices. Projects those are not applicable to the "fast track" of Priority Approval a. Filing of Class I medical devices; b. Applications for registration renewal and registration change; c. Applications that have been included in the approval process in accordance with the emergency approval procedures for medical devices or the special approval procedures for innovative medical devices. 2. The conditions for applying for priority approval (1) Diagnose or treat rare diseases, with obvious clinical advantages. (2) Diagnose or treat malignant tumors, with obvious clinical advantages. (3) Diagnose or treat specific and multiple diseases to the elderly, and there are currently no effective diagnoses or treatments. (4) Dedicated to children, with obvious clinical advantages. (5) Clinically urgently needed, and for which there are no registered medical devices of the same species in China. (6) Medical devices listed in major national science and technology projects or national key research and development programs. (7) Other medical devices that should be prioritized for approval, shall be determined by NMPA after extensively soliciting of opinions and organizing experts to demonstrate. 3. When is the priority approval application submitted? Those who meet the above priority approval conditions shall submit the application for priority approval together with the registration application for medical devices.
Statistics on the Clinical Trial Data of Quantitative Detection Products of In Vitro Diagnostic Reagents
For quantitative detection products, appropriate statistical analysis methods such as regression analysis should be selected according to the detection performance of the products for clinical trial results. Within a reasonable confidence interval, investigate whether there was a significant correlation and whether there is a significant statistical difference in the results of quantitative values. If possible, the recommendation should be taken into account that the possible differences in the performance of reagents in different sample concentration intervals, the overall concentration range is subject to interval stratified statistics, and the results in different concentration intervals were analyzed for correlation to better verify the correlation between the two reagents.
What Data Should be Submitted to Prove the Hemostatic Mechanism of Absorbable Hemostatic Products in China?
In order to prove the hemostatic mechanism of absorbable hemostatic products in China the applicant must submit technical or supporting data that can effectively prove or explain the principle of hemostatic action of the declared product. It must: clarify the hemostatic mechanism of the declared product in detail, describe how the product affects the hemostatic process, the advantages of the product in the hemostatic process, and confirm whether the application of this hemostatic mechanism combined with the declared product is scientific and reasonable. The applicant must review the domestic and foreign research literature supporting the hemostasis principle, and submit the original text and Chinese translation of the relevant scientific literature specifically supporting the hemostasis principle. The applicant must also clarify whether there are products applying the same hemostasis principle on the domestic and foreign markets, and also study whether the declared product may cause thrombosis, coagulation disorders, and other adverse reactions related to its use.
Regulations on the Reference of Clinical Trial Data in China
1 Whether the non-Chinese clinical trial data of the product must fully meet the requirements of the corresponding Chinese guidelines or not? 2 Can I select similar products as the control products according to Chinese regulations? 3 Is it necessary to include the Chinese trial data in the non-Chinese clinical trial data ? 4 Are the medical devices required to carry out clinical trials in China?
Is It Possible to Choose A Single-group Target Value Design for Clinical Trials of Intracranial Drug-coated Balloon Dilatation Catheters？
A single-group target value design can be considered when test device is technically mature and the disease for which it is intended is well understood, or when it is objectively infeasible to set up a control group We recommend choosing RCT trial design for clinical trial, according to technical development and clinical application status of intracranial drug-coated balloon dilatation catheter, which does not conform to the basic principle of single-group target value design.
What are the Requirements for Anticoagulants Used in Clinical Trials of In Vitro Diagnostic Reagents?
When different anticoagulants are involved in the test samples of in vitro diagnostic reagents, different anticoagulants should be studied in the preclinical research stage to verify the applicability of anticoagulants and their impact on the test.
About the Measurement Function in the Medical Device Software, What Issues Should be Concerned About in the Registration Application Data?
Registration applicants are required to provide research data on measurement accuracy and inform users in the instructions.
Guideline on Market Access for Medical Device in China
Guideline on Market Access for Medical Device in China is a report drafted by CIRS Group- Medical Device BU to help companies and individuals who would like to sell their medical devices to the People’s Republic of China and get their medical device products registered with NMPA. The guide describes key definitions, main regulations, authorities of the medical devices in China, and also the requirements of the whole life-cycle of medical devices including pre-registration preparatioin, registration process, testing/inspection, clinical evaluation, QMS and post-market management.
Precautions and Registration Preparations for Radio Frequency Beauty Products Transferred to Medical Devices
On April 16, 2021, the National Medical Products Administration released the "Guiding Principles for the Classification and Definition of Radio Frequency Beauty Products" for comments on the solicitation of "Guidelines for the Classification of Radio Frequency Beauty Products". According to the definition of the properties of the draft, it claims that radio frequency beauty can reduce spots and wrinkle. Such equipment is classified as medical device management. Medical devic
Common Technical Issues of Active Medical Device 3
Q: How to determine the servicelife of active medical devices? what factors should be considered? A: The manufacturer should dynamically evaluate the service life of the product through risk analysis in the whole life cycle of the product. When there is no unacceptable risk within the service life of the product after listing, the expected service life determined before listing can be maintained; or the expected service life determined before listing can be extended after re