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.
Announcement on Relevant Matters Concerning the Production of Imported Medical Devices by Enterprises in China
On September 18, 2020, the National Medical Products Administration issued the Announcement on Relevant Matters Concerning the Production of Imported Medical Devices by Enterprises in China No.104 of 2020. The purpose was to further implement the State Council's Opinions on Reforming the Review and Approval System for Pharmaceutical and Medical Devices and Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices. As well as to implement the reform of "streamlined administration and delegated power, improve regulations, and upgrade services" and the requirements for optimizing the business environment, comprehensively deepening the reform of the medical device review and approval system, promote the high-quality development of the medical device industry, and better meet the public health needs. This article explains the announcement which covers the production of products with an imported medical device registration certificate in China:
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
Common Technical Issues of Active Medical Device 2
Q: What are the requirements for adding models or accessories in the Change of Permission Items? A: The contents contained in one registration certificate shall comply with the requirements of &quot;Guidance of registrtaion units division for medical device&quot;. Whether it is able to add models or accessories into the registration certificate of registered products depends on the difference between the new model and the original model, as well as the relevance between the new access
Analysis of Flight Inspection on Unqualified Medical Devices
In 2020, the National Bureau conducted unannounced inspections on 89 medical device manufacturers, including 44 IVD companies, 16 sterile product companies, 11 active device companies, 9 implant product companies, 3 denture companies, and 3 independent software company and 3 other companies. The reasons for unannounced inspections are compliance inspections, special inspections, unqualified random inspections, complaints and reports, and occurrence of adverse events. The res