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Common FAQ

Whether The Documents Of Comparable Medical Device(s) Must Be Authorized By Its Administrative Counterpart?
According to the “Guidance for Clinical Evaluation of Medical Devices” (General Notice No. 14 of 2015), the requirements for conducting clinical evaluation by the method of using comparable device(s) is clear that the relevant data should be acquired legally. The “Notice of NMPA on Issuing Implementation of Provisions for Medical Devices and In Vitro Diagnostic Reagents Registration” (Food and Drug Administration [2015] No. 247) mentions that, if a device which belongs to another administrative counterpart is chosen as a comparable device, and the manufacturing technique information, clinical data and other information of comparable device(s) are used, the administrative counterpart need to submit an authorization when conducting clinical evaluation accordance with Article 6 of the “Guidance for Clinical Evaluation of Medical Device”. The “Interpretation Provisions for Medical Devices Registration No. 5”further interprets the medical device clinical evaluation data authorization requirements, which is, the authorization is required to ensure the legality of the data source when non-public data of comparable medical device(s) is used; The use of public publication data, such as published literature, public data and information, etc., authorization is not required. Therefore, when conducting clinical evaluation by the method of using comparable device(s), if the device(s) of other administrative counterpart is chosen as comparable medical device, and the data sources from publi
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What Is The Difference Between Username + Password Login Mode And Digital Certificate + Password Login Mode In ERPS System?
The eRPS system introduces a digital certificate login method to ensure the uniqueness of user authentication for registered electronic filing and the security of data transmission. The login method of user name + password can realize the submission of electronic filing matters offline and the declaration of electronic filing matters that have not been opened yet (renewal of registration certificate and change documents, correction, self^cancellation, self-revocation, designated inspection of medical device registration). The digital certificate + password login method can realize the online submission and electronic document inspection of electronic declaration matters.
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How To Check The Application Progress Of The Electronic Filing Through The ERPS System?
On the basis of the existing progress inquiry method, the e-declaration matters are carried out through the eRPS system. The contact person filled in the application form of the matter can receive SMS and email status update reminders. In addition, corporate users can also log in to the eRPS system to see if the status of the item has been updated.
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Is It Necessary To Classify A Newly Developed Medical Device That Has Not Been Included In The Classification List Before Registration?
According to Article 16 of the “Regulations on the Supervision and Administration of Medical Devices”,: For newly developed medical devices that have not been included in the catalogue, the administrative counterpart can directly apply for product registration in accordance with the provisions of these regulations regarding the registration of III medical device products. Alternatively, after judging the product category according to the classification rules and applying to the drug regulatory department for category confirmation, the administrative counterpart can apply for registration or filing in accordance with the provisions of these regulations.
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How Do I Prepare A PDF Version Of The Registration Application?
It is recommended to use PDF files formed from source files (such as WORDAVPS files) as much as possible. For example, WORD files can be converted to PDF format. If the registration application materials contain documents that cannot be accessed from electronic sources or require a third-party signature, this part of the materials can be submitted as PDF files created by scanning paper documents.
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What Is The Definition And Construction Principle Of The Target Value In The Design Of Single-group Target Value Clinical Trials?
The target value is the recognized minimum criteria of the effectiveness/safety evaluation indexes for certain types of medical devices, including objective performance criteria (OPC) and performance goal (PG). The target value is usually a two-category (such as valid/invalid) indicator or a quantitative indicator, including the target value and the one-sided confidence interval limit (usually 97.5%). In a single-group clinical trial, the effectiveness/safety of the device in question is evaluated by examining whether the results of the main evaluation indicators are within the range of target value. Thus, a clinically meaningful target values needs to specify in advance. Because there is no control group, a single-group target value design clinical trial cannot confirm the superiority, equivalent, or non-inferiority of the device in question. It can only confirm that the effectiveness/safety of the device in question meets the recognized minimum criteria. The construction of target values usually requires comprehensive collection of clinical research data with a certain level of quality and a considerable number of cases, and scientific analysis (such as Meta analysis). With the improvement of device technology and clinical skills, OPC may change, and clinical data needs to be re-analyzed to confirm. When considering statistical analysis, the point estimates and the one-sided confidence interval limits for the primary evaluation indicators need to be calculated and compared
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What Should I Pay Attention To When Uploading PDF Files?
As far as possible, the applicant should control the PDF file of a single electronic registration report within 100MB, and multiple PDF files can be uploaded under the same directory title. It is recommended that the reading order of the materials under this title be reflected by the file name. For online submission, PDF files need to be signed by the CA signature of the company and successfully verified by the eRPS system before uploading automatically.
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What Are The Principles For Selecting Devices For Control Group In Parallel Controlled Clinical Trials?
For the therapeutic products, when selecting the positive control, it is preferred to choose approved similar devices that have clinically recognized efficacy and safety. If there are reasonable grounds that cannot select an approved similar device, then firstly, an approved device which is as similar to the device in question as possible can be chose as a positive control. Secondly, the standard treatment methods can be considered, which include multiple situations, such as medications. When the test device does not have the same or similar marketed products or corresponding standard treatment methods, the trial design needs to consider the comfort control if there is a comfort effect in the efficacy of the test device. At this time, ethical factors need to be considered comprehensively. If the efficacy of the marketed product has not been clinically recognized, the trial design can consider standard treatment methods or comfort control according to the specific situation, and the administrative counterparts should fully justify the selection of the control.
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How To Understand The Suggestions About Font Size In The Materials In The “Technical Guide For Electronic Submission Of Medical Device Registration Applications (Trial)”?
The technical guide describes the layout format including the font size, such as the font size is not less than four characters, the form text is not less than five characters, etc., which is only as a recommendation. The administrative counterpart should ensure that the electronic information submitted is clear and readable. If the format requirements for some materials are specified in the relevant guidelines, the corresponding requirements shall be complied with in the preparation of such materials.
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Does The Approval Of The Clinical Trial Application Also Approve The Clinical Trial Plan?
The aim of the clinical trial approval for class HI of high- risk medical device is to make a decision on whether to agree to conduct a clinical trial based on the application. The purpose is to protect the rights and interests of the subjects. The review focuses on preclinical research, clinical benefit and risk analysis of the product. The design of clinical schemes may affect the risks and benefits of clinical trials to subjects. Therefore, clinical trial plans are one of the review contents of clinical trial approval applications. However, the clinical trial approval process does not finalize the clinical trial plan submitted by the administrative counterpart. The administrative counterpart can refer to the communication with the review and approval personnel during the clinical device approval and registration process of the medical device, and modify and improve the clinical trial plan in accordance with the requirements of the GCP. The technical review agency will give a comprehensive evaluation of the safety and effectiveness of the product in the subsequent review and approval process.
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How To Add Page Numbers To Documents In ERPS System?
The page number of a single PDF file should have the correct and unique identification, to ensure that relevant information can be located through the page number. Each PDF file should be paged. The page number is recommended to reflect the directory number information where it is located. It should be clear and legible, and it is recommended to be in the middle of the bottom of the file. PDF files created after scanning can be paged by marking page numbers on paper.
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If All The Individual Test Items In A Joint Detection Reagent Of Multiple Analytes Are In The Catalogue Of IVD Reagents Exempted From Clinical Trials (hereinafter Referred To As The “catalogue”), Can The Multi-analyte Joint Detection Reagent Be Considered As A Product In The Catalogue?

If the applicant can prove that the different individual test items do not interact with each other in the joint detection reagent and the intended use does not exceed the scope of the exemption catalogue, it can be considered the multi-analyte joint detection reagent is just a simple joint of several exempted reagents, and the performance of each test item can be evaluated separately in accordance with the clinical evaluation requirements as the product of the Catalogue. It is worth noting that the applicant should confirm that these test items have a clear significance of joint testing and the additional risks produced by the combination should be evaluated. At the same time, if it has a new clinical significance, the multi-analyte joint detection reagent should not be considered a product that complies with the Catalogue.

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