For the App (user analysis software) in the continuous glucose monitoring system product composition, if the Android version of the App is registered and an iOS version is added, is it necessary to register, test, and submit clinical data?
Adding an iOS version of the App requires testing in conjunction with the host device and submitting software research data for the iOS version of the App in accordance with the "Guiding Principles for the Technical Review of Medical Device Software Registration." If the software's functionality remains unchanged and only the operating environment changes, clinical data submission may not be necessary. Otherwise, clinical evaluation data must be submitted in accordance with the "Guiding Principles for the Clinical Evaluation of Medical Devices."
How should the registration units for artificial ligaments, artificial tendons, and artificial tendon membranes be divided?
Artificial ligaments are used to strengthen natural ligaments or for ligament repair, artificial tendons are used for tendon repair, and artificial tendon membranes are used for tendon membrane repair. Since they have different scopes of application and intended uses, they should be divided into separate registration units. Products made of different materials should be categorized into different registration units. If components of a product (such as screws for artificial ligaments) are made of different materials but are used as a whole assembly or in combination, they can be declared under the same registration unit.
When changes occur in medical devices, in what situations should their biocompatibility be reassessed?
Cases where the biocompatibility of medical devices needs to be reassessed include: (1) Changes in the source of materials or technological conditions used in manufacturing the product; (2) Changes in product formulation, processes, primary packaging, or sterilization; (3) Changes in the final product during storage period, such as alterations in storage period and/or transportation conditions; (4) Changes in the intended use of the product; (5) Signs indicating that the product may cause adverse reactions in the human body.
Can frozen samples be used in clinical trials of in vitro diagnostic reagents?
In clinical trials of in vitro diagnostic reagent products, case samples that meet the inclusion criteria need to be used for testing. When selecting specific samples for inclusion, attention should be paid not only to the selection of cases (see the common question "Common Issues Regarding Case Samples for Clinical Trials of In Vitro Diagnostic Reagents"), but also to the storage conditions of the samples. In principle, the use of clinical trial samples should closely match the status of samples during the clinical use of the reagent. For example, if samples are freshly collected for testing during clinical use, fresh samples should be considered for the clinical trial. If there may be sample storage processes during clinical use (such as freezing under certain conditions), and the instructions specify the corresponding sample storage conditions and expiration dates, samples under these storage conditions can also be included in the clinical trial. Whether using freshly collected samples or frozen samples, it is essential to ensure that the storage conditions and duration of the samples for inclusion comply with the requirements for storing the respective product samples.
If the applicant's name has changed and the report issued by a third-party organization shows the applicant's name as the previous name, can the report still be used?
The applicant must provide detailed documentation explaining the process of this change, along with supporting evidence. If it is merely a textual change in the name, the third-party report can still be used. If there has been a substantive change in the applicant, documents must be provided to prove that the current applicant can legally use the report. Additionally, an evaluation should be conducted to determine if this change has a substantive impact on the report's results.
What clinical evaluation data should be submitted for polyurethane foam dressings
For polyurethane foam dressings that meet the conditions of the "Revised Catalog of Medical Devices Exempt from Clinical Trials," applicants should submit comparative data between the declared product information and the content described in the catalog, as well as a comparative explanation of the declared product with domestically registered medical devices approved in the catalog and corresponding supportive data. For polyurethane foam dressings not within the scope of the exemption list, applicants should, while meeting the requirements of registration regulations, select appropriate clinical data of similar products according to the "Technical Guidance Principles for Clinical Evaluation of Medical Devices" for clinical evaluation and issue a clinical evaluation report as required by these guidelines. Applicants can also confirm the safety and effectiveness of the product's clinical application through clinical trials. If conducting clinical trials, considerations should include the purpose of the clinical trial, study population, selection of control groups (if necessary), sample size estimation, evaluation of assessment indicators and quantification methods, statistical analysis methods, and other related aspects.
How to execute modifications related to the "Interpretation of Labeling" section in the instructions for in vitro diagnostic reagents
According to the "Notice of the General Administration Office on Issues Related to Textual Changes in the Instructions for In Vitro Diagnostic Reagents" (Food and Drug Administration Equipment Management [2016] No. 117), textual changes in the informative content of instructions for in vitro diagnostic reagents can be modified by the registrant themselves, including the "Interpretation of Labeling" section in the instructions for in vitro diagnostic reagents. If the registrant improves the interpretation of corresponding labels in the instructions for in vitro diagnostic reagents according to the YY/T0466 series of standards, resulting in changes to this content but not involving other changes requiring permission, the registrant should make the modifications themselves. Here, the YY/T0466 series of standards refers to either the YY/T0466 series of standards or the corresponding ISO 15223 standard. If the registrant makes modifications themselves, they should provide an explanation upon renewal of registration.
Dental implant products registration units should be divided
Dental implants are medical devices implanted in the jawbone through surgical procedures to support denture restorations. Implants with different body materials should be classified into different registration units; implants with different surface treatment methods should be classified into different registration units; implants with different compositional structures should be classified into different registration units; implants with different forming processes should be classified into different registration units. Implant systems that must be used together inseparably to achieve the intended purpose can be declared as a single registration unit.
When specifying the applicable range of a membrane oxygenator based on different user weights, is it necessary to conduct separate clinical trials
If clinical trials are to be conducted for a registered product, it is recommended to conduct separate clinical trials for users with a weight >10kg and ≤10kg based on the specified applicable range of the membrane oxygenator. For manufacturers applying for registration of membrane oxygenators for users of different weights, it is suggested to first complete the registration of membrane oxygenators for users with a weight >10kg from a safety and effectiveness perspective. Once the product for users with a weight >10kg is on the market, then develop membrane oxygenators for users with a weight ≤10kg. Upon completing the technical documentation, risk management information, registration testing, etc., the number of clinical validation cases for membrane oxygenator products for users with a weight ≤10kg should be no less than 80 cases. When validating the population with a weight ≤10kg, a single-group target value trial design can be adopted.
If an imported product includes 10 optional configurations when marketed overseas, but only 3 are selected for sale in China, is this situation acceptable
When a foreign product is registered for application in China, the scope of the application should not exceed the approved scope overseas. If only a portion is declared, and that part can be independently applied while ensuring safety and effectiveness, reductions can be made to the approved scope overseas.