TX Q&A

For newly developed in vitro diagnostic reagents and their supporting dedicated instruments, as they fall under different regulatory management, separate registration applications need to be submitted. However, the verification and confirmation of the testing performance of the reagents and their dedicated instruments are integral parts of the overall validation process. Therefore, when both the reagent and the instrument are finalized, the order of market entry for the reagent and its supporting dedicated instrument is not restricted. When applying for reagent registration, it should be ensured that the dedicated instrument and the detection system are finalized. If instruments produced by other companies are used, these supporting instruments should already be on the market as medical devices in China, and comprehensive verification and confirmation of their performance on these supporting instruments should be possible.

Applicants should establish extraction limits in accordance with the requirements of the extraction test in GB11417.3 and provide evidence, recommending reference to the "Notice on Relevant Issues in the Evaluation of Contact Lens Products" published on our center's website in 2016 and the document "Interpretation of the Expression of 'New Materials' in the National Standard Series GB11417 'Ophthalmic Optics Contact Lenses' and the Applicable Tests" issued by the National Medical Optics and Instrumentation Standardization Sub-Technical Committee in 2017. It is suggested to submit extraction research reports for the declared products. If you intend to submit extraction research reports for similar products as a basis, it is recommended that the formulations of both products are similar, such as only having differences in dye content, and it is not advisable if there is a significant difference between the formulations of the comparative product and the declared product. Additionally, it is recommended to demonstrate the similarities and differences between the selected product and the declared product, discussing aspects such as raw material formulations, product dry weight, and the wearing period of the product, analyzing whether these differences affect the results of the extraction study. Finally, attention should be paid to reasonably establishing the upper limit of the extraction rate.

Synthetic resin teeth are mainly made from acrylic ester polymers and are used in the production of partial and full dentures, replacing missing or damaged teeth to form an artificial dental arch, restoring the external shape of teeth, and chewing function. Products with different main chemical compositions should be divided into different registration units, while products with only different color shades can be declared as a single registration unit. Products with different key production manufacturing processes and forming methods should be divided into different registration units (such as compression molding, injection molding, 3D printing, CAD/CAM, etc.). Products with different key performance indicators due to different modification mechanisms from traditional materials should be divided into different registration units (e.g., surface hardness, wear resistance, etc.). Products with different clinical application technologies should be divided into different registration units.

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."

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.

The version number of the software used in conjunction is a permitted item in the equipment registration certificate and cannot be changed during the renewal of registration. If the equipment needs to be used with a newer version of the software, a registration change should be applied for, and during the change in registration, the safety and effectiveness of the software used in conjunction should be demonstrated. If no changes are made, the equipment cannot be used with the new version of the software but can still continue to be used with the previous version of the software.

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.

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.

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.

Referring to the "Guiding Principles for the Division of Medical Device Registration Units," active medical device accessories used in conjunction with the main device are generally declared as the same registration unit. The fluid reservoir is not managed separately as a medical device; it is recommended to declare it in the same registration unit as the therapy device. Referring to the "Guiding Principles for the Division of Medical Device Registration Units," passive consumables used in conjunction/combination with active medical devices are generally divided into separate registration units from the active medical device. Foam dressings used in conjunction are passive consumables; they should be declared in separate registration units from the therapy device.