TX Q&A

Applicants must submit the final version of the clinical trial protocol and informed consent form, along with the opinions of the ethics committee regarding each change. The final version of the clinical trial protocol should detail each modification made; if these changes are not detailed, then all versions of the clinical trial protocol that include these changes must be submitted. The applicant should also provide reasons for the changes made to the clinical trial protocol.

Firstly, applicants should strictly limit the use of relevant high-risk substances during the raw material selection and manufacturing process to ensure that any residues meet the safety requirements under expected usage conditions and to ensure batch-to-batch consistency, or conduct substitution studies for such high-risk substances. Secondly, a comprehensive risk assessment should be conducted on potential leachables that could be introduced into the final product at various stages, such as monomers, solvents, catalysts, cross-linking agents, and by-products that may arise during the preparation of raw materials, such as naphthalene, which can be a by-product in the production of divinylbenzene.

A vertebral plate fixation system, used in vertebral plating surgeries, is primarily composed of vertebral fixation plates and screws. Components that play a major functional role in the system and are made of different materials (such as the vertebral plates) should be divided into different registration units. Based on the commonly used metal materials for vertebral fixation plates, registration units can be divided into categories such as TA4 pure titanium, Ti6Al4V titanium alloy, etc. If the components of the product are made of different materials but are used together as a whole assembly or combination, they can be declared under the same registration unit.

In electromagnetic compatibility testing setups, there are distinctions between floor-standing and table-top equipment, with different requirements for test setups and potential differences in test results. Therefore, if a trolley is needed in actual use, EMC testing is usually conducted with the trolley as part of the floor-standing equipment setup; if a trolley is not needed, EMC testing is typically conducted as if for table-top equipment. If both conditions are applicable in actual use (i.e., the trolley is optional), then EMC testing should be carried out for both floor-standing and table-top equipment setups.

In vitro diagnostic reagents exempt from clinical trials do not need to start clinical evaluation after completing registration inspection. However, clinical evaluation can only be conducted after the product is fully finalized.

The mechanical performance indicators in the technical requirements for orthopedic medical devices are objectively determinable, meet the design inputs, and can confirm the product's functionality and safety through static mechanical indicators. The determination of these indicators ensures that the product meets the basic clinical needs. Applicants can refer to the mechanical performance test data of similar products already on the market and combine their own test data to make a comparison and derive specific requirements for the indicators.

The particulate contamination index method in YY/T 1556-2017 can be used, or the insoluble particles test method in the Chinese Pharmacopoeia can be adopted. When using the insoluble particles test method, it is recommended to add a requirement for the upper limit of particle size that should not appear, and the rationality of the upper limit requirement for particle size should be demonstrated. The technical requirements for the product must include specifications for particles.

The technical requirements for active medical device products generally do not need to specify transportation and storage conditions. It is only necessary to specify the normal working conditions. The transportation and storage conditions can be clearly stated in the instructions.

Disposable adhesive patches are passive consumables. According to the "Guidelines for the Division of Medical Device Registration Units," passive consumables that are used in conjunction or combination with active medical devices should, in principle, be classified as different registration units from those active medical devices.

Applicants should conduct biological evaluations in accordance with the requirements of GB/T 16886.1. For those requiring biological testing, the corresponding biological test reports should be submitted, and the biological tests should be carried out on the products being applied for. If submitting biological test reports for raw materials, it should be demonstrated that the processing steps from raw materials to finished products have not introduced new biological risks to the products. For relevant regulations on biological evaluation, please refer to the "Notice on Printing and Distributing Guidelines for Biological Evaluation and Review of Medical Devices"