TX Q&A

Radiation protection accessories used with X-ray radiation diagnostic devices, such as radiation-proof vests, caps, skirts, collars, and medical radiation protection glasses, are designed to protect the human body during radiographic procedures. These accessories usually have no power or other physical connections with the active equipment and are managed separately as medical devices in the classification catalog. It is recommended that they be declared separately, except for non-detachable accessories.

Article 5 of the "Guidelines on Acceptance of Medical Device Foreign Clinical Trial Data" clearly states, "If the technical review guidelines for a specific medical device include requirements for its clinical trials, the device's foreign clinical trials should consider these requirements. In case of inconsistency, sufficient and reasonable reasons and basis must be provided." Therefore, if the applicant has submitted clinical trial data that complies with ethical, legal, and scientific principles according to the "Guidelines on Acceptance of Medical Device Foreign Clinical Trial Data," and has adequately considered differences in technical review requirements, subject populations, and clinical trial conditions, it is not necessary to conduct additional clinical trials within China.

For the registration of in vitro diagnostic reagents, all documents issued by clinical trial institutions must be stamped by the clinical institutions. This includes, but is not limited to, clinical protocols and their attachments, clinical trial reports and their attachments. Special attention should be paid to ensure that items such as instructions, resumes, and sequencing data, which are attachments to the report, are submitted as part of the same document and have clear signatures, including over-the-seam stamps. The same requirements apply to supplementary clinical trial data. For example, if a clinical institution needs to provide additional explanations, supplement clinical data, or revise parts of the report based on feedback, these documents must also be stamped by the clinical institution for confirmation.

Firstly, it is recommended that the ultrasound scalpel heads, which can be used together with the main unit and transducer, be declared as part of the same registration unit. Secondly, although the declared registration of the product composition does not include Ultrasound Scalpel Head B, if the use of "Main Unit + Transducer + B Scalpel Head" together is applied for, it is necessary to prove the safety and effectiveness of their combined use. It is required to specify the performance indicators for combined use in the product technical requirements and submit an inspection report. Additional documentation related to combined use must also be submitted, including but not limited to dose-effect relationships, animal experiments, and clinical evaluation data. Since Scalpel Head B is not included in the product composition, there is no need to submit data related to unrelated physical properties (such as clamping force), chemical properties, biocompatibility, and packaging validity studies.

Spinal internal fixation screw-rod systems, used for spinal fixation, are primarily composed of connecting rods and screws. Products with different approaches should be divided into different registration units, such as anterior and posterior approaches. Products for different spinal segments should be divided into different registration units, such as cervical and thoracolumbar locations. If the component materials of the product are different but are used together as a whole assembly or combination, they can be declared under the same registration unit. If the material of the component that plays a major functional role in the system (such as the rod) is different, they should be divided into different registration units.

The risks vary for products depending on their animal source, manufacturing process, and intended use. For some common virus inactivation processes, such as organic matter, radiation, and strong acids, the procedures and methods are relatively mature, and there is ample reference literature available. It is not necessary to verify each one in a laboratory. Instead, consider using alternative approaches such as biological evaluation, immunogenicity assessment, and clinical evaluation, and rely on literature and historical data. Regarding the qualification issue, there are currently no specific regulations in medical device laws.

When there is a change in the packaging specifications of in vitro diagnostic reagents, it is necessary to provide a detailed description of the differences in packaging specifications before and after the change. Based on these differences, identify all relevant potential risks and analyze and verify these risk factors. For example, if there are differences in the form of reaction (such as drug detection products) or the size of the reaction strips (such as PCR amplification hybridization products) before and after the change, submit the analytical performance evaluation data for the new packaging specifications. Additionally, if there is a significant change in the amount of product and type of container, which could increase risks such as evaporation and loss, consider whether there are changes in the product's shelf life, stability during use, and calibration frequency.

Whether such products need to undergo clinical trials can be comprehensively determined by considering aspects such as the clinical functions of the product, its application scope, the adequacy of existing non-clinical validation, and the status of similar products already approved for market in the country. For example, the following two types of products can consider using a same-kind comparison pathway for clinical evaluation: 1. Patient preoperative image-guided percutaneous needle placement (including biopsy needles, ablation needles) in the thoracoabdominal area, generally including a needle-holding robotic arm, which can complete the needle placement according to the path confirmed by the doctor. 2. Tracking navigational surgical instruments, which guide the surgeon in performing surgical operations based on preoperative patient images, do not include a robotic arm, and generally involve preoperative planning of the surgical instrument's approach, and multimodal image registration/fusion functions. It is recommended to provide bench testing, animal testing, and clinical literature of similar products to demonstrate the safety and effectiveness of the product based on a thorough comparison and analysis of the clinical functions and performance parameters of the declared product with those of similar products. When necessary, consider providing cadaver experiment data that complies with relevant regulatory requirements.

Since the Bluetooth remote control function involves electronic data exchange, cybersecurity risks should be considered. Relevant documentation should be submitted in accordance with the "Guidelines for Technical Review of Medical Device Cybersecurity."

Spinal internal fixation plate systems, typically consisting of plates and screws, are used for spinal fixation. Products with different surgical approaches should be divided into different registration units, such as anterior and posterior approaches. Products for different spinal segments should be classified into different registration units, such as cervical and thoracolumbar regions. If the materials of the product components differ, but the products are used together as a whole assembly or combination, they can be registered under the same unit. If the materials of the main functional components in the system (e.g., plates) differ, they should be divided into different registration units.