Disposable electronic endoscopes, 3D endoscopes, and capsule endoscopes are not exempt from clinical trials
The endoscopes listed in the exemption from clinical trials catalog are limited to products with conventional designs. Disposable electronic endoscopes (including those designed for single use entirely, or combination endoscopes with only the insert part intended for single use), 3D endoscopes, and capsule endoscopes do not fall under the products exempt from clinical trials.
How to evaluate the detection of variant strains in the registration process for new coronavirus nucleic acid detection reagents
To meet the needs of epidemic prevention and control, companies should continuously monitor virus mutations and proactively evaluate the detection of new coronavirus variant strains for all nucleic acid detection reagents. The evaluation results should be submitted along with the registration materials (including product registration, change of registration, and renewal of registration). For products that have been issued but not yet updated, companies should also supplement this information. The evaluation should involve bioinformatics analysis based on the gene loci, primers, and probe designs used in the product, as well as the virus mutation patterns. If a variant strain is found that may affect product detection, further validation experiments should be conducted using real clinical variant strains containing the relevant mutation sequences or synthetically created samples. When using synthetic samples for validation experiments, dilution studies should be conducted for all applicable sample types of the product, covering at least the minimum detection limit and precision. For the methods of study, refer to the "Key Points for Technical Review of Registration of 2019 Novel Coronavirus Nucleic Acid Detection Reagents." If the evaluation indicates that the reagent may miss detecting variant strains, it is recommended to modify the product design and re-evaluate the product.
What to consider when submitting ethical documents and clinical trial protocols for in vitro diagnostic reagents
Clinical trial data for in vitro diagnostic reagents should include the clinical trial protocol to be implemented and the corresponding written opinion from the ethics committee consenting to the conduct of the clinical trial. Due to possible changes in the clinical trial protocol, multiple versions may exist, and the following principles should be noted when submitting application materials: If changes to the clinical trial protocol occur before the official start of the trial, the final version of the clinical trial protocol to be implemented should be submitted, along with the ethics committee's written opinion corresponding to that version. If the clinical trial has already started and changes to the protocol occur during the process, both the pre- and post-change versions of the clinical trial protocol and their ethical documents should be submitted together, with a clear explanation of the reasons for the changes and their impact on the ongoing clinical trial. It is important to thoroughly research the scientific validity, rationality, feasibility, and compliance of the protocol before the clinical trial, to develop and strictly implement the plan; changes to the protocol should not be made arbitrarily during the clinical trial unless necessary.
Can radiation protection accessories for X-ray radiation diagnostic devices be declared together with the diagnostic equipment?
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.
Notes on the Signature and Stamping of Initial and Supplementary Clinical Trial Data Submissions for In Vitro Diagnostic Reagents
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.
For ultrasound soft tissue cutting and hemostasis equipment, such as the main unit and transducer, which can be used with ultrasound scalpel heads not included in this registration unit, what are the requirements for the declaration materials?
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.
How should the product registration units for spinal internal fixation screw-rod systems be divided?
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.
What documentation is required for an application to change the packaging specifications of in vitro diagnostic reagents?
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.
For medical device products derived from animals, is it necessary to conduct virus inactivation validation in a qualified laboratory?
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.
Should surgical navigation systems that use optical and/or electromagnetic tracking technology for guiding percutaneous needle placement or tracking navigational surgical instruments necessarily provide clinical evaluation data based on clinical trials?
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.