The value of a certain performance indicator specified in the industry standard usually represents the minimum level required in the industry and is the minimum requirement that the product should meet. In the product design and development phase, the administrative counterpart cannot rely solely on national or industry standards. When formulating relevant indicators, the administrative counterpart should analyze the indicator requirements that the product should meet in order to satisfy the intended clinical use, so as to ensure the safety and effectiveness of the product. When determining the numerical requirements of the performance indicator in combination with the product’s own structural characteristics, the administrative counterpart should be able to provide the basis to ensure that the requirements of the performance indicator are reasonable and scientific.
Yes. It is required. The product IFU of the infusion set with DEHP-plasticized polyvinyl chloride (PVC) as the raw material for tubing should include the following:
Clearly identify that the product contains DEHP;
The warning information should clarify the following related information:① DEHP-related toxicity;②"This product is not suitable for storage and infusion of fat-soluble liquids and drugs such as fat emulsion”; (3) “Newborn, pre-pubertal men, pregnant and lactating women should not use this product for infusion of drugs.
The label of the blood bag should comply with the requirements of the “ Provisions for Instructions and Labels of Medical Devices”(CFDA Degree No. 6), and should in addition, at least indicate the following: the description of the content and intended use, nominal volume of whole blood and blood components collected, instructions for restriction conditions like sterile and pyrogen-free, instructions for not use if any macroscopically visible signs of deterioration are found, instructions indicating for single use only, batch numbers, intended storage period of whole blood or blood components, etc.
Yes. A urinary catheter is a medical device used for urine drainage and bladder irrigation, etc. Its material includes natural latex, rubber, silicone, or polyvinyl chloride (PVC). Petroleumbased lubricants such as liquid paraffin, petroleum jelly, etc., have a swelling effect on natural latex materials. After the balloon of the urinary catheter swelled, a thin-walled structure is formed. Under the effect of petroleum-based lubricants, the risk of rupture increases. Therefore, it is recommended to use water-soluble lubricants for balloon urinary catheters made of natural latex. Petroleum-based lubricants such as liquid paraffin and petroleum jelly should be avoided. Silicone urinary catheters should avoid the use of silicones as lubricants. Administrative counterpart should list relevant risk information in product IFU and labels.
Many kinds of visual acuity charts are used in clinical ophthalmology in China. At present, LogMAR visual acuity chart is recommended in clinical trials for non-active ophthalmic products, such as corneal contact lenses and intraocular lenses, while standard logarithmic visual acuity chart can be acceptable either.
The orthodontic bracket is generally made of metal, porcelain or polymer material, and is used to bear and transfer the orthopedic force of orthopedic wire in orthodontic treatment. It belongs to products listed in the “Catalogue of Medical Devices Exempted from Clinical Trials” (hereinafter referred to as the Catalogue), but the products which are made of new materials, with new technologies, new designs or have new mechanisms of action and new functions are excluded. In the process of clinical evaluation, it is necessary to submit the comparison data of the product related information with contents described in the Catalogue, a comparison description of this product and the predicate products which have been available in Chinese market as well as the corresponding supporting documents. If the above-mentioned documents can prove that this product is equivalent to products listed in the Catalogue, it is exempted from clinical trial; if not, it is necessary to perform clinical evaluation in accordance with the “Technical Guidance for Clinical Evaluation of Medical Devices".
Magnetic attachments are generally composed of female and male parts, and are divided into keyway type, bar type, snap type and ball-cap type according to the structural composition. If the product is indicated for the auxiliary retention of such restorations as removable partial denture and overlay denture, this product belongs to products listed in the “Catalogue of Medical Devices Exempted from Clinical Trials" (hereinafter referred to as the Catalogue), and clinical evaluation should be performed according to the clinical evaluation requirements for products listed in the Catalogue; if the product is used in combination with the implant to assist the retention of abutment and implant as well as the protection for implant prior to the placement of upper structure after implantation, this product should be considered as the upper restoration structure of implant and does not belong to products listed in the Catalogue. In this case, it is feasible to perform analysis and evaluation based on the data obtained in the clinical trial or clinical use of the predicate device or perform clinical evaluation through clinical trial.
In the case that the product under application includes both cervical intervertebral fusion cage and lumbar intervertebral fusion cage, if clinical trials are carried out, under the homogenous condition on cervical and thoracolumbar cases enrolled, that is, until the end of the follow-up time, the spinal internal fixation system in the diseased segment treated has not been removed, in order to ensure the comparability between the investigational group and the control group, the cervical and thoracolumbar indications can be combined for clinical trials. It is recommended that each group include cervical or thoracolumbar spine cases, which are not less than one third of the total number of cases in this group.
The predicate device refers to the product that has been approved for registration in China and are basically equivalent to the product under application in terms of basic principle, structural composition, manufacturing materials, manufacturing process, performance requirements, safety evaluation and intended use, etc. If the administrative counterpart can prove that differences between titanium alloy (Ti6A14V)-based abutment and pure titanium (TA4)- based abutment would not affect the safety and effectiveness of the product, such product can be used as the predicate device for comparison.
Based on whether it is covered by the "Catalogue of Medical Devices Exempted from Clinical Trials (Revised),, (hereinafter referred to as the Catalogue), polyurethane foam dressings can be subjected to clinical evaluation in the following two aspects:
For polyurethane foam dressings that meet the requirements of the Catalogue, the administrative counterpart should submit the comparison data of the product under application related information and the content described in the Catalogue, and a comparison description of the product under application and the medical devices that have been approved for registration in China in the Catalogue and the corresponding supporting documents.
For polyurethane foam dressings that are not within the scope of the Catalogue, on the premise of meeting the requirements of registration regulations, the clinical data of appropriate predicate products should be selected for clinical evaluation in accordance with the "'Technical Guidelines for Clinical Evaluation of Medical Devices" and a clinical evaluation report should be issued in accordance with the Guidelines. The administrative counterpart can also confirm the safety and effectiveness of the product in clinical application through clinical trials. If a clinical trial is conducted, consideration should be given to the purpos
Porcelain-fused-to-metal powder is a kind of porcelain material with matching performance melted and covered on the surface of metal crown to overcome the brittleness problem of pure porcelain material. Porcelain-fused-to-metal powder is usually divided into the following types: opaque porcelain; body porcelain (translucent porcelain, dentin porcelain); neck porcelain (gingival porcelain); and enamel porcelain. The differences among the above- mentioned different types of porcelain-fused-to-metal powder in terms of composition and content range shape different performance characteristics of different layers of porcelain. In the physical and chemical performance tests on such products, it is necessary to respectively select each type of porcelain powder. In the same type of porcelain powder, it is feasible to select the most commonly used color code and the darkest color code as the typical model.