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            Summary of common problems of active medical device registration

            Newstime: 2020-06-16 16:33:19

            1. A component in the product structure of a medical device belongs to a non-medical device. Can the component be reflected in the structure of the product registration certificate? Does the component need to be tested?


            Answer: For product components that are not managed as medical devices, they cannot be declared and registered separately, but can be used as an integral part of medical devices. If the part is declared as a component of a medical device, it should be evaluated as a part of the whole, and the part should be tested and verified along with the whole machine. If the applicant does not declare the part, or fails to test and verify the part with the whole machine, it cannot be approved as a product component.

            For example: printers, cables, endoscope lighting cables, neutral electrode cables, etc., all belong to this situation.

            Question: If it is not used as a part or registered, can a hospital be provided?


            2. Product change registration adds specifications and models (the original A and B models have not changed, new C and D models have been added), and it also involves the release or revision of new mandatory standards. Does the original model need to be implemented according to the new standard? Detection? Do product technical requirements need to add new standards?

            Answer: The change of permit matters adds new models. For the newly added mandatory standards, only the test report certifying that C and D meet the new mandatory standards needs to be submitted, and the content of the new mandatory standards is not added to the product technical requirements. The registrant shall ensure that A and B can also meet the requirements of the new standard from the date of implementation of the new mandatory standard. If the content of the new mandatory standard is added to the product technical requirements, a test report certifying that A and B also meet the requirements of the new mandatory standard should also be submitted. You can modify the technical requirements of the product when you renew the registration, add the content of the new version of the mandatory standard, and submit a test report that proves that A and B also meet the requirements of the new mandatory standard.


            3. Can the high-frequency electrode with coating on the electrode tip be divided into the same registration unit as the one without coating?

            Answer: According to the "Guiding Principles for the Division of Medical Device Registration Units" (General Administration Circular No. 187 of 2017), and referring to the "Guidelines for the Technical Review of Surgical Electrode Registration Technology" (2017 Revision), the electrode head end band The coated high-frequency electrode can be the same registration unit as the uncoated one.


            4. Each individual module in the active medical device combination product is a product in the "Catalogue of Medical Devices Exempted from Clinical Trials" (hereinafter referred to as the "Catalog"), so whether the combination product can also be regarded as a "Catalog" product?

            Answer: If the applicant can prove that the combination of the two does not affect each other, and the clinical use does not exceed the scope of the exempt catalog, it can be considered as a simple combination of the two exempt products. The modules are evaluated separately, and the applicant must evaluate the risks that the module combination may bring. If similar products are already on the market at home and abroad, the applicant should state the registrant, product name and quantity of the similar products that have been listed, and compare the similarities and differences between the proposed product and similar products in terms of technical methods, product performance and clinical application. The clinical use situation at home and abroad.


            5. Does the wirelessly connected active medical device accessories need to be tested by EMC? Does a purely physically connected active medical device accessory require EMC testing?

            Answer: Whether the EMC testing of active medical device accessories is irrelevant to the connection form of the product, mainly depends on whether the accessories affect the electromagnetic compatibility of the product. For example, for the wireless foot switch that controls the operation of the device, EMC testing is generally required. The pure physical connection and Ultrasound probe puncture racks that do not contain electronic components generally do not require EMC testing.

            6. When comparing products with the same product, if the software of the declared product and the comparison product are different, but they are used for the same clinical purpose, the difference between the two in actual use is not much. How to consider the impact of such differences during the technical review?

            Answer: During the comparison, the registration applicant should describe all the differences related to the software in detail, and analyze whether the differences affect the safety and effectiveness of the product. If necessary, the clinical/non-clinical data of the declared product itself should be submitted to prove that the difference has not adversely affected the safety and effectiveness.


            7. When conducting EMC testing for active products, do they need to be tested together with passive accessories in the product composition?

            Answer: Generally, all equipment and equipment used in EMC testing, cable layout and all accessories in the typical configuration should be the same as in normal use. If it is determined by analysis that the passive accessory has nothing to do with the EMC test, it is not necessary to test it together with the passive accessory. If a passive accessory must be used in order to achieve its basic performance during testing, the passive accessory should be used for testing. At the same time, full consideration should be given to the adverse conditions of the product during storage, transportation, and use, and corresponding stability studies should be conducted.


            8. Does medical optical endoscope and laser fiber need to be tested for electromagnetic compatibility?


            Answer: If the medical optical endoscope and laser optical fiber do not contain electronic components, but only optical components, then electromagnetic compatibility testing is not required. If there are electronic components (such as RFID identification devices, etc.) inside, electromagnetic compatibility testing is required.


            9. In the product technical requirements for active products, how should the "product model/specification and division description" be written?

            Answer: According to the "Guidelines for the Compilation of Technical Requirements for Medical Device Products", the product technical requirements should specify the product model and/or specifications, as well as the description of its division. For products with multiple models and/or specifications in the same registration unit, all differences between the models and specifications should be clarified (if necessary, a corresponding icon can be attached to explain). The larger text for the model/specification can be provided in the form of an appendix. For independent software or products containing software components, the name, model specifications, release version, and version naming rules of the software should also be clarified. The control software component should also specify the operating environment (including hardware configuration, software environment, and network conditions).


            10. Can the endoscope camera system and endoscope be used as the same registration unit?

            Answer: Whether it is a dedicated or general-purpose endoscope camera system, it should be divided into different registration units with the endoscope.


            11. Is it necessary to test if the active product applies for permission to change and add models? Can it be covered by the test report of the original model?

            Answer: First of all, you should confirm whether the added model and the original model can be used as the same registration unit. If they can be used as the same registration unit, you can apply for permission to change the additional model. In the case of not involving the new standard, the determination principle of the typical model should be followed. If the original model can represent the new model, there is no need to repeat the test; if the new standard is involved, the new model must be provided for the new standard. Report; if some items in the test report of the original model can represent the new model test, this part of the content does not need to be tested repeatedly.


            12. What is the core software algorithm? If there is no post-processing algorithm for medical imaging and data, can it be counted as a coreless algorithm?

            Answer: The core algorithm refers to the algorithms necessary to realize the core functions of the software (the functions necessary for the software to complete the intended use in the intended use environment), including but not limited to imaging algorithms, post-processing algorithms, and artificial intelligence algorithms.


            13. For clinical evaluation of active medical devices, is it necessary to compare the technical requirements of products approved by CFDA when comparing with the varieties? Is it feasible to compare only key parameters such as power and voltage?

            Answer: What needs to be compared is related to product characteristics. The performance indicators in the technical requirements are usually important indicators that describe the characteristics of the product, and usually need to be compared. Whether it is a key parameter depends on the specific product.


            14. What are the clinical locations to be considered in clinical trials of three types of X-ray products?

            Answer: You can refer to "Guidelines for the Technical Review of Medical X-ray Diagnostic Equipment (Category 3) Product Registration". The clinical site includes the chest, abdomen, bone, and soft tissue; if used for contrast imaging, the site should be increased in the gastrointestinal tract, aorta, organ organs, and coronary arteries (if any). Different clinical parts of the product are also different.


            15. What factors should be considered in determining the life span of active medical devices? What information should be submitted?

            Answer: 1. The use period of active medical devices can be determined by considering the following aspects: the service life of key components such as highly complete components, normal operation and single failure status during use, use frequency, use environment (corrosion, wear, Radiation, etc.), cleaning/disinfection/sterilization methods, component maintenance and repair, and previous empirical data. 2. The applicant should submit the basis for determining the expected service life of the product and a verification report. The verification report can provide the verification content of the service life of the system/equipment, or the verification content of the service life of key components, or empirical data. 3. Relevant responsible parties (manufacturers/users) should dynamically evaluate the service life of the product through risk analysis during the entire life cycle of the product. When the safety is reduced to an unacceptable level of risk, the use should be stopped.


            16. During the registration of active product licensing items, the electrical components do not change. Other changes, such as changes in the casing structure and changes in the overall sealing performance of the equipment, can be exempted from electrical safety and electromagnetic compatibility testing?

            Answer: The overall change of the declared product should be evaluated. If the changes in the shell structure, sealing performance and other electrical safety standards/electromagnetic compatibility standards require re-judgment or evaluation, a test should be conducted.


            17. When an active product such as a monitor is declared, the mainframe of company A and the consumables of company B are used together. Can the mainframe and consumables be declared in the name of company A?

            Answer: 1. If the consumable is applied to the human body in an invasive manner, it is recommended to register separately. 2. If the consumable of company B has obtained the registration certificate, and the consumable is a general accessory or the registration certificate indicates that it can be used with the host of company A, the consumable does not need to be declared together with the host of company A. 3. If the consumables of company B have not obtained the registration certificate, and the consumables do not act on the human body in an invasive manner, the host and consumables can be declared in the name of company A. Company A shall list all the consumable information used in conjunction with the host computer, such as brand, name, model, specifications, medical device registration certificate number (if any).


            18. Patient monitor products, add new functional parameters, do you need to conduct clinical trials when changing the registration?


            Answer: 1. If the newly added functional parameters are equivalent to the "Exempt from Clinical Trial Catalog" products, they can be evaluated according to the relevant requirements of clinical evaluation. 2. If the patient monitors of the newly added functional parameters have the same type of medical devices, they can be evaluated by clinical evaluation. If the overseas data of the newly added functional parameters comply with the "Technical Guidelines for Accepting Medical Device Overseas Clinical Trial Data", relevant clinical data can be provided. 3. If the patient monitor with newly added functional parameters cannot be evaluated clinically in the above manner, clinical trials should be considered to confirm the scope of product use.


            19. When the software changes, what kind of circumstances need to submit a registration application?

            Answer: According to the "Guidelines for the Technical Review of Medical Device Software Registration", major software updates (that is, changes in the software release version) are required to report changes in licensing matters; minor software updates occur, and the manufacturer controls through the quality management system. Registration changes, when the next registration (registration changes and renewal registration) to submit the corresponding application materials.


            20. Can the radiotherapy planning system and radiotherapy equipment be declared as the same registration unit?

            Answer: If the radiotherapy planning system is a general planning system and can be used with a variety of radiotherapy equipment, it should be declared separately; if it is a special planning system for a specific radiotherapy equipment, it can be declared together with the radiotherapy equipment.


            21. What problems should be paid attention to in EMC testing?

            Answer: 1. Relevance of inspection report

            The electromagnetic compatibility inspection report and the electrical safety inspection report shall be related to ensure the consistency of the inspected samples.

            2. Typicality of multiple models and accessories

            All products (including all models and all components) in the application unit shall be regarded as sample products. All the sampled products can be inspected as the inspected products, or the inspection engineer of the inspection center can analyze all the sampled products, and select the representative sampled products as the inspected products for inspection. The EMC inspection report should be clearly sent Inspection product information and inspection product information. The conclusion of the electromagnetic compatibility inspection report shall clarify whether the sample product conforms to the electromagnetic compatibility requirements and the standards.

            For some accessories included in the sample product, the inspection engineer of the inspection center analyzes and determines that it is not related to the electromagnetic compatibility inspection. The electromagnetic compatibility inspection report should clarify these accessories and the analysis conclusion. The inspection sample composition table does not need to reflect the information of these accessories.

            3. Determination of basic performance

            "Basic performance" refers to the performance necessary to achieve no unacceptable risk, considering whether its loss or reduction will lead to unacceptable risk.



            When determining the basic performance of a product, manufacturers should consider but are not limited to the following aspects: analysis of clinical safety risks, consideration of performance related to diagnosis/treatment/monitoring, various sensors, cables, application parts, control devices, display devices, Whether the performance of moving parts is affected by electromagnetic interference.



            The basic performance identified by the random file shall be used as the basic performance for the immunity test. If the basic performance is not identified in the random file, all functions should be considered as the basic performance for the immunity test.

            4. Selection of sample running mode

            The sample operation mode should identify the maximum emission operation mode. The sample operation mode shall comprehensively and in detail identify the “functions” described in the random document (see YY 0505-2012 Clause 2.212 for details), carry out the immunity test for each identified function, and perform the most adverse impact on the patient. Disturbance test.


            22. Under what circumstances should medical electrical equipment be subjected to environmental testing, and does it need to refer to the GB/T 14710-2009 standard?

            Answer: If the mandatory standards applicable to the products to be declared require the implementation of the GB/T 14710-2009 standard, the testing shall be conducted in accordance with the GB/T 14710-2009 standard and the relevant requirements of the mandatory standard.



            If the product to be declared is used in a special environment (such as high temperature, high humidity, or low temperature, etc.), supporting information that the product can be used in the corresponding environment should be provided in the research data.


            23. To which medical devices does the cybersecurity guidelines apply? Can network security documents be submitted in software description documents?

            A: The cyber security guidelines apply to the registration of medical device products of the second and third categories with network connection functions for electronic data exchange or remote control. The network includes wireless and wired networks, and electronic data exchange includes unidirectional, Two-way data transmission, remote control includes real-time and non-real-time control.


            At the same time, it is also applicable to the registration declaration of the second and third types of medical device products that use storage media for electronic data exchange. Storage media include but are not limited to optical disks, mobile hard disks and U disks.

            Network security documents should be submitted separately.

            Copyright ?2020 Jiangsu Tianli Medical Devices Co., Ltd.  ICP 20031867   Technical support: Yuanma technology

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