FAQ

First, manufacture should justify weather the update is considered as major update or minor update according to the Guidance fbr technical review of medical device software. It is also needed to justify whether the software version change is considered aspermission items, according to the naming rule and release version in the Product Technical Requirement.

If the update is considered as a major update with the change of release version, then Change of Permission Items is needed. If the update is considered as a minor update with the release version unchanged, administrative counterparts could manage it through the quality management system without submitting Change of Permission Items, but all the relevant research information of software should be provided during the next submission (Change of Permission Items or Registration Renewal).

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The software version is used to identify the software status and to control the software update. The naming rule of software version is decided during the software development process according to its own features, and used to identify the features of software development and update.

For medical device software, in addition to its own features and quality management system, regulatory requirements should also be considered, so as to reflect and identify different types of update and to determine the complete version and release version of the software.

The software version can be named in different ways according to the situation, and does not have to be named in the way of X.Y.Z.B. Manufacturers shall make clear all the segments of the software version and the meaning of each segment, and determine the complete version and the release version of the software.

If one segment of the software version could reflect either major or minor update, then according to the risk principle this segment should be considered as major update and be included in the release version.

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Software core algorithm refers to the algorithm necessary to realize the software core function (the function necessary for the software to complete the intended use in the intended environment), including but not limited to imaging algorithm, post-processing algorithm and artificial intelligence algorithm.

Even if there is no post-processing algorithm for medical images or data, if the device uses relevant software algorithms to achieve its intended clinical use (such as energy output control algorithm for therapeutic devices), it is also considered into the scope of core algorithms.

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The administrative counterparts shall submit an analysis and evaluation report on the service life of the product. The report shall specify the evaluation method, evaluation path, influencing factors and evaluation method, as well as the corresponding verification data. The verification data can be accelerated/real-time aging test data, empirical data, and other verification/validation data generated through reliability analysis method, simulation test method or other theoretical and simulation calculation methods.

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The manufacturer should dynamically evaluate the service life of the product through risk analysis in the whole life cycle of the product. When there is no unacceptable risk within the service life of the product after listing, the expected service life determined before listing can be maintained; or the expected service life determined before listing can be extended after reassessment; when the safety and effective performance of the product after listing is reduced to the extent that the risk is unacceptable within the service life, the relevant responsible party (manufacturer and/or user) shall assess this risk and take corresponding measures.

The following aspects should be considered in the determination of the service life of active medical devices: key components such as high integrity components, usage frequency and intensity, transportation and storage, usage environment, cleaning, disinfection, sterilization, component maintenance and commercial factors, etc.

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There are many cases of combination products in active medical devices. One product contains two independent functional modules, and each module belongs to a different classification category and code. In this case, the classification level should be managed according to the higher one of the two categories.

For the classification codes, if there is already clearly classified announcement, it shall prevail. If not, administrative counterparts may justify which module of the product is the major one and use the category and code of this module. If manufacture cannot justify, then either one can be used when submitting and no separate classification request is not needed.

For instance of the Integrated Surgical Equipment of Ultrasound and High Frequency, the category code of Ultrasound Surgical Equipment is 01-01-01 and the High Frequency Surgical Equipment is 01-03-01, both of which are class III device under 01 category, so the whole device is also class III. If the main function is the ultrasound surgical, then the application category code should be 01- 01-01.

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For instance, the registered models are A and B, and the new models are C and D. Then, for the new models, they shall be implemented with the requirements of the new standard, and the testing report and/or verification/validation data shall be provided.

If the original models A and B are not changed, then no relevant information is needed and new standard is not added into the Product Technical Requirements. Administrative counterparts shall ensure that A and B can also meet the requirements of the new standard from the date of implementation of the new standard.

If new standard is added into the Product Technical Requirements, testing reports and/or verification/validation data shall be submitted to certify A and B could meet the modified Product Technical Requirements.

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The contents contained in one registration certificate shall comply with the requirements of '"Guidance of registration units division for medical device". Whether it is able to add me to add models or accessories into the registration certificate of registered products depends on the difference between the new model and the originalmodel, as well as the relevance between the new accessories and the original products. If the newly added models or accessories and registered products can be divided into the same registration unit according to the guidance, they can be added via the Change of Permission Items.

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For the non-medical device components, they are not allowed to be submitted separately, but can be submitted as components of medical devices.

If this component is submitted as part of the medical device, it can be considered and evaluated as part of the whole device, and it should be inspected and verified together with the whole device. If administrative counterparts does not submit this component, or does not inspect or verify the component with the whole device, then it shall not be included in the product structure composition.

For example: Printers, Power supply cord, Fiber optic cables for endoscope, Connecting cables of neutral electrode, etc. They all belong to this situation.

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1. If the consumables of company B act on human body in an invasive way, it is recommended to register separately.
2. If the consumables of company B have obtained the registration certificate, and the consumables are general accessories or the registration certificate indicates that they can be used with the host of company A, it is not necessary to register the consumables 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 human body in an invasive way, the host and consumables can be registered in the name of company A.

Company A shall list all consumables information used together, such as brand, name, model, specification, medical device registration certificate number (if any) in the accompanying documents of the host.

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When imported medical devices is submitted registration in China, the scope of application of the medical device shall not exceed the scope when approved in the original country. If only part of the configuration is submitted, and the submitted part can be applied independently and the manufacture ensures its safety and effectiveness, manufactures can make reductions on the basis of the approved scope of original country.

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