GB9706 has been released for a while, many friends who are engaged in medical devices may still be a little confused, today I will talk to you about the new version of GB9706 in an easy-to-understand way.
What are the improvements of the new version of GB9706 compared to the old version?
The new version of GB 97061-2020 and legacy GB 9706Compared to 1-2007, there are several major changes: First, a new concept - Basic Performance (EP) has been introduced, so that safety is no longer the only criterion. Second, integrate the content of risk management to make the equipment more safe and reliable. In addition, different protective measures are put forward for different groups of people, so that everyone can use it with peace of mind. In addition, fire protection requirements have become more stringent, making the equipment more durable. The requirements for protection against mechanical hazards have also been refined to make the equipment more robust and durable. At the same time, the usability requirements for medical electrical equipment are clarified, making it easy for everyone to use. Finally, specific requirements are put forward for programmable medical electrical systems or subsystems to make the equipment more intelligent.
What are the specific requirements for a programmable medical electrical system or subsystem?
Programmable medical electrical system (PEMS) refers to a medical electrical device or medical electrical system that contains one or more programmable electronic subsystems (PESS). A programmable electronic subsystem is a system based on one or more processing units, including software and interfaces, so "programmable" is equivalent to containing software. According to GB 97061-2020 3There are 90 definitions, and the definition of PEMS contains three concepts: PES, ME equipment, and ME system.
PEMS is part of PESS and is a system consisting of one or more processing units, including their software and interfaces. at GB 9706In 1-2020, for devices or systems that include PESS there are the following requirements: First, PESS must provide functions necessary for basic security or basic performance. This means that PESS cannot just be an additional function or feature, but a core part of a device or system. Secondly, PESS must comply with GB 97061-2020. This includes, but is not limited to: input validation, output validation, internal state validation, security validation, etc. Third, PESS must be able to withstand the environmental influences it may encounter and maintain its performance and safety. Fourth, PESS must have appropriate fault detection and fault protection measures in place to ensure that no harm is caused to patients or operators in the event of a failure. Finally, PESS software must be validated to ensure that it meets all functional and performance requirements. In short, GB 9706The requirements for PESS in 1-2020 are designed to ensure the safety and performance of medical electrical equipment to protect the safety of patients and operators. Therefore, you must pay attention to it when using medical electrical equipment!
The new standards have strict requirements for the basic safety and basic performance of ME equipment and ME systems. For example, all ME equipment and ME systems must comply with mandatory standards as well as technical requirements for registered or documented products. In addition, the new standard includes a parallel standard for the safety of medical electrical equipment: safety requirements for medical electrical systems, and a parallel standard for the safety of medical electrical equipment: programmable medical electrical systems. In practice, the part of the ME device or ME system that comes into contact with the patient is considered the application part, which is also a part that requires special attention and management. Therefore, for medical device registrants and record-keepers, it is not only necessary to ensure that the relevant products they produce meet the requirements of these standards, but also to encourage them to implement the new standards in advance to improve the overall improvement of the quality and safety level of active medical devices in China.
What is the impact of the new version of 9706 on the registration of medical devices?
In order to ensure the high-quality development of the medical device industry and the safety of public devices, the State Food and Drug Administration issued Circular No. 14 in 2023. This circular puts forward clear requirements from four aspects: strict implementation of relevant standard requirements, registration and filing related standard implementation requirements, inspection of relevant standard implementation requirements, and strengthening the supervision and management of standard implementation.
What does this mean?First of all, all medical devices wishing to be sold in the Chinese market must comply with the new national standard GB 9706Requirements for 1-2020. For those products that were registered before the implementation of the new GB 9706 series standards, the implementation method for the renewal of registration is also clearly specified. Provincial drug regulatory departments are also required to attach great importance to the implementation of the new version of the GB 9706 series of standards, and fully recognize the important supporting role of medical device inspection in the registration and supervision and management of medical devices.
Overall, the implementation of the new GB 9706 series of standards aims to further improve the safety and effectiveness of medical devices, ensuring the interests of patients and public health. So, if you're a manufacturer or seller of medical devices, don't forget to comply with these new regulations
How to deal with the new version 9706 when the medical device product registration certificate is changed
According to Article 39 of the Measures for the Supervision and Administration of Medical Device Production, after the implementation of the new mandatory standards, the registrant and filing person of medical devices need to identify the differences between the technical requirements of the product and the mandatory standards in a timely manner. If you need to change the registration or record, you have to follow the registration procedure.
Especially for active medical device products, we must meet the requirements of the new version of the GB9706 series standard after May 1, 2023. In order to ensure that the product can meet the requirements of the new standard, the company must complete the testing of the new version of GB9706 at least before May 1, 23, and then complete the change registration as soon as possible.
In addition, if a new mandatory standard for medical devices is issued and implemented during the validity period of the medical device registration certificate, the changes made by the registered product to comply with the new mandatory standards shall be subject to change registration. In this case, the registrant shall submit a copy of the change registration (filing) document and its attachments that have been approved by the original examination and approval authority before applying for renewal of registration.
In short, for the change of the registration certificate of medical device products, we should pay close attention to the update of relevant regulations and standards to ensure that the product always meets the latest mandatory requirements, and complete the corresponding change registration procedures according to the regulations. In this way, our products can remain competitive in the market
What is the impact of 9706 on products that have obtained medical device registration certificates?
For those products that have already obtained the medical device registration certificate, if the new GB 9706 series standard is released, it will be a good show!First of all, if the product needs to change itself according to the new standard, then the registrant must submit an application to make a copy of the change registration documents and attachments approved by the original approval department. If the product does not need to change at all, or if it does not need to be changed to meet the new standard, then the registrant will have to provide a statement of the facts and relevant supporting information.
Secondly, medical device registrants are encouraged to implement the new version of the GB 9706 series of standards in advanceThis not only improves product quality, but also allows everyone to enjoy the benefits of the new standards earlier.
Finally, medical device registrants and record-keepers can carefully implement the relevant regulatory requirements to ensure that the products they produce not only meet the mandatory standards, but also meet the technical requirements of the registered or filed products. After all, this is a major event related to everyone's health and safety!
Overall, the GB 9706 series of standards is implemented to make our medical devices safer and more reliable. For products that have already been registered, some adjustments may be required to meet the requirements of the new standard. However, as long as everyone does it in accordance with the new standards, I believe that the quality of our medical devices will definitely go to the next level!