Drugdu.com expert's response:

When enterprises apply for domestic registration of Class II active medical devices, they need to focus on demonstrating the product's safety, effectiveness and quality controllability. Compared with some passive medical devices, active products usually involve functions such as power supply, circuits, software, control systems and energy output. Therefore, in the registration review process, electrical safety, electromagnetic compatibility (EMC), software verification and product performance are the key areas of concern.

In accordance with the Regulations on Administration of Medical Device Registration and Filing of the National Medical Products Administration (NMPA) and Announcement No. 121 of 2021, domestic Class II medical devices are subject to registration review and approval by the provincial drug regulatory department where the enterprise is located, while imported Class II medical devices are reviewed and approved by the NMPA. The registration application materials shall be prepared in accordance with the specified catalogue and format, and the technical evidence shall be improved in combination with the applicable registration review guidelines for specific products.

First of all, it is necessary to confirm the product classification, registration unit and intended use. Enterprises need to clarify whether the product belongs to Class II medical devices according to the Medical Device Classification Catalogue and relevant classification rules, and determine the product name, structural composition, working principle, model specifications and scope of application. For active devices, special attention should be paid to the hardware configuration, software functions, control modes and performance differences between different models, so as to judge whether they can be divided into the same registration unit. If the product boundary is not determined, subsequent inconsistencies are likely to occur in the product technical requirements, selection of test samples and clinical evaluation.

Product technical requirements and test reports are important foundations for registration applications. Enterprises need to clarify the main performance indicators, safety requirements and test methods based on the product's working principle and intended use, and submit qualified product test reports. For active devices, items such as electrical safety, EMC, mechanical safety, temperature rise, alarm functions, output accuracy and environmental adaptability usually need to be evaluated, but specific items shall be determined according to product characteristics. For example, when applicable, safety standards for medical electrical equipment such as GB 9706.1, as well as corresponding collateral standards and particular standards, shall be considered. Enterprises should also check the current version and implementation requirements of the standards to ensure that the product technical requirements, test reports and actual product configurations are consistent. For registration testing, self-inspection reports that meet legal conditions can be adopted, or the testing can be completed by a qualified testing institution.

If the product contains software, corresponding software research materials shall also be provided. At present, many Class II active devices are equipped with functions such as data processing, parameter control, alarming, data transmission or remote management. For products containing software, enterprises need to explain the software functions, architecture, version, risk management, verification and validation in accordance with the applicable guidelines for the review of medical device software registration. If the product involves wireless communication, network connection, remote access or patient data transmission, cybersecurity research shall also be carried out in accordance with applicable requirements. Whether the software functions involve diagnostic or therapeutic decision-making will also affect the corresponding risk assessment and evidence requirements.

The clinical evaluation path also needs to be determined in advance. Not all Class II active medical devices are required to conduct clinical trials. Instead, enterprises shall judge which clinical evaluation method to adopt by checking whether the product is included in the catalogue of medical devices exempt from clinical evaluation, whether there are applicable predicate medical devices, and whether existing clinical evidence is sufficient. For products that carry out clinical evaluation through predicate device comparison, it is necessary to explain the differences between the product and the predicate device in terms of working principle, scope of application, key performance and usage methods, and provide corresponding evidence. When existing evidence is insufficient to prove the product's safety and effectiveness, clinical trials may be required.

In addition, the application materials shall also include product risk management documents, non-clinical research data, drafts of instructions for use and labels, manufacturing information, and quality management system documents related to product R&D and production. For active devices, risks such as electric shock, mechanical movement, overheating, abnormal output, misoperation, software failure and electromagnetic interference shall be focused on, with corresponding control measures and verification results specified. For devices for household use, with complex operation interfaces or high risk of use errors, usability engineering research shall also be carried out in accordance with applicable requirements. For products involving accessories, one-time contact components, sterilization components or special materials, research data such as biocompatibility, sterilization and shelf life may also need to be supplemented.

In terms of the quality management system, enterprises need to establish a system adapted to the product, covering design and development, procurement control, production management, inspection and release, equipment management, supplier management and traceability. During the registration process, the regulatory authority may carry out quality management system verification as needed, focusing on the authenticity of R&D, production and inspection processes, as well as the consistency between the application materials and actual production activities. In particular, enterprises involving entrusted production shall clarify the quality responsibilities between the registration applicant and the entrusted manufacturing enterprise in advance.

In actual applications, a common problem for active medical devices is the inconsistency among product technical requirements, test reports, software documents, risk management files and instructions for use. For example, the instructions claim that a certain function is available, but there is no corresponding evidence in the product technical requirements and verification data; after the software version is updated, the application materials are not adjusted synchronously; different models share the same test report, but the representativeness of the typical model is not fully explained. All these problems may affect the progress of technical review.

Therefore, for the preparation of registration materials for Class II active medical devices, it is recommended to conduct key inspections around several aspects: product classification and registration unit, product technical requirements, test reports, electrical safety and EMC, software and cybersecurity, risk management, clinical evaluation, and quality management system.

For enterprises, the most important thing before application is to ensure that the actual product design, test results, research data and registration documents are mutually consistent. All safety and effectiveness requirements shall have reasonable research, verification or evaluation basis, so as to avoid discovering missing documents or inconsistencies at the technical review stage.

In the specific application process, enterprises shall also check item by item in combination with the product classification code, applicable national standards and industry standards, relevant guidelines issued by the NMPA and the Center for Medical Device Evaluation (CMDE), as well as the application requirements of the local provincial drug regulatory department.