“Regulation on the Supervision and Administration of Medical Devices”, published in March 2021, mandates that “if the design, raw materials, production process, scope of application, method of use, etc. of registered Class II and Class III medical devices undergo substantial changes, which may affect the safety and effectiveness of the medical device, the registrant shall apply the registration modification to the original registration department”.
NMPA officials provide the following common issues of Class II active device modification to enable manufacturers better understand the requirements:
Changes in product model and specifications
Question: When the original models have not been changed but the new model is added which involves the new mandatory standards, do the registrant need to re-tests the original models against the new standard?
Answer: For newly added mandatory standards, only new models need to meet the requirements of the new mandatory standards and submit an testing report. In the product technical requirements, the content of the new mandatory standards should be noted that only the new models marked ** are added.
Questions: What to do when the key performance standards of the new product model are lower than those of original registration certificate?
Answer: The registrants shall provide evidence in the registration materials that the changes do not affect the safety and effectiveness of the product. Related materials include comparative evaluation of similar products, literature research, etc.
Question: Can registrant only submits the safety evaluation report of the original models, without conducting device testing on the new models?
Answer: Registrants should first confirm whether the new models and the original ones can be used as the same registration unit. If they can be used as the same registration unit, they can submit the modification registration. In the case that the new standard is not involved, the typical model should be identified. If the original model can represent the new model, there is no need to repeat the test; if the new standard is involved, the testing report of the new model against the new standard should be provided. If the test of some items in the test report of the original model can represent the test of the new model, there is no need to repeat the test for this part of the content.
Question: Does registrant need to submit the human assessment data required by the mandatory standards?
Answer: The composition materials, photoelectric components, structural forms, applicable people, fitting methods to the human body, use parts, specifications and performance indicators, etc. on the new model and the model should be analyzed and evaluated, and if there are differences, the human body assessment data should be supplemented.
Changes in product structure and composition
Question: Does the overall evaluation of the change need to be conducted if the electrical components, such as the housing structure and the overall sealing performance of the equipment, do not change?
Answer: The evaluation does not need to be conducted if the changes do not involve electrical safety standards or the electromagnetic compatibility standards; if the changed part involves electrical connections and affects the electrical safety standards/electromagnetic compatibility standard requirements, it needs to be re-evaluated, and the performance indicators involved in the changed part should be tested together.
Question: What to do if the key components of the product are changed, which only involve the supplier or manufacturer of the component, and the performance parameters have not changed?
Answer: If the key components of the product are changed, which only involve the supplier or manufacturer of the component, and the performance parameters have not changed, the registrant shall keep maintain quality management system requirements and ensure the continuous and effective operation. The testing does not have to be conducted.
Question: If accessories are added, the registrants can only test the safety performance without evaluating electromagnetic compatibility?
Answer: The electromagnetic compatibility testing is not required if the added components do not contain electronic components; if they contain electronic components, electromagnetic compatibility testing is required. For example, adding a wireless or wired foot switch that controls the operation, it should be tested for electromagnetic compatibility; if an ultrasonic probe piercing rack is added, and the accessory does not contain electronic components and is only physically connected, the electromagnetic compatibility testing is not required.
Question: Under which circumstances, the changes in software shall be applied for modification?
Answer: According to the “Guidelines for the Technical Review of Medical Device Software Registration”, major software updates (that is, a change in the software release version) of the software require a registration modification; If minor software updates occur, and the manufacturer controls the software based on robust quality management system, the modification is not required.
Changes in product scope and expected users
Question: The new functional parameters are added to the product, is clinical evaluation needed for the scope of application after the added parameters?
Answer: If the newly-added functional parameters are equivalent to the products in the clinical exemption catalog, they can be evaluated in accordance with the relevant requirements of clinical evaluation; if the newly-added functional parameter monitors have the same type of medical devices, they can be evaluated by clinical evaluation; if the monitors with newly added function parameters cannot be used for clinical evaluation in the above-mentioned manner, and clinical trials should be considered to confirm the scope of use of the product.
Changes in product technical requirements
Question: Can applicants directly convert the original product standards into Product Technical Requirements in the application materials?
Answer: The applicant should submit the product standard change. The registered product standard cannot be directly converted into product technical requirements through the modification application. The change approval document issued by the registration license is used in conjunction with the original certificate and the original product standard. The technical requirements of the product shall be issued after the approval of the renewal of the product registration.