Common questions and answers on the supplementation of technical review of Class II medical devices.
Question
The supplier of product peripherals (printers) has changed. Is it necessary to conduct a change registration for registered products?
Answer
It is necessary to evaluate whether the printer is a structural component. If it is, a change registration should be carried out. If not, it is necessary to evaluate whether the changes in the printer cause changes in the host interface, product internal circuit, and performance indicators. If involved, a change registration should be carried out.
Question
Can the medical central oxygen supply system only submit inspection reports for components such as manifolds and electric control cabinets that meet the requirements of GB9706.1-2020 and YY 9706.102-2021?
Answer
In accordance with the requirements of the “Guidelines for the Registration Review of Medical Central Oxygen Supply System”, the inspection report that meets the requirements of GB9706.1-2020, YY9706.102-2021, and YY 9706.108-2021 (if applicable) for the complete structural composition of the medical central oxygen supply system should be submitted.
Question
Should software components specify the operating environment in performance indicators?
Answer
According to the requirements of the “Guidelines for the Registration Review of Medical Device Software (2022 Revision)”, externally controlled software components and dedicated independent software regarded as software components should clearly define the operating environment in the performance indicators.
Question
For in vitro diagnostic instruments, when applying for registration change items to add models, can the test reports of the original model be used for coverage?
Answer
On the premise that the new model can be used as the same registration unit, enterprises should judge the typicality of the performance of the original model. If the performance indicators of the new model are different, the enterprise should conduct testing on the different parts. However, regarding the typicality of electromagnetic compatibility requirements, it should be explained by a medical device inspection institution or tested separately for the new model.
Question
What documents can be referred to for usability research materials?
Answer
- Standard: YY/T 1474—2016, YY/T 9706.106—2021
- Guiding principles: “Guiding Principles for the Registration Review of Medical Device Usability Engineering” released in March 2024.
- Registration data requirements shall refer in principle to “X. Application Instructions” in the “Interpretation of the ‘Guidelines for the Registration Review of Medical Device Usability Engineering’ issued by the Center for Medical Device Evaluation of the State Drug Administration.”
Question
In the process of supplementing the registration materials for in vitro diagnostic reagents, is it possible to add applicable models?
Answer
No. The applicable models for in vitro diagnostics should be determined based on the analytical performance research data and be completed before the registration application.
Question
What information should the nameplate of in vitro diagnostic instruments contain?
Answer
The nameplate of in vitro diagnostic instruments shall comply with the relevant requirements of the “Provisions on the Management of Medical Device Instructions and Labels” and GB4793.1, YY 0648, etc. Its contents include but are not limited to product information, manufacturer information, production date, service life, serial number, power connection conditions, warning signs, city and country and other contents.
Question
Is it necessary to apply for a change in registration when replacing the operating system software for an active medical device, such as changing from iOS to the HarmonyOS operating system?
Answer
If the operating system software for medical devices needs to be replaced, it belongs to a major software update and an application for change registration should be submitted.
