In August 2021, the CMDE published several interesting case studies to address some of the detailed requirements for IVDs and SiMDs to comply with regulatory requirements in China. A selection is extracted below.
Can the version number not be updated if the registrant considers that adding a clinical function to the SiMD (Software in Medical Device) product is a minor change?
No. A change in the clinical function is considered as a significant change to the software. Unless the manufacturer already indicated the type of change clearly in the version number of the SiMD, otherwise, it should be indicated before the product launch in China according to the following guidelines for nomenclature:
The standard format of the version number is X.Y.Z.
X represents a major update
Y represents a minor update
Z represents a correction
Can samples be repeatedly used when evaluating the performance of IVD test reagents?
No. In order to fully evaluate the different performances of IVD test reagents such as accuracy, precision, limit of detection, specificity, etc., tests should be carried out on multiple samples with but not limited to the following characteristics:
- Samples from different sources
- Different models of samples
- Samples with different concentration
Can IVDs be exempted from biological evaluation?
Biological evaluation cannot be exempted. However, if the product is manufactured from materials that meet the requirements listed on the Appendix B of YY 0341.1, the product’s equivalence with a predicate device will be a deciding factor to whether the biological testing will be exempted. For instance, if the manufacturing processes (sterilization, packaging, etc.) of the product and its predicate device are different, new hazardous substances (residues of sterilizing agents, processing aids, mold release agents, etc.) that appear indicates new biological risks. On other hand, biological testing can be exempted if there are no new biological risks for such cases.
Details to be paid attention for the clinical tests of IVDs
When the clinical tests of IVDs are carried out using certain samples as specified in the product IFU, the applicability of the following technical contents should be considered:
- Collection method of samples
- Storage conditions
- Storage time
- Handling of samples
Any claims in the IFU of the test reagents should be supported by preclinical studies and the requirements listed in the IFUs of both test reagents and review reagents should be compared and paid attention to. For instance, the following requirements should be paid attention to when carrying out clinical tests for nucleic acid detection reagents:
- Keep the samples stored within the valid period as specified in the IFU
- Use raw clinical sample data for clinical data whilst extracted DNA or RNA nucleic acids do not fall into this scope
- Adopt the use of nucleic acid extraction/purification reagents or sample preservation solution (if applicable) as specified in the IFUs of both test reagents and review reagents
- Meet the requirements on the level of purity and concentration of extracted nucleic acids as specified in the IFU
By Colleen Xu, Chelsey Shao, Nina Yan and Jacky Li. Contact Cisema if you would like to learn more.