China NMPA Released: Common Q&A For Medical Device Registrations In 2023
2024-02-08
China NMPA has recently unveiled a comprehensive set of 71 Q&A addressing common issues encountered in the medical device registration process. The questions cover various aspects of the registration process, offering valuable insights and guidance. We translate the title of the question. please contact us via info@bradyknowsmedical.com if you need to know the specifics .
No.
Title
1
What key elements should be included in the structural design description of personalized base products?
2
What requirements exist for the blank limit, detection limit, and quantitative limit in the instructions and technical specifications of in vitro diagnostic reagents for quantitative detection?
3
How should the degradability of absorbable bone implant products be evaluated?
4
When naming vascular catheters and guide wires for a single vascular site, what considerations are important?
5
Regarding accessories used in conjunction with imaging equipment, what are the relevant requirements for the technical specifications of passive accessories submitted together with the equipment?
6
How should the biological evaluation of blood purification products for patients with renal dysfunction be considered?
7
In clinical trials of hepatitis C virus ribonucleic acid detection reagents, how should coverage for different genotypes be considered?
8
Is a minimum thickness of 6mm required for the pad of conventional ultra-high molecular weight polyethylene knee joint prostheses?
9
Can component A of blood dialysis concentrate be separately packaged by ingredient?
10
How should the compatibility performance of disposable endoscopic injection needles be conducted with endoscopes?
11
In cases where infusion tubing and high-pressure contrast tubing have similar structural composition and materials, can they be included in the same registration unit?
12
How should the registration number/filing number/catalog number for “items needed but not provided” under the “Main Components” section of the instructions for in vitro diagnostic reagents be filled in?
13
Can the accelerated aging test in YY/T 0772.3 for conventional ultra-high molecular weight polyethylene material orthopedic implants be used interchangeably with the accelerated aging test in product stability studies?
14
How should the biocompatibility evaluation of disposable abdominal puncture instruments be conducted?
15
In changes to the registration of in vitro diagnostic reagents that include new applicable instrument models, should clinical evaluation data be submitted if the reagent or sample volume changes on the new models?
16
How should the bonding effectiveness of dental adhesives be evaluated?
17
How should the disinfection effectiveness and compatibility of citric acid disinfectant be studied for blood dialysis equipment?
18
For interventional devices applicable to coronary arteries, how should vascular models for in vitro simulation be selected?
19
How should the desensitizing effect of dental desensitizers be evaluated?
20
What considerations should be taken into account when conducting precision studies for qualitative in vitro diagnostic reagents based on immunochromatography?
21
In in vitro simulated usage studies for interventional devices for neurovascular applications, how should vascular models be selected?
22
What performance indicators are typically specified in the technical requirements for metal bone plate products?
23
How should the evaluation method for bacterial retention performance of the exhaust pores of medicinal liquid filters in YY 0286.1-2019 be selected?
24
When adding new applicable instruments to the registration of in vitro diagnostic reagents, what content should be emphasized in the description of product changes?
25
What performance indicators are typically specified in the technical requirements for hip joint prostheses?
26
What performance indicators are typically specified in the technical requirements for knee joint prostheses?
27
How should the security level of software and network security for IVD devices be considered?
28
In what form should data be provided for the spectral transmittance, elasticity, shear viscosity, and complex viscosity coordinates involved in the study of adhesive properties?
29
How should in vitro diagnostic reagents with different reference ranges be clinically evaluated?
30
When conducting clinical trials jointly for reagents and supporting instruments, can the same set of clinical trial data be used for separate registration applications? What issues should be noted?
31
Can the main unit and ablation needle of microwave ablation equipment be applied for registration separately? Should the cooperative use be limited?
32
What aspects of production technology should be considered for laser selective melting metal powder products?
33
What performance indicators are typically specified in the technical requirements for posterior spine fixation system products?
34
What types are included in endoscopic power equipment? How should the main performance indicators of each type of product be determined?
35
How should the extraction solvent be selected in the extraction performance study of contact lens products?
36
If the structure of a registered product includes a main unit and accessories (consumables), and the main unit is discontinued, can an application be made to change the registration to delete the main unit, retaining only the accessories to meet the current needs of compatible use?
37
If joint prosthesis products have hydroxyapatite/metal composite coatings, what research data should be submitted?
38
How should the performance of air filters in disposable infusion sets be evaluated for preventing microbial entry?
39
How should the evaluation of heat generation due to product material interaction be generally conducted?
40
How should the biological evaluation items for platelet plasma preparation devices be considered?
41
In the extraction performance study of contact lens products, how should test samples be selected?
42
When communicating with the Device Review Center, how should questions be expressed to further improve communication efficiency?
43
Is fading trial research required for all contact lenses?
44
How should design validation data be submitted for disposable sterile clamps?
45
How should the clinical trial design be considered for the registration of single-port laparoscopic surgical systems for gynecological surgery?
46
For tumor gene mutation detection companion diagnostic reagents based on high-throughput sequencing technology (NGS), which genes and sites can be included in the detection range?
47
Explanation regarding the extension of the registration deadline after the notification of innovative examination results is canceled
48
How should the study data on the dose-response relationship and energy safety be submitted for energy therapy devices?
49
If the raw materials for orthopedic and oral implant products come from two suppliers, what validations are required?
50
For absorbable synthetic high molecular weight polymer materials with a long degradation period used in bone implants or oral products, how should the degradation observation endpoint be set?
51
How should the term “continuous working time” be understood in the performance indicators of active medical devices?
52
What items need to be tested for citric acid disinfectant shelf life verification?
53
Can characteristics such as “portable” and “handheld” be added to the product name of medical electrical equipment?
54
How should batches and models be considered in the detection limit and linearity study of in vitro diagnostic reagents?
55
Is it feasible to directly divide the performance indicators of metal bone plate products into bending strength and equivalent bending stiffness based on thickness intervals?
56
What is the procedure for modifying contraindications in the instructions for already marketed medical devices?
57
When designing precision tests for quantitative detection in vitro diagnostic reagents, should each influencing factor be individually assessed?
58
What information should be provided when applying for registration for ultrasound diagnostic equipment with remote maintenance and diagnosis functions (not involving remote control)?
59
For absorbable implants or oral products made of synthetic high molecular weight polymer materials with a long degradation period, how should the degradation observation endpoint be set?
60
How should the performance research data for active medical devices be submitted?
61
Does the clinical use of disposable arterial blood sample collectors need to consider the interference of additives on sample analysis results?
62
When conducting electromagnetic compatibility tests, if the accessories (consumables) have a limited service life and cannot meet the continuous test duration, can the same model of accessories be replaced to continue testing?
63
When conducting mechanical tests on metal bone plate products, must the worst-case scenario be selected through finite element analysis?
64
If the chemical raw materials of citric acid disinfectant for heating and disinfection of blood dialysis machine tubing cannot find the registration certificate for pharmaceutical raw materials, can raw materials that meet the testing items under the Chinese Pharmacopoeia be used?
65
When there are changes in the performance indicators of in vitro diagnostic reagents, how should the registrant submit a change declaration?
66
How should the conformity requirements for national standards be described in the technical requirements for product registration?
67
For blood dialyzers compared to existing registered products, if only the shell material is different and other raw materials and processes such as dialysis membrane and adhesive are the same, can this model be added through a change in registration?
68
How should the performance research data for active medical devices be submitted?
69
Is a biological evaluation required for the catheter holder of neurovascular and cardiovascular intervention catheter products?
70
How should the instrument parameter configuration be described in the instructions for reagents?
71
Common problems in the design of clinical trials for medical devices—single-group target value design
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