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Q&A – Product Specific Medical Device/IVD/CDx By Indication

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Frequently Asked Product Specific Questions (FAQ) about specific products’ questions and answers, sorted by the medical device:

How to conduct clinical trial for Soft Contact Lens?

NMPA published “Clinical Trial Guideline on Soft Contact Lens” on July 5, 2018. Key points:

– Applicable to soft contact lenses with optical imaging principle and correcting ametropia (excluding soft contact lens for astigmatism with cylindrical design)

– At least two clinical sites are required.

– Comparison device should be already approved in China.

– Efficiency endpoint: corrected vision for both eyes are no less than 5.0 after 1 week of trial.

– The total number of subjects should be no less than 120. In experimental group, the number of subjects should be no less than 60.

– Follow-up time is no less than 3 months.

Are there any clinical trial exemptions for Class III IVD?

Yes. NPMA published the “Clinical Exemption Catalog for Medical Devices” on September 30, 2018. The Category includes 31 Class III IVDs, all of which are cancer biomarkers:

1. Alpha-Fetoprotein (AFP) test assay
2. Carcinoembryonic Antigen (CEA) test assay
3. Total Prostate Specific Antigen (tPSA) test assay
4. Free Prostate Specific Antige (fPSA) test assay
5. Complexed Prostate Specific Antige (cPSA) test assay
6. Cytokeratin 19 Fragment (CYFRA21-1) test assay
7. Squamous Cell Carcinoma (SCC) test assay
8. Neuron-specific Enolase (NSE) test assay
9. Human epididymis protein 4 (HE4) test assay
10. Cancer Antigen 125 (CA125) test assay
11. Cancer Antigen 15-3 (CA15-3) test assay
12. Carbohydrate Antigen 19-9 (CA19-9) test assay
13. Carbohydrate Antigen 242 (CA242) test assay
14. Carbohydrate Antigen 50 (CA50) test assay
15. Cancer Antigen 72-4 (CA72-4) test assay
16. Throttle Position Sensor (TPS) test assay
17. Beta-2 microglobulin (β2 MG) test assay
18. Ferritin test assay
19. S100 Proteins test assay
20. Human Chorionic Gonadotropin (HCG) test assay
21. β-subunit of HCG gonadotropin (β-HCG) test assay
22. ProstaticPapanicolaou (PAP) test assay
23. Prostatic acid phosphatase (PACP) test assay
24. Progastrin-releasing peptide (proGRP) test assay
25. Pepsinogen I (PG I) test assay
26. Pepsinogen I (PGII) test assay
27. κ Light Chain test assay
28. λ Light Chain test assay
29. α-L-Fucosidase (AFU) test assay
30. Prolactin (PRL) test assay
31. Calcitonin test assay

product specific questions about china medical devices