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

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

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