Total 71 Frequently Asked Questions in 2023 Were Issued by CMDE

Here are 10 of 71 frequently asked questions:

  • 1. What key contents should be included in the structural design description of personalized abutment products?
  • 2. In the product instructions and technical requirements of quantitative detection of IVD reagents, what are the requirements for blank limit, detection limit and quantitation limit?
  • 3. How should the degradation performance of absorbable bone implant products be evaluated?
  • 4. What should we pay attention to when naming intravascular catheters and guidewire products suitable for a single blood vessel site?
  • 5. Image equipment accessory registration related issues – Series II: How to formulate relevant product technical requirements for passive accessories that are registered together with the equipment?
  • 6. What should be considered in the biological evaluation of blood purification products for patients with renal failure?
  • 7. In clinical trials of hepatitis C virus ribonucleic acid assay reagents, what should be considered when identifying the representative models?
  • 8. Is the pad thickness of conventional ultra-high molecular weight polyethylene noncompartmental knee prostheses required to be at least 6 mm (about 0.24 in)?
  • 9. Can Agent A of hemodialysis concentrate be packaged separately by ingredients?
  • 10. How does a disposable endoscopic injection needle perform in conjunction with an endoscope?

If you have any specific questions, we can help you to check the list and   interpretate the answers from the CMDE.