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NMPA “Common Issues” Released in First Half of 2022

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The NMPA issued Q&A for 34 common issues aroused in medical device type testing and registration.

Full List of NMPA common issues

If you have similar questions for your device entering China, please contact us at this email info@ChinaMedDevice.com.

  1. Do medical device products (IVD reagents excluded) need to submit research data such as stability or packaging verification of different batches of products?
  2. How should the temperature for a real-time stability study of shelf life of passive medical devices be determined? What information should be submitted?
  3. Does the virus safety of animal-derived products have to be laboratory verified?
  4. Under what circumstances can an application for notification of modification of the specification be submitted for review?
  5. Do the material properties of medical device products need to be included in the technical requirements?
  6. Is it necessary to conduct in vivo metabolism studies for absorbable medical device products?
  7. Do the test reports in the research materials, such as dynamic tests such as fatigue, virological tests, and immunological tests, must be issued by a correspondingly qualified testing agency?
  8. What are the requirements for the medical device product inspection report submitted for registration or filing?
  9. Do I need to cite GB 9706.1 and YY 0505 standards when applying for registration of dental handpieces?
  10. How should the dental handpiece registration unit be divided?
  11. Can the added model of the high-voltage generator of the registered CT equipment be declared as the same registered unit?
  12. Imaging products for in-vehicle environments: Can the word “vehicle” be used in the product name?
  13. Imaging products used in in-vehicle environments: Can products used in in-vehicle environments be declared in the same registration unit as those used in hospitals?
  14. Imaging products used in the in-vehicle environment: can the vehicle be embodied in the product composition?
  15. Problems related to high-intensity focused ultrasound therapy equipment
  16. If the high-frequency ultrasonic integrated surgical equipment can output high-frequency or ultrasonic energy alone, but also output high-frequency and ultrasonic energy at the same time, how should the test mode be considered when conducting electromagnetic compatibility inspection?
  17. For the various measurement functions of the ophthalmic optical biometer, if the performance index has specified the measurement accuracy, is it necessary to consider the repeatability?
  18. When the laser therapy device is used for hair removal, a cold spray is used to reduce the temperature of the skin surface. What are the requirements for the cold spray function? Does the cold spray function need to be considered when performing performance, safety, and electromagnetic compatibility inspections?
  19. How are the registration units for facial injection filler materials divided?
  20. How to choose the worst-case sample for mechanical performance of interbody cage?
  21. What should be considered in the study of the fit performance of the personalized abutment?
  22. If the grades of the main raw materials of orthopedic products change, can the changes be made through the application for change of registration?
  23. How to determine the sample size for the dynamic test of the posterior spinal fixation system?
  24. How to understand the non-exemption of infusion products in the Exemption from Clinical Evaluation Catalogue?
  25. What are the requirements for raw materials for Vaseline gauze products?
  26. What needs to be stated in the “product performance index” of the in vitro diagnostic reagent instructions?
  27. The evaluation of analytical performance of in vitro diagnostic reagents requires the use of samples from different sources for research. How to understand “different sources”?
  28. What factors should be considered in the samples used for the stability study of in vitro diagnostic reagent samples?
  29. With the ELISA kit, can the reaction mode be changed from “two-step method” to “one-step method”?
  30. How to consider the type of clinical trial design of computer-aided decision-making products based on deep learning?
  31. Is it sufficient to provide in vitro burst pressure test and animal test as supporting evidence for the ultrasonic soft tissue cutting hemostatic surgical device that can close blood vessels up to 7mm?
  32. Do clinical trials need to test all models and specifications of the same registration unit?
  33. What should be paid attention to when using the reverse-type red blood cell reagent and the microcolumn gel card?
  34. Precautions for Bland-Altman analysis of quantitative test results of in vitro diagnostic reagents?

Again, if you have similar questions about any NMPA common issues for your device entering China, please contact us at this email info@ChinaMedDevice.com.