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NMPA on IVD Equipment and Hemodialyzer


NMPA published two Q&A on IVD equipment and hemodialyzer respectively, addressing two frequently asked issues:

Q: When applying for an in vitro diagnostic equipment registration change, is it necessary to conduct the cybersecurity registration inspection or third-party inspection?

A: According to the Guideline for the Technical Review of Medical Device Cybersecurity Registration, applicants should clarify the data interface and user access control requirements in the performance indicators of product technical requirements (PTRs). If the product approved before the issuance of the guideline does not reflect this indicator, and if the cybersecurity is involved, the cybersecurity performance indicator should be supplemented with the PTRs, and the supplementary item shall be subject registration inspection or third-party inspection by a qualified institution, and the cybersecurity

Q: How should the hemodialysis ultrafiltration rate (UFR) be designed for hemodialysis equipment?

A: According to YY 0053-2016 Hemodialysis Related Hemodialysis Filters, Blood Filters and Blood Concentrators, for the UFR test, the blood and dialysis fluid flow rate should cover the scope specified by the manufacturers. The test generally selects the lowest and highest point of dialysate flow rate, corresponding to the minimum flow rate specified by the manufacturers, and the blood flow rate of 100 ml/min per increase until the maximum blood flow rate specified by the manufacturers.

Please visit our Q&A page which concludes the common issues as following:

  1. Clinical Trials (Clinical Evaluation Report, Clinical Trial and Overseas Clinical Data)
  2. Registration (Initial Registration, Renewal, Modification, and Innovation Approval)
  3. QMS/PMS (Quality Management System, Post Market Surveillance, Overseas Inspection)
  4. Risk Evaluation
  5. Device specific questions

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