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Eight Mandatory and Ninety Recommended Standards to be Revised in 2024: Revisions Plan Asks Your Feedback

NMPA issued the draft version of “2024 Medical Device Industry Standards Revisions Plan” on March 22, 2024, with the deadline for feedback on March 29. The plan proposes 8 mandatory and 90 recommended standards to be revised or established. The Standards Revisions are aimed to facilitate manufacturers with local type testing and regulatory submission and make standards more consistent with the international standards.

Work Scope

The plan includes manufacturing methods, performance testing standards, biological evaluation, non-clinical standards, and quality systems of the 86 medical devices and IVDs.

Legally Binding

Industry Mandatory Standardsare legally enforced. Decree 739 Regulation on Supervision and Management of Medical Devices, the highest law governing medical device industry in China, mandates that “medical device shall meet the national mandatory standards; if there are no national mandatory standards, they shall comply with the industry mandatory standards”.

The industry recommended standards are not legally binding but recommended by regulatory authorities.

For English version of the Decree 739 Regulation on Supervision and Management of Medical Devices, please email info@ChinaMedDevice.com.

The List

The plan lists 8 industry mandatory standards for the items as follow:

  • Respiratory equipment – Particular requirements for basic safety and essential performance of infant cardiopulmonary monitors (to be established)
  • YY 0502—2016 Joint replacement implant devices Knee prosthesis
  • YY 0118—2016 Joint replacement implant devices Hip prosthesis
  • YY 0055—2018 Dentistry Light Curing Machine
  • YY 0645—2018 Continuous blood purification equipment
  • YY 1290—2016 Disposable bilirubin plasma adsorbent
  • YY 1412—2016 Cardiopulmonary bypass system Extracorporeal cardiopulmonary support auxiliary equipment
  • YY 0731—2009 Downward discharge large pressure steam sterilizer

The plan also lists 90 recommended standards to be established or revised, including but are not limited to the following:

  • YY/T 1576—2017 Tissue engineering medical device products absorbable biomaterial implantation test
  • Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell chromosome aberration test (to be established)
  • Medical devices for human assisted reproductive technology Determination of sucrose, glucose, trehalose and fructose in assisted reproductive fluids (to be established)
  • Medical additive manufacturing metal powder reuse requirements (to be established)
  • Medical additive manufacturing polyetheretherketone powder for powder bed fusion (to be established)
  • Artificial intelligence medical device stroke CT image assisted analysis software algorithm performance testing method (to be established)
  • Artificial intelligence medical device cytopathology image assisted analysis software algorithm performance testing methods (to be established)
  • Summative usability testing methods for assisted surgical devices employing robotic technology (to be established)
  • Reliability verification method of auxiliary surgical equipment using robotic technology (to be established)
  • Interventional surgery control system using robotics (to be established)
  • Technical guideline for homologous recombination deficiency (HRD) detection based on hybridization capture sequencing (to be established)
  • Technical guideline for detection of circulating tumor DNA mutation (high-throughput sequencing method) (to be established)
  • Technical guideline for interpretation of somatic variations in tumors and sstablishment of databases (to be established)
  • Medical device real world data terms and definitions (to be established)
  • In vitro diagnostic reagent clinical trial biological sample management requirements (to be established)
  • YY/T 0887—2013 Radioactive seed implantation treatment planning system dose calculation requirements and test methods
  • YY/T 1540—2017 Medical Class II biological safety cabinet verification guide
  • N-acetyl-β-D-glucosaminidase assay kit (to be established)
  • Glycocholic acid determination kit (latex enhanced immunoturbidimetric method) (to be established)
  • Glucose-6-phosphate dehydrogenase assay kit (to be established)

For English version of the 2024 Standards Revisions Draft Plan, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

Huge Impact

Whether you are renewing or submitting new registration, your medical devices need to meet these new standards. Even if your renewals (every 5 years required by NMPA) have no changes, you still have to prove that your originally approved products can meet the new standards. As a result, your originally approved products will still need to go through local type testing to show that you are current with the new standards. China Med Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time.