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NMPA: 247 Guidelines Impacted by 2023 Revisions Plan

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The NMPA published the “2023 Medical Device Guidelines Revisions Plan” on April 4, 2023, in which 247 guidelines are affected. The revisions are aimed to facilitate manufacturers with local type testing and make guidelines more consistent with the international counterparts.

Significance of Device Guidelines

The guidelines are prepared by NMPA Center of Medical Device Evaluation (CMDE). They are not legally binding but are highly recommended by regulatory authorities.

For both renewals and new registrations, medical devices need to meet these new guidelines. Even if renewals (required every 5 years by NMPA) have no changes, manufacturers still have to prove that the originally approved products can meet the new guidelines.

As a result, approved products still need to go through local type testing to show that they are current with these new requirements. 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.

The NMPA Medical Device Guidelines Plan to be Established or Revised

The plan involves the guidelines for technical review for type testing, clinical trial and registration, and Indication for Use (IFU) writing. It impacts 63 newly established Class III, 66 newly established Class II and 118 revised Class II devices guidelines. For the complete list of guidelines please contact us by email info@ChinaMedDevice.com.

Class III Guidelines include:

  • Hemodialysis equipment
  • X-ray flat panel detection imaging system
  • Single-photon emission/X-ray computed tomography system
  • Positron emission/magnetic resonance imaging system
  • X-ray computed tomography equipment – spectroscopy technology
  • Laparoendoscopic surgical system – three-dimensional laparoscope
  • High-frequency surgical instruments for flexible endoscopes
  • Corneal topography mapper
  • Abdominal endoscopic surgical system
  • Intracranial spring ring
  • Peripheral vascular stents
  • Thrombectomy stents
  • Lamina fixation plate system
  • Single-use intravenous indwelling needles
  • Dialysate filter
  • Human MTHFR gene polymorphism detection reagent
  • Aldh2 gene polymorphism detection
  • HLA-B27 gene detection reagent
  • PD-L1 detection reagent
  • Gene methylation detection reagents for auxiliary diagnosis of colorectal cancer
  • Antibiotic susceptibility testing reagents
  • Drug-coated balloon dilation catheter
  • Thermal ablation treatment system
  • Embolic system of intracranial aneurysm
  • Medical linear accelerator
  • ECMO system
  • Medical magnetic resonance imaging system
  • Treat ventilators
  • Cardiac radiofrequency ablation devices
  • High-frequency surgical equipment
  • Ophthalmic phacoemulsification and anterior segment vitrectomy
  • Imaging ultrasound diagnostic equipment
  • Internal fixation system of the spine
  • Intervertebral fusion device
  • Dental implants
  • … …

Again, for the complete list of guidelines please kindly contact us by email at info@ChinaMedDevice.com.

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