NMPA: 247 Guideline Impacted By 2023 Revisions Plan

Republished By Plato

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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.

Guidelines 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 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
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