The NMPA announced the “2023 National Inspection Plan for Medical Devices” today (March 31, 2023). The Plan asks provincial NMPA offices and testing centers to conduct quality inspections based on Mandatory Standards and Product Technical Requirements (PTRs).
It has been three years without such massive plan due to COVID-19.
Full List of 2023 Inspection Plan Medical Devices
The plan covers 68 medical devices and IVDs. NMPA lists the inspection items for each product. Contact us at info@ChinaMedDevice.com if you have any devices as following in China market.
- ECG machine
- Mobile C-arm X-ray machine
- Patient monitor
- Endoscope
- Animal-derived patches
- ALDH2 gene test kit
- Septin9 gene methylation assay kit
- Treponema pallidum antibody test kit (immunochromatography)
- Hepatitis B virus core antibody detection kit (colloidal gold method)
- Cocaine test kit (colloidal gold method)
- Elastomer impression material
- Medical oxygen concentrator
- Cystatin C Assay Reagent (Kit)
- Hepatitis C virus (HCV) antibody test kit (colloidal gold method)
- C-reactive protein assay kit
- Homocysteine detection reagent
- Biofeedback therapy devices
- Weight loss gait training system
- Intense pulsed light therapy device
- Contrast injection device
- Infusion pump
- Electric suction
- Electric gastric lavage machine
- Non-absorbing polymer ligation clip
- Suction catheters for the respiratory tract
- Single-use biopsy needle
- Nd: YAG laser treatment machine
- Baby phototherapy equipment
- Slit-lamp microscope
- Soft contact lens
- Microcatheter
- Breathing lines for anesthesia machines and ventilator
- Human blood and blood components bag plastic container
- Ureteral stent
- Medical sodium hyaluronate gel
- Scar repair product
- Single-use sterile surgical membrane
- Far-infrared treatment patch, magnetic therapy patch, acupoint magnetic therapy patch
- Ultrasonic Doppler flow analyzer
- Ultrasonic bone densitometer
- Ultrasound therapy equipment
- Ophthalmic ultrasound diagnostic equipment
- Ophthalmic ultrasound surgical equipment
- Gynecological ultrasound diagnostic equipment
- Pressure steam sterilizer
- Dental low voltage electric motor
- Concentrates for hemodialysis
- Medical disposable protective clothing
- Medical surgical masks
- Medical protective masks
- Disposable medical masks
- Therapeutic ventilator (life support)
- Vascular stents
- Hip prosthesis – femoral stalk
- Hip prosthesis – femoral ball head
- Hip prosthesis – acetabular cup
- Hip prosthesis – acetabular lining
- Knee prosthesis – femoral condyle
- Knee prosthesis – tibial pad
- Knee prosthesis – tibial brace
- Spine plate
- Spinal rods
- Spinal screws
- Bone cement for the spine
- Intervertebral fusion device
- Intervertebral disc prosthesis
- Vertebroplasty balloon
The plan covers 68 medical devices and IVDs. The NMPA lists the inspection items for each product. Contact us at info@ChinaMedDevice.com if you have any devices as following in China market.
The Plan also lists institutions and procedures for inspection, retesting and appealing.
Mandatory Standards
Whether you are renewing or submitting new registration, your medical devices need to meet new mandatory 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.
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- Source: https://chinameddevice.com/2023-inspection-plan-medical-devices/
