2023 National Inspection Plan Released Today: Pay Attention to Your Device Standards

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.