Full List
The plan covers 66 medical devices and IVDs, including but are not limited to the following. NMPA lists the inspection items, referenced by mandatory standards, for each product. Email info@ChinaMedDevice.com if you have any devices as following in China market.
- Breast implants
- Assisted reproductive puncture and egg retrieval needle
- Electrocardiograph
- Medical pulse oximeter
- Helicobacter pylori antibody detection reagent
- Amphetamine detection reagent (colloidal gold method)
- CYP2C19 gene detection kit
- Powder/liquid acid-base cement
- Mycobacterium tuberculosis nucleic acid detection kit
- Intracranial coil
- Surgical electrodes (for high-frequency monopolar use)
- Medical molecular sieve oxygen concentrator
- Otoacoustic transmitter
- Soft Contact Lenses
- Rigid gas permeable contact lenses for orthokeratology
- Thrombus aspiration catheter
- Balloon inflation device
- Guide wire
- Titanium and titanium alloy dental implants
- Ophthalmic ultrasound diagnostic equipment
- Peritoneal dialysis equipment
- Intravascular stent
- Hip prosthesis
- Knee prosthesis
- Spine board
- Intervertebral fusion cage
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 on-site 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/2024-national-inspection-plan/
