Full List
The plan covers 76 medical devices and IVDs. NMPA lists the inspection items for each product. Email info@ChinaMedDevice.com if you have any devices as following in China market.
Anesthesiology
- Sleep apnea therapy device
- Electronic analgesic pump
- Therapeutic ventilator
- Medical pneumatic nebulizer
Cardiovascular
- Dynamic ECG recorder
- Embolic protection device
- Catheter sheath
- Disposable arterial compression hemostat
- Coronary vascular stent
- Peripheral vascular stent
- Drug-coated balloon dilatation catheter
Chemistry
- Potassium assay kit (enzymatic method)
- Total bilirubin assay kit
Dental
- Dental ceramic materials and products
- Dental implant
Ear, Nose, and Throat
- Audiometer
- Box-type hearing aid
- Cochlear implant
- Cochlear sound processor
Gastroenterology and Urology
- Peritoneal dialysis catheter
- Hemodialysis equipment
- Ureteral guidewire
- Ureteral access sheath
- Ureteral balloon dilatation catheter
- Nephrostomy kit
- Stone retrieval basket
- Single-use electronic endoscope
- Fiber ureterorenoscope
General and Plastic Surgery
- Hernia repair patch
- High-frequency surgical equipment
- Surgical electrode (high-frequency bipolar)
- Barbed surgical suture
- Nd:YAG laser therapy device
- Insufflator
- Medical sodium hyaluronate dressing
- Polyurethane foam dressing
General Hospital
- Hemostatic bandage for emergency use
- Medical protective mask
- Polyvinyl alcohol sponge
Hematology
- Anti-D blood grouping reagent (monoclonal antibody)
Immunology
- Hepatitis C virus (HCV) antibody test kit (colloidal gold method)
Microbiology
- Influenza A/B virus antigen test kit (immunochromatography)
Molecular Diagnostics
- EB virus nucleic acid test kit
Obstetrical and Gynecological
- Culture dish for assisted reproduction
- Follicle-stimulating hormone test kit (immunochromatography)
Ophthalmic
- Fundus camera
- Refractor (ophthalmic refractometer)
- Rigid gas permeable contact lens for orthokeratology
- Contact lens care product
- Intraocular lens
- Ophthalmic viscoelastic device
- Corneal surface viscoelastic protectant
Orthopedic
- Hip joint prosthesis – femoral stem
- Hip joint prosthesis – femoral head
- Hip joint prosthesis – acetabular cup
- Hip joint prosthesis – acetabular liner
- Knee joint prosthesis – femoral condyle
- Knee joint prosthesis – tibial insert
- Knee joint prosthesis – tibial tray
- Spinal plate
- Spinal rod
- Spinal screw
- Spinal bone cement
- Interbody fusion cage
- Intervertebral disc prosthesis
- Vertebral body balloon
- Sports injury soft tissue repair implant (including suture anchor, knotless anchor, fixation nail, fixation plate, repair suture, meniscus repair consumables)
- Artificial ligament
- Bone graft substitute (artificial bone, xenograft)
Physical Medicine
- Microwave therapy device
- Low and medium frequency therapy device
- Red light therapy device
- Joint training device
Radiology
- Mobile radiographic X-ray machine
- Vehicle-mounted X-ray machine
- Color ultrasound diagnostic system
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. info@ChinaMedDevice.com