The NMPA issued the “Clinical Pathway Recommendations for Certain Active and Passive Implantable Devices” on April 6, 2022. The document suggests manufacturers how to choose predicate comparison or clinical trial for clinical evaluation. 25 classification names of active devices and 51 classification names of passive devices are affected.
The recommendations are based on the “Guideline on Decision Making of Conducting Clinical Trial for Medical Devices” published on September 2021.
Predicate Comparison List
NNMPA agrees that the devices under following classification names can go through predicate comparison pathway, instead of lengthy and costly clinical trial, 7 classification names of products are under active implantable devices 12 sub-category. 20 classification names of products are under passive implantable devices 13 sub-category:
Classification Code Classification Name
12-01-03 Temporary pacemaker
12-01-06 Temporary pacing leads
12-01-08 Implantable occlusion tool
12-01-10 Pacing system analysis equipment
12-01-12 Connector sleeve
12-02-04 Neuromodulation charging device
12-02-05 Implantable lead adapter tool
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13-01-02 Single/Multi-Part Absorbable Bone Fixation Devices
13-01-03 Single/Multi-Part memory alloy bone fixation device
13-03-02 Spinal interbody fixation/replacement system
13-03-03 Spinal pedicle system
13-03-04 Threaded fusion cage
13-03-06 Spinous process implants
13-04-01 hip prosthesis
13-04-02 knee prosthesis
13-04-03 shoulder prosthesis
13-04-04 Elbow prosthesis
13-05-01 Acrylic bone cement
13-05-03 Allogeneic bone repair material
13-06-01 Single/multi-part prefabricated cranioplasty plates and fasteners
13-06-02 Skull clip/lock
13-06-08 Intracranial coil system
13-06-09 Artificial skull
13-08-01 Ossicles prosthesis
13-08-02 Ear prosthesis
13-09-05 Patch fixer
13-11-02 Pectus excavation system
For our service page of Clinical Evaluation Report (CER), please click HERE
For our recorded webinar on “China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739”, please click HERE
Leading Companies
The clinical pathway recommendations involve a wide range of manufacturers. China Med Device, LLC suggest the following companies to be informed with the recommendations.
- Cardiac Rhythm Management
- Medtronic
- Boston Scientific
- Biotronik
- Philips Healthcare
- Defibtech
- Cardiac Science
- Styker
2. Neuromodulation
- Medtronic
- Boston Scientific
- Abbott
- LivaNova
- Synapse Biomedical
- Nevro Corporation
- NeuroSigima
3. Cochlear Implants
- Cochlear
- Advanced Bionics
- Med-El
4. Orthopedic Implants
- Stryker
- DePuy Synthes
- Zimmer Biomet
- Smith & Nephew
- Medtronic Spine
- NuVasive
- Wright Medical
5. Neurosurgery implants
- Stryker Corporation
- DePuy Synthes Companies
- Zimmer Biomet
- Medtronic
- Globus Medical Inc
- Brainlab
6. Cardiovascular implants
- Medtronic
- St. Jude Medical
- Boston Scientific
- Edwards Lifesciences
- Abbott Laboratories
- Johnson & Johnson
- Getinge
- Terumo
7. ENT Implants
- Ethicon
- Implantech
- Intersect
- Stryker
- Zimmer Biomet
8. Plastic implants
- ALLERGAN.
- Merz Pharma.
- Galderma laboratories
- Sinclair Pharma.
- BioPlus
- Bioxis pharmaceuticals
- SCULPT Luxury Dermal Fillers
- DR. Korman
9. Tissue Engineering Scaffolds
- Synthecon
- TransTissue Technologies
- CellServe
- Degradable Solutions
- Hybrid Organ
- hydromer