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These Devices Are Recommended to Go Predicate Comparison: Faster Market Access for Cardiac Rhythm Management, Orthopedic and Neurosurgery Companies

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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

——————————————————————————————–

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.

  1. 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

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