NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” today on March 18, 2024. The document suggests manufacturers how to choose predicate device comparison or clinical trial to conduct clinical evaluation. 21 Class III medical devices in the fields of cardiac surgery, neurosurgery, orthopedic surgery, and dental and cosmetic surgery are impacted.

The clinical recommendations are based on the “Guideline on Decision Making of Conducting Clinical Trial for Medical Devices” published in September 2021.

The clinical recommendations for active and non-active devices are issued HERE.

Predicate Comparison List

Predicate device comparison means that, based on the declared product’s characteristics, clinical risks, existing clinical data, etc., select appropriate approved device of the same type, and prove the safety and effectiveness of the two devices by analyzing the clinical data.

NMPA agrees that the following devices can choose predicate comparison, instead of lengthy and costly clinical trial. The composition, the intended use, and device name examples are explained for each device:

• Surgical navigation system (with certain limitations)
• Breast rotational biopsy system and accessories
• surgical closure clip
• central venous catheter
• Shock wave therapy equipment
• Finger joint prosthesis
• wrist prosthesis
• Ankle prosthesis
• Acrylic resin bone cement
• Calcium salt bone filling implants
• Orthopedic metal fillings
• Hydrocephalus shunts and components
• Cardiovascular embolization devices
• Intravascular infusion implantable drug delivery device
• Gel dressing
• Collagen dressing
• Titanium Zirconium Dental Implants
• Dental bone filling and restorative materials

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 Surgery

• Medtronic
• St. Jude Medical
• Boston Scientific
• Edwards Lifesciences
• Abbott Laboratories
• Johnson & Johnson
• Getinge
• Terumo

Neurosurgery

• Stryker Corporation
• DePuy Synthes Companies
• Zimmer Biomet
• Medtronic
• Globus Medical Inc
• Brainlab

Orthopedic Surgery

• Stryker
• DePuy Synthes
• Zimmer Biomet
• Smith & Nephew
• Medtronic Spine
• NuVasive
• Wright Medical
• Globus Medical
• Össur
• Integra LifeSciences

Plastic Surgery

• ALLERGAN.
• Merz Pharma.
• Galderma laboratories
• Sinclair Pharma.
• BioPlus
• Bioxis pharmaceuticals
• SCULPT Luxury Dermal Fillers

• SEO Powered Content & PR Distribution. Get Amplified Today.
• PlatoData.Network Vertical Generative Ai. Empower Yourself. Access Here.
• PlatoAiStream. Web3 Intelligence. Knowledge Amplified. Access Here.
• PlatoESG. Carbon, CleanTech, Energy, Environment, Solar, Waste Management. Access Here.
• PlatoHealth. Biotech and Clinical Trials Intelligence. Access Here.
• Source: https://chinameddevice.com/clinical-pathway-recommendations-2/