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These Devices Exempted for Clinical Trial: Faster Market Access for Orthopedic Surgery, Blood Dialysis and Medical Software Companies

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The NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on July 14, 2022. The document suggests manufacturers how to choose clinical evaluation exemption, predicate device comparison or clinical trial. 139 medical devices in the fields of orthopedic surgery, dialysis, medical software, patient monitoring, anesthesia and physical therapy are affected.

The clinical recommendations are based on the “Guideline on Decision Making of Conducting Clinical Trial for Medical Devices” published in September 2021. Read our recommendations for active and non-active medical devices.

Clinical Evaluation Exemption List

The NMPA agrees that the following devices can choose clinical evaluation exemption pathway, instead of lengthy and costly clinical trial. The composition and the intended use are explained for each device:

Orthopedic Surgery

  • Patella claw
  • External fixation bracket
  • Splints and straps
  • Intraoperative traction frame and accessories
  • Orthopedic traction beds and accessories
  • Minimally invasive bone guide
  • Bone cement device
  • Fracture reducer
  • Bone cement setting mold
  • Arthroscopy kit
  • Vertebroplasty instruments
  • Discectomy instrument
  • Injection propulsion device

Dialysis

  • Blood component separation equipment
  • Blood cell processing equipment
  • Blood irradiation equipment
  • Plasma virus inactivation equipment
  • Blood melting device
  • Centrifugal blood component separator
  • Arteriovenous puncture
  • Blood transfusion set
  • Autologous blood treatment device
  • Plasma circuit
  • Frozen red blood cell washing machine
  • Platelet plasma preparer
  • Hemodialysis auxiliary equipment
  • Peritoneal dialysis aids
  • Blood purification aids

Medical Software

  • Radiation therapy planning system software
  • Radiation therapy assistant software
  • Surgery planning software
  • Medical image storage and Transmission System Software
  • Medical image processing software
  • Monitoring software
  • Physiological Signal Processing Software

Also listed are patient monitoring, anesthesia, and physical therapy devices.

See our service page on Clinical Evaluation Report (CER)

And watch our recorded webinar on “China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739

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.

Orthopedic Surgery

Dialysis

  • Becton Dickinson
  • Fresenius
  • Asahi Kasei
  • Baxter
  • Braun
  • MEDTRONIC
  • Nipro
  • Toray

Medical Software

  • McKesson
  • Cerner
  • Allscripts Healthcare Solutions
  • GE Healthcare
  • Computer Programs & Systems