The National Medical Products Administration (NMPA) recently issued "Clinical Pathway Recommendations for Certain Categories of Medical Devices," aimed to simplify market access for surgical equipment in cardiac, neuro, ortho, medical aesthetic, and dental surgery etc.
These recommendations, based on the "Guideline on Decision Making of Conducting Clinical Trial for Medical Devices" from September 2021, impact 21 Class III medical devices. Manufacturers now have the option to choose predicate device comparison over clinical trials for clinical evaluation.
Predicate device comparison involves selecting approved device(s) of similar type based on the declared product's characteristics, clinical risks, existing clinical data, etc., to show the equivalency. These devices, including surgical navigation systems, breast biopsy systems, various prosthetics, and dental implants, among others, can now utilize CER (clinical evaluation report) pathway instead of the previous clinical trial pathway, now much faster and cheaper.
Manufacturers in cardiac, neuro, orthopedic, and medical aesthetic surgery fields are encouraged to review this to see if your products are impacted.
Feel free to reach out if you need an AI version of the products list.
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Grace Fu
China Med Device, LLC
gpalma@ChinaMedDevice.comPhone US: (978) 390-4453
Phone China: 18201749732
www.ChinaMedDevice.com------------------------------