Policies
21 Class III Devices Exempted for Clinical Trial: Faster Market Access for Surgical Equipment in Cardio, Neuro, Ortho, Aesthetic and Dental Applications
NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” 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.
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.
Visit HERE for the list of devices that can choose predicate comparison, instead of lengthy and costly clinical trial.
From April 1, RF Aesthetic Equipment Will Require Device Certificate
From April 1, 2024, some cosmetic devices shall not be produced, imported, or sold without obtaining a medical device registration certificate, which include RF equipment.
The radiofrequency (RF) aesthetic equipment, a Class III device, refers to products that use electrical energy such as radio frequency current (usually 200kHz or more) or electric field (usually 13.56 or 40.68MHz) to act on human tissues to produce thermal effects to treat skin sagging, reduce skin wrinkles, shrink pores, firm/lift skin tissue, or treat acne, scarring, or reduce fat (fat softening or breakdown). They include standing, desktop, and handheld devices.
For the “Registration Guideline for Radiofrequency Aesthetic Devices” issued in April, 2023, please click HERE
Guidelines & Standards
NMPA Usability Engineering Guideline Issued for Medical Devices
NMPA published the “Medical Devices Usability Engineering Guideline” on March 19, 2024. NMPA believes that, in improving the usability and the design of devices to minimize potential use errors and resulting harm, manufacturers will be able to assess and reduce risks associated with medical device use. This guideline is applicable for usability engineering design and related submission of Class III and Class II medical devices.
Visit HERE for our comprehensive analysis which includes the applicable devices list and the key points of the guideline.
Eight Mandatory and Ninety Recommended Standards to be Revised in 2024: Revisions Plan Asks Your Feedback
NMPA issued the draft version of “2024 Medical Device Industry Standards Revisions Plan” on March 22, 2024, with the deadline for feedback on March 29. The plan proposes 8 mandatory and 90 recommended standards to be revised or established.
The plan includes manufacturing methods, performance testing standards, biological evaluation, non-clinical standards, and quality systems of the 96 medical devices and IVDs.
For the full list of 2024 Standards Revisions Draft Plan, please click HERE
Fast-Track Approvals
NMPA Review Report Released for Intuitive Surgical’s Navigational Bronchoscopy System
The NMPA granted innovation approvals to Intuitive Surgical’s bronchial navigation system and issued a review report.
The system comprises four parts, navigation controller, optical fiber positioning catheter, visualization probe catheter and catheter guide. When used together, it employs shape-sensing fiber optic technology for bronchial navigation positioning.
Compared with similar products on the market, the outer diameter of the fiber optic positioning catheter of this system is smaller, which can enter deeper into the lung airways. The product is stable and precise, less susceptible to interference, and can effectively reduce the incidence of pneumothorax and bleeding complications, which is of great significance for improving patient survival rates.
For the product overview and preparation of pre-clinical and clinical data guided by the review report, please click HERE
PMS & QMS
2024 National Inspection Plan Released Today: Pay Attention to Your Device Standards
NMPA announced the “2024 National Inspection Plan for Medical Devices” on March 19, 2024. The Plan asks provincial NMPA offices and testing centers to conduct quality inspections based on Mandatory Standards and Product Technical Requirements (PTRs).
The plan covers 66 medical devices and IVDs, including but are not limited to the following. NMPA lists the inspection items, referenced by mandatory standards, for each product.
The Plan also lists institutions and procedures for inspection, retesting and appealing. Click HERE for the list of devices to be inspected.
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