On May 12, 2025, the National Medical Products Administration (NMPA) of China revised and announced the list of medical devices exempt from clinical evaluation to facilitate medical device registration and management.
The clinical evaluation exemption list was originally established in 2023 and updated in 2025. It announces categories of medical devices for which clinical evaluation can be waived if safety and effectiveness can be demonstrated through non-clinical data.
The revision of the clinical evaluation exemption list includes amendments to descriptions of certain existing items and the addition of 28 new items. The partial points are summarized as follows:
| No. | Classification Code | Item Name | Description | Class | Remarks |
| 94 | 02-15-00 | Personalized 3D Printed Surgical Model | Made from polymer materials such as photosensitive resin and polylactic acid(PLA). Designed based on patient medical imaging data after data conversion and 3D reconstruction, then printed as a physical model using a 3D printer. This model simulates the anatomical structure of bone lesions. | II | New |
| 159 | 03-13-06 | Delivery-type Intracranial Balloon Dilatation Catheter | Used to expend stenotic areas in intracranial arterial or venous vessels by balloon inflation, also provides a passageway for diagnostic or therapeutic devices | III | New |
| 184 | 03-13-28 | Atrial Septal Puncture Sheath | Used to insert various cardiovascular catheters into the left atrium via atrial septal puncture. | III | New |
| 252 | 05-04 | Radiation Therapy Support Equipment | All Class II products under the 05-04 subcategory are exempt from clinical evaluation. | II | New (items 251-255) |
| 320 | 06-14-01 | Ear Endoscope | A rigid optical endoscope generally composed of an optical imaging system and illumination system. Used to observe structures inside the ear. | II | New |
| 321 | 06-14-01 | Spinal Endoscope | A rigid optical endoscope generally composed of an optical imaging system and illumination system. Used to observe and image internal structures of the spine. | II | New |
| 356 | 07-03-03 | Non-invasive Dynamic Blood Pressure Recorder. | Uses oscillometric, Korotkoff sound, or similar non-invasive indirect blood pressure measurement principles to continuously measure blood pressure multiple times over an extended period. Automatically and dynamically measures patient blood pressure for diagnostic purposes. | II | New |
In addition, a total of 28 new items, including hyaluronic acid fillers (disposable sterile injection needles), biochemical immunoanalyzers, and urine analysis systems, have been added to the list of medical devices exempt from clinical evaluation.
These products are exempt from clinical evaluation if their safety and effectiveness are recognized as equivalent to those of already approved products. However, devices with new structural designs, new mechanisms of action, or drug-device combination products are excluded from this exemption.
Please refer to the attached document below.
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