Category: Guideline

The NMPA issued “Guideline on Product Classification of Brain-Computer Interface (BCI) Medical Devices” and “Guideline on Nomenclature of BCI Medical Devices” on June 30, 2026. These documents apply exclusively to

NMPA published the “2026 Medical Device Guidelines Revisions Plan” on April 27, 2026, affecting 56 Class III and 219 Class II devices. The revisions are aimed to facilitate manufacturers with

NMPA published 5 medical devices final guidelines on April 9, 2026. They are aimed to facilitate manufacturers with clarity in type testing, non-clinical and clinical evaluation and regulatory submission. The

NMPA published a draft document “Implementation Guideline for the Self-Testing Requirements of Medical Device Registration” on June 26, 2025 for feedback. Feedbacks need to be submitted by July 11, 2025.

NMPA published 12 medical devices guidelines on August 12, 2024. They are aimed to facilitate manufacturers with clarity in registration process. Significance of Device Guidelines The guidelines are prepared by

NMPA published 48 medical devices guidelines on May 27, 2024. They are aimed to facilitate manufacturers with clarity in registration process. Significance of Device Guidelines The guidelines are prepared by

NMPA published the “2024 Medical Device Guidelines Revisions Plan” today on April 11, 2024, in which 49 guidelines for Class III and 60 for Class II devices are affected. The

NMPA published the “Medical Devices Usability Engineering Guideline” on March 19, 2024. Below is the “Interpretation on Device Usability Engineering Guideline” issued on March 27, 2024. For the first batch

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

From April 1, 2024, some cosmetic devices shall not be produced, imported, or sold without obtaining a medical device registration certificate, which include radiofrequency (RF) equipment. For the list of

NMPA issued the “Clinical Evaluation Guideline with Predicate Comparison of Radiofrequency Ablation (RFA) and Microwave Ablation (MWA) Equipment (Draft)” for feedback on February 18, 2024. Feedback needs to be submitted

NMPA published the “Draft Guideline on Clinical Trial of Peripheral Drug-Coated Balloon Catheters” on February 5, 2024 for feedback. Feedback needs to be submitted by February 26, 2024. This guideline