Policy

In addition to the previously effective policies, the new regulations issued by the National Medical Products Administration (NMPA) concerning high-end medical devices provide stronger support for innovation and development in the medical endoscopy industry. The key contents are as follows, according to the NMPA:

Optimize the approval and review processes: Implement an innovative special review procedure for innovative medical devices, including high-end endoscopes, and subject their registration changes to the same special review process. Accelerate the formulation and revision of technical review guidelines for products such as laparoscopic surgical systems, thereby establishing clear standards for the registration and submission of endoscope-related products.

Improve the standards and classification system: Promote the formulation and revision of fundamental and general standards in fields such as high-end medical imaging equipment; establish standardized technical organizations for AI-powered medical devices, among others. Conduct research on the regulatory classification of new-modal endoscopic products, and dynamically adjust these classifications based on the maturity of the technology to align with the pace of technological innovation in the industry.

Strengthening Communication and Regulatory Assurance: Enhance the pool of expert reviewers for high-end medical devices, shift the focus of review forward to earlier stages, and intensify pre-approval reviews during the R&D phase. Select innovative endoscopic products for regulatory consultations, refine technical review requirements for the registration of usage periods of high-end active medical devices, and at the same time, strengthen post-market monitoring of adverse events to ensure the clinical safety of these products.