|
- NMPA Medical Devices regulation - China Med Device
The NMPA issued the “Regulation on the Supervision and Administration of Medical Devices” on January 7, 2025, a revised version of the same-named
- NMPA (CFDA) Regulations - China Med Device
Resource Packages: "NMPA CFDA Regulations" - Check out China Med Device's take on various regulations available to you for downloading
- NMPA: Four IVD Guidelines Issued - China Med Device
NMPA published the four IVD-related guidelines on January 18, 2024 They facilitate manufacturers with more product-specific guidance
- Eighty-Five NMPA Standards to be Revised in 2025: By Indications
NMPA issued the “2025 Medical Device Industry Standards Revisions Plan” Six mandatory and seventy-nine recommended standards will be revised
- NMPA Roundup March 2025 - China Med Device
NMPA published the new draft “Medical Device Manufacturing Quality Management Standards” The proposed standards require enterprise digitalization systems to ensure regulatory compliance and data integrity It mandates risk-based validation for critical facilities, equipment, and processes
- Post-Market Surveillance for Medical Device Manufacturers - China Med . . .
NMPA Center for Medical Device Standardization Administration Issued the draft national standard “Post-Market Surveillance for Medical Device Manufacturers” on July 19, 2024, for feedback Feedback needs to be submitted by September 18
- AI Guidelines 2023 | China Medical Devices
The NMPA (National Medical Products Administration) affiliated Artificial Intelligence Medical Device Innovation Cooperation Platform has provided a comprehensive summary of six pivotal AI-related guidelines released in 2023 These guidelines, significant in their scope and detail, primarily focus on the unique aspects of AI medical devices
- China Medical Device Regulations – An Overview
China Medical Device Regulations – Medical Device Classification The NMPA classifies medical devices into three categories: Class I, Class II, and Class III Specifically, Class I – Medical devices for which routine administration can ensure safety for users and the effectiveness of the device Class II – Medical devices that can only be safe and effective with further control in
|
|
|