For Class I devices, the requirement for an on-site inspection may be less stringent, but it can still occur depending on the device type and risk level.If you're preparing for NMPA registration, ensuring your facility is audit-ready and adheres to relevant standards will help facilitate the process. If you have any more specific questions or need further guidance, just let me know!

NMPA certification requires adherence to a comprehensive set of standards and regulations, including GB standards, ISO standards, and specific device-related standards. The process involves meeting general and device-specific safety requirements, maintaining a quality management system, conducting necessary clinical evaluations, and complying with post-market surveillance obligations.If you have specific questions about any of these standards or need further details, let me know!

Preparing for NMPA certification involves assembling detailed documentation, designating a local agent, and submitting comprehensive application materials. Ensuring all documents are accurate and complete will help streamline the process and facilitate a smoother review.If you need more specifics on any part of this process, feel free to ask!

If you need more details or have specific concerns about preparing for an audit, feel free to ask!

The NMPA certification process for medical devices in China involves preparing detailed documentation, complying with specific technical standards, undergoing testing, and possibly conducting clinical trials. It's essential to work closely with a local agent or representative to navigate the regulatory landscape and ensure all requirements are met.

By adhering to these technical standards, manufacturers can ensure that their medical devices meet the necessary safety, efficacy, and quality requirements for NMPA certification in China.

These functions help ensure that medical devices are safe for use and that public health is protected.