Is it necessary to conduct on-site inspection for NMPA registration of medical devices in China?
分类:公司新闻 发布时间:2024-08-29 17:12:16
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!

Yes, on-site inspections are often necessary for NMPA registration of medical devices in China, particularly for Class II and Class III devices. The NMPA conducts these inspections to:

  1. Verify Compliance: Ensure that the manufacturing facility meets the required quality management standards, such as ISO 13485.
  2. Assess Production Processes: Evaluate the production processes and quality control measures in place.
  3. Confirm Device Safety and Efficacy: Verify that the device's design and manufacturing processes align with the submitted documentation and comply with safety and performance standards.

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!

Contact Us:

Whatsapp or Wechat:+86 15816864648;email address:hito.lin@grzan.cn

1(5).jpg