Yes, the NMPA (National Medical Products Administration) registration process for medical devices in China typically requires on-site inspections, especially for higher-risk devices. Here are the key points regarding the on-site inspection requirement:

1. Risk Classification

• Medical devices are classified into three categories (Class I, II, and III) based on their risk level.
  • Class I devices are generally exempt from on-site inspections and require a simpler registration process.
  • Class II and III devices, which present greater risks, are more likely to require an on-site inspection as part of the registration process.

2. Purpose of On-Site Inspections

• The primary purpose of on-site inspections is to verify compliance with relevant standards and regulations. Inspectors assess various aspects of the manufacturing facility, including:
  • Quality management systems (QMS)
  • Good Manufacturing Practices (GMP)
  • Production processes
  • Documentation and records

3. Preparation for Inspections

• Manufacturers must be well-prepared for the on-site inspection. This includes having all required documentation organized and ensuring that facilities meet the necessary standards. Key preparations may include:
  • Training personnel on inspection procedures
  • Ensuring proper maintenance of equipment
  • Having quality control processes in place

4. Inspection Outcomes

• Following the inspection, the NMPA will review the findings. If the inspection is successful, the device may proceed toward registration approval. If issues are identified, manufacturers may be required to address them before registration can be granted.

5. Follow-Up Inspections

• In some cases, the NMPA may conduct follow-up inspections or audits to ensure ongoing compliance, particularly if there have been changes in manufacturing processes or significant modifications to the device.

In summary, on-site inspections are an integral part of the NMPA registration process for many medical devices, particularly those classified as higher risk. Manufacturers should prepare thoroughly to ensure compliance and facilitate a smooth inspection process.

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