Yes, medical devices generally need to undergo regular re-certification for continued registration in China. Here’s how it typically works:

**1. Registration Renewal:

• Frequency: Medical device registrations are usually valid for five years. Manufacturers must apply for renewal before the registration expires.
• Requirements: The renewal process involves submitting updated documentation, including any changes in product information, clinical data, and compliance with current regulations.

**2. Ongoing Compliance:

• Post-Market Surveillance: Continuous compliance with NMPA requirements is necessary. This includes monitoring product performance, reporting adverse events, and conducting regular quality management audits.
• GMP Inspections: Manufacturers may be subject to periodic inspections to ensure adherence to Good Manufacturing Practices (GMP).

**3. Product Changes:

• Notification: Significant changes to the product or its manufacturing process must be reported to the NMPA. Depending on the change, re-certification or additional approvals might be required.

**4. Regulatory Updates:

• Adaptation to New Standards: Manufacturers need to adapt to any new regulations or standards issued by the NMPA, which could affect their certification status.

Regular re-certification and compliance with post-market requirements are crucial for maintaining the validity of medical device registrations in China.