Yes, NMPA (National Medical Products Administration) certification for medical devices in China typically involves regular re-certification or renewal.

Here are the key details about the process:

1. Certificate Validity Period

• Initial NMPA registration for most medical devices is valid for 5 years from the date of issuance.
• After this period, manufacturers need to apply for re-certification or renewal of their registration in order to continue marketing and selling the product in China.

2. Re-certification Process

• Application Submission: Manufacturers must submit a renewal application to the NMPA before the certificate expires. This is usually done within 6 months prior to the expiration date.
• Review: NMPA will review the device's safety and efficacy based on updated information, such as:
  • Post-market surveillance data
  • Changes in manufacturing processes or materials
  • Changes in product design or labeling
  • Updates to clinical trial data (if applicable)
• No Major Changes: If there are no major changes to the product, the process may be faster. However, if there are significant changes (e.g., new manufacturing facilities, major design modifications), a more extensive review may be required.

3. Post-Market Surveillance

• During the validity of the registration, manufacturers are also required to conduct post-market surveillance and report any adverse events or changes that could affect the safety or efficacy of the device.
• If any critical issues arise, NMPA may ask for additional information or even suspend the device’s registration before the end of the 5-year term.

4. Renewal Application Timeline

• It’s important to begin the renewal process 6 months before the expiration date to avoid any interruption in market access.
• The process involves submitting updated documentation, quality system audits, and possibly new clinical data, depending on the device classification.

5. Re-certification for Medical Device Classifications

• Class I Medical Devices (low-risk): Typically face fewer hurdles for re-certification and may not require extensive documentation or clinical data updates.
• Class II and III Medical Devices (medium to high-risk): These devices are subject to a more rigorous renewal process, which may include clinical trial data, additional performance testing, and regulatory updates.

6. NMPA Certification Maintenance

• Manufacturers must ensure that their Quality Management System (QMS) and compliance with relevant national standards are maintained. This is a key component of both initial certification and the renewal process.

In summary, while NMPA certification is not a one-time process, regular re-certification or renewal ensures that medical devices continue to meet the necessary safety, quality, and regulatory standards in China.