Yes, there is a time limit for the extension application of NMPA registration for medical devices in China. Typically, the extension application must be submitted at least 6 months before the expiration date of the current registration certificate. This timeframe allows the NMPA sufficient time to review the extension application and make a decision before the current certificate expires.

It's crucial to adhere to this timeline to avoid any lapses in your registration status, which could impact your ability to legally market your medical device in China. Additionally, extensions are typically granted for a specified period, often aligning with the original registration validity period, but this can vary based on regulatory changes and device-specific circumstances.

Always consult with your local agent or regulatory affairs specialist in China to ensure you meet all deadlines and requirements for the extension application process.