If you work for regulatory submission with China NMPA (CFDA), you may have noticed the upcoming E-filling. Below is some information that I thought might be useful. I'd love to know your thoughts.
NMPA issued "Notice on the Application of Certificate Authority (CA) certificate for Medical Device Registration Service Platform (eRPS)" on May 7, which introduced the Certificate Authority (CA) to all the registrants. CA certificate is a digital certificate for NMPA's new electrical registration platform. This certificate should be applied for and held by manufacturers' legal agent in China.
To clarify this new regulation, manufacturers have to be current with the concept of "legal agent" in China. On August 3, 2018, NMPA (CFDA) published Guideline for Imported Medical Device Legal Agent (Draft) for feedback, which added more responsibilities to legal agents. Now legal agent's duties are not limited to product registration, they cover all the product lifecycle:
- Responsibility in regulatory submission via E-filling system
- Necessary communication with NMPA
- Handle Adverse Events and Recalls
- Prepare annual report
- Coordinate supply of maintenance and service manual,
- Help manufacturer prepare and handle the NMPA overseas inspection
What do you think about CA, E-filing and legal agent in China? I'd love to hear your perspectives. For any questions or comments please give a message here or email me at gpalma@ChinaMedDevice.com.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------