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 life-ycle:
- 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 oversea inspection
ChinaMed Device, an NMPA (CFDA) certified legal agent in China, can certainly be your legal agent in China and help you manage all your China regulatory work. We have represented a lot of foreign companies and helped them manage their certificate in China. If you are interested in our legal agent services, we can provide you with our legal agent quotation. info@ChinaMedDevice.com.
For our comments on draft guideline of Legal Agent, please click HERE.
For Post-Market Surveillance Duties posed on Legal Agent, please click HERE.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.