NMPA (CFDA) issued “Notice on Requirements for Medical Device Electronic Submission” on July 10. It lists three requirements which are to be implemented on August 1, 2019.
The electronic Regulated Product Submission (eRPS) has taken into effect on June 24, 2019. The system affects domestic class III, imported class III and imported class II medical devices and IVDs. The scope includes initial registration, supplement, renewal, modification, type test request, high-risk Class III devices’ clinical trial request, modification of Instruction for Use (IFU), Innovation Approval application, etc.
For the timeline and impact on NMPA E-Submission, please click HERE.
To keep up to date on NMPA (CFDA) changes, please opt in our monthly newsletter https://ChinaMedDevice.com/cmd-blogs/
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.