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.
- When registering imported device, only the probative documents, declaration of conformity and labels shall contain the notarized documents issued by the notary body at the place where the applicant is located;
- Considering the folder structure of Regulated Product Submission Table of Contents (RPS ToC), the page number of the registration materials under the heading of any level can be compiled separately;
- The Technical Requirements in the electronic registration application materials should be contained in a single copy.
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.
China Med Device has helped clients submit E-documents for initial registrations and renewals. For inquiries on applying the Certificate Authority (CA), structuring of Table of Contents and formatting of Chinese / English E-documents, please email info@ChinaMedDevice.com.
For the timeline and impact on NMPA E-Submission, please click HERE.
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About ChinaMed Device, LLC
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.