NMPA (CFDA) issued the “Notice on Implementation of Electronic Submission System for Medical Device Registration” and “Technical Guideline on Registration Material Requirements for Electronic Submission System” on May 31. The electronic Regulated Product Submission (eRPS) will come into effective on June 24, 2019.
The eRPS 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.
After May 7, 2019:
Manufacturers and legal agent can apply for Certificate Authority (CA), a digital key, to access the eRPS System;
June 24, 2019:
The eRPS system is to be launched (http://erps.cmde.org.cn). Manufacturers and legal agent can do E-filling of registration materials without submitting paperwork. Method of paper submission is still reserved.
Before October 31, 2019:
Registration material shall be submitted in line with current regulation.
Start from November 1, 2019:
Registration material shall be submitted according to the “Technical Guideline on Registration Material Requirements for Electronic Submission System”.
For the English version of “Technical Guideline on Registration Material Requirements for Electronic Submission System”, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
1. More efficient and effective. For example, in terms of supplements, NMPA officers used to email manufacturers asking additional documents. With the E-filing system in place, manufacturers automatically receive the notice from NMPA;
2. More qualified documents required. Manufacturers and legal agents have to be prudent when submitting the electronic fills;
3. Strengthened post-market surveillance. If the adverse events or defects occur in post-market, the NMPA officers can easily go back to the records as the system establishes a reference in pre-market submission;
4. Internationalized requirements. A whole set of documents must be in line with Table of Contents (ToC), developed by International Medical Device Regulators Forum (IMDRF).
ChinaMed Device, as an NMPA certified legal agent, can help you produce the E-filling format and documents that meet the NMPA requirement.
For info on Chinese Device Label and IFU effective January 1, 2019, please click HERE.
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.