The NMPA issued a notice on April 19, adding error correction matters into their electronic Regulated Product Submission (eRPS) system, effective on April 20, 2023.
They attached “folder structure of the electronic catalogue of declaration materials” as annexes:
- Administrative information
- Summary
- Non-clinical data
- Clinical evaluation data
- Product brochures and label samples
- Company’s Quality management system documentation
- Product’s Quality management system information
Since June 24, 2019, when the electronic filling system was in use, it has effected 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.
The Significance of the Electronic Regulated Product Submission (eRPS) System
- 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;
- More qualified documents required. Manufacturers and legal agents have to be prudent when submitting the electronic fills;
- 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;
- Internationalized requirements. A whole set of documents must be in line with Table of Contents (ToC), developed by International Medical Device Regulators Forum (IMDRF).
About China Med Device
China Med Device provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China.
Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, clinical standards, IVDs draft guidelines, eRPS, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.