“Electronic Regulated Product Submission (eRPS) will come into force by the end of June, 2019”, Zhong Lu, deputy head of NMPA Center for Medical Device Evaluation (CMDE), announced at the NMPA eRPS Seminar. “By end of 2019, domestic Class III and all imported medical devices and IVDs will be required to go through this system.
Two parts, Electronic Submission and RPS Table of Contents, are included in the upcoming eRPS system, covering preparation, categorization, preview and submission of regulatory documents.
Aimed at reducing unnecessary regulatory burden for manufacturers, the eRPS will have major implications on registration, renewal, supplement and post-market surveillance. For example, NMPA officers used to email manufacturers asking additional documents. With the E-filing system in place, manufacturers automatically receive the notice from NMPA. It also establishes reference on pre-market submission if the adverse events or defects occur in post-market.
ChinaMed Device can help you produce the E-filling format that meets the new NMPA (CFDA) requirement. info@ChinaMedDevice.com.
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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.