CFDA Updates

April 19, 2019

NMPA: E-Filling to be Effective in Two Months

“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 […]
April 11, 2019

Huge Market for Ortho-K Lens in China

The International Congress of Ophthalmology and Optometry China (COOC) 2019 was held on March 22-24, 2019 in Shanghai, China. Myopia Management White Paper (2019) was released as well. COOC was […]
April 10, 2019

Monthly NMPA News Roundup (March 2019)

Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by ChinaMed Device, LLC (www.ChinaMedDevice.com), […]
April 8, 2019

Overseas Companies Qualify for Innovation Approval, while All Approved are Domestic

In January 2019 NMPA published Catalog of Innovation Approvals, in which 54 medical devices and IVDs are approved, and 197 medical products are under review. The 54 approved include 22 […]
April 5, 2019

The Implied Approval of Clinical Trial for Medical Device Takes Effect on April 1, 2019

NMPA published Notice of Modification on Medical Device Clinical Trial Approval Procedure on April 1. The Notice allows that, once the receipt of Clinical Trial Application is received, the sponsor […]