CFDA Updates

April 29, 2019

New Classification Procedures for Combination Device Take Effect on June 1, 2019

NMPA (CFDA) issued Notice on Classification Procedures for Combination Device on April 17th. The new procedures will be effective on June 1, 2019: A specialized department, NMPA Standardization Management Center […]
April 24, 2019

Do You Need Animal Study for Your Device? NMPA Gives 12 Devices as Examples

NMPA (CFDA) issued “Medical Device Animal Study Technical Review Guideline Part I: Decision Principles” on April 19. The guideline lists 12 devices as examples to discuss if animal study is […]
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), […]