CMD Blogs

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

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

“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

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

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

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.

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

On March 21, 2019 the draft proposal of ” Medical Device Clinical Evaluation”, submitted by NMPA (CFDA) at the 13th International Medical Device Regulators Forum

NMPA (CFDA) approved the ‘human 10 gene mutation combined detection kit’, manufactured by Amoy Diagnostics, the first of its kind in the CDx (companion diagnostic)

NMPA (CFDA) issued the final version of “2019 Medical Device Industry Standards Revision Plan” yesterday (March 20), in which 93 medical devices, IVDs are affected.