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2026 China NMPA Bluebook is here:
CFDA issued medical device recall reports to 16 manufactures from Jan 28th to Feb 3rd. There are six foreign manufacturers on the list: •
China accelerates medical device innovation. In January 2018, four products got approved through fast track pathway in January. United Imaging: medical linear accelerator system Edwards
CFDA implements this 3-year plan to support central government’s effort to make medical device regulations more consistent with international standards. 300 standards for medical devices
CFDA policies, regulation updates, QA/recall/AE, and new approvals in medical device and IVD for the week of Jan 22-29, 2018: 1. Policy: CFDA announced
On December 29th 2017, CFDA issued Circular No. 226 of 2017, redefining the attributes and categories of IV diagnostic reagent products such as allergens, FACS,
CFDA is regulating mobile medical devices even closer. On 29 Dec, 2017, Guideline for Technical Review of Mobile Medical Device Registration issued by CFDA, specifying
OMD markets growing by 15% each year in China In China Orthopedic Medical Devices (OMD) are viewed as high value supplies with high technical content
Orthopedic medical devices among largest sub-sectors in the industry Orthopedic medical devices are one of the largest sub-sectors in the medical device industry. In addition
On January 8th, 2018, CFDA released a “Medical Device Clinical Trial Design Guidelines.” Here is a summary of the scope, purpose and coverage of this
The CFDA is putting greater emphasis on the quality system management and post-market compliance of overseas medical device manufacturers. In the past, very rarely did
After a major overhaul in 2014, the CFDA “Regulations on the Supervision and Administration of Medical Devices” have been focusing on registration quality management system
China Med Device publishes weekly CFDA updates covering medical device regulation, guideline, standard, recall, adverse event alert, recall, registration approval. Below are the CFDA updates