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2025 China NMPA Bluebook is here:
We are pleased to announce Grace Fu Palma, CEO of China Med Device, LLC, was selected to chair the opening panel of China Regulatory and Reimbursement Environment during The MedTech Conference
Monthly NMPA (CFDA) News Roundup (August) 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
Monthly CFDA News Roundup (August) Monthly 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
Biological testing points 1. Preparation of testing materials Technical requirements, specifications are equivalent to performance testing. The contracts may be different, it needs to be cleared in advance. 2. Identify
China’s guideline requires that the Class III medical device registration must submit a test report, and the test report should be issued by a certified medical device testing center. The
NMPA (CFDA), part of SAMR (State Administration of Market Regulation), issued Decree No.1 for Medical Device Adverse Event Reporting and Reevaluation on August 31st. More control, strictness and timely post-market
From 2009 to the present, a total of 138 products have been applied for classification, and nearly one-third of the products were applied in 2017 and 2018. The market for
CFDA announced “2018 Medical Device Industry Standard Revision Plan” on August 7th to make device regulations more consistent and stringent with international standards. It is the finalized version of the
CFDA announced Unique Device Identification (UDI) draft plan for feedback on August 22, to adequately identify medical devices through their distribution and use. When fully implemented, the label of all
On August 6, CFDA published 17 industry standards, covering sterilization of infusion device, biological testing, and standardization of medical consumables. 1. Test methods for packaging of sterilized medical devices: Breathable
In conjunction with the problems audited by the CNDA for clinical trials of medical devices, China Med Device, LLC summarizes some common problems and put forward some suggestions. Clinical
3 NMPA (CFDA) national leaders and 7 provincial leaders have been demoted as a result of the recent vaccines poor quality incident for the oversight over the substandard vaccines manufactured