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September 7, 2018
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 […]
September 4, 2018
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 […]
September 4, 2018
NMPA (CFDA), part of SAMR (State Administration of Market Regulation), issued Decree No.1 for Medical Device Adverse Event Reporting on August 31st. More control, strictness and timely post-market surveillance will […]
September 3, 2018
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 […]
August 29, 2018
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 […]