In May 1st, the State Food and Drug Administration No. twenty-ninth - "medical device recall management measures" formally implemented, it will completely end the local mechanical enterprises even quality problems also uncommon recall state, instead of having to recall, otherwise it will be subject to regulatory sanctions.
Regulations clearly stipulates that the main domestic medical device registration relates to recall, as well as the domestic and foreign medical equipment designated agent. That is to say, we often only see the foreign enterprises product defects publicly recall, and CFDA will also announced on the official website of the phenomenon, will spread to all the domestic enterprises in the future, the recall has become a mandatory measures.
Since 2015, the drug regulatory system has gradually shifted the regulation of medical devices to the production, circulation, use of the entire process of double random inspection, as well as increasingly frequent sampling and routine inspection. Local medical device inspection does not meet the standard requirements of many products, in the CFDA flying level found, this year has released 9 "quality bulletin", and at the provincial level examination does not meet the standard requirements of more.
To be sure, with the flying check, sampling, routine inspection efforts to strengthen, China's 1.8 medical equipment manufacturers, the quality problems, quality defects will be exposed to the possibility of exposure will greatly increase.