CFDA Deputy Director Jia Hong: This year will severely punish medical device violations

From March 25 to 27, 2015, the Deputy Director General of the State Food and Drug Administration, Jia Hong, went to Anhui to investigate and supervise the supervision of medical devices, and held a symposium on the implementation of new regulations on medical devices. Vice Governor Hua Jianhui of Anhui Province accompanied the investigation.
In his research and supervision, Zhuo Hong pointed out that after the promulgation and implementation of the newly revised Regulations on the Supervision and Administration of Medical Devices, the food and drug regulatory departments in various places earnestly implemented and firmly promoted the registration and supervision of various medical devices, and improved the overall level of medical device quality and safety in China.
Jiao Hong stressed that the next step at all levels of food and drug regulatory departments should focus on the following five aspects of work:
First, to further strengthen the improvement of the regulatory system and the implementation of the regulations and regulations have been issued and the implementation of training, local authorities may not be unauthorized to decentralize the new Regulations provide for provincial and municipal regulatory departments to approve and record work matters, unauthorized decentralization must be resolutely corrected.
second is to divide administrative affairs power reasonably on a province-by-provincial level, and to construct a regulatory pattern that focuses on the provincial and municipal levels and complements the county level.
is to strengthen the capacity-building of the regulatory team, according to the development of the industry and regulatory needs of the jurisdiction, to enhance the technical support capacity and level of medical devices.
fourth is to continue to do a good job of medical devices "five rectification" special action to look back, increase supervision and inspection and exposure, severely punish violations of laws and regulations. The good experience and good practices gained in the supervision of medical device production and operation in various places should be carefully studied and promoted in a timely manner.
5th, we should carefully comb through the problems and suggestions found in the implementation of the new medical device regulations, formulate effective regulatory systems and working guidelines, and ensure that the new regulations and new policies are implemented.
In the course of investigation and supervision, Jia Hong went to Hefei Municipal Service Center and some medical device manufacturers to learn more about the medical device approval and filing procedures and problems, and listened carefully to the enterprises in product registration declaration, clinical trial evaluation, production quality management and other aspects of the comments and suggestions. (CFDA website)