Recently, based on in-depth research and extensive views from various parties, Qinhuangdao Food and Drug Administration unveiled “Qinhuangdao Implantable Medical Devices Regulations (Trial)” to increase the full supervision of implantable medical devices, especially such sectors as equipment off-site management and procurement of medical institutions to ensure patients' safety in equipment application.

The Administration spent three months selecting 8 from 19 hospitals which carry out implantation and doing in-depth research to better protect public safety of equipment application. According to the research, the Administration organized a forum in which Deans, Directors of Department of Pharmacy (Equipment Division) and clinical experts of 19 medical institutions and 33 sales heads in charge of implantable medical device enterprises participated. After listening to opinions from all sides many times, the Administration unveiled “Qinhuangdao Implantable Medical Devices Regulations (Trial)”. With highlighting the product quality assurance and traceability as the main line, the Regulations makes comprehensive detailed regulations on procurement, inspection, warehousing, storage & maintenance, delivery from storage, use, follow-up, quality tracking, destruction, unqualified product handling and adverse event reports of implantable medical devices, and requires that companies and medical institutions shall establish and improve and strictly implement the system to ensure that there are appropriate records of all links to make sure that products can be traced and controlled. Such illegal activities as private warehouse, off-label business, procurement of medical equipment from illegal sources, the use of counterfeit medical devices and so on will be severely punished according to “Qinhuangdao Implantable Medical Devices Regulations (Trial)”.

Source: China Pharmaceutical News