To consolidate 2014 medical equipment "five regulation" initiative to further standardize the order in the medical device market so far this year, Guangzhou's food and drug administration carefully in accordance with the General Plan of national Office, provincial Council, guided by the risk, clue to complaint as the main line, targeting key enterprises in order, through the "four measures" focus medical equipment "five regulation."
A verification to brush. "Five regulation" violation complaints admitted during the period, as well as investigating Combs, verify whether the risks and substandard products take the corresponding measures, corrective action is in place, establish whether perfect systems and mechanism, Chiang, a base out.
Second, focus. To plant (between) into class medical devices, and body outside diagnosis reagents, and oral material, and contact lenses, and one-time using three class no bacteria medical devices, high-risk varieties for focus, from business and using units purchased into channel, and business qualification, and cable card cable votes, and store environment, and system implementation and specification records, link starts with, main identification medical devices registered card, and products certificate Ming whether complete, has no medical devices false registered declared, and violations production, and illegal business, and exaggerated publicity, and using no card products, illegal violations behavior.
Third, flexible, looking back. Investigations investigations, special raids and interviews visit or in other ways, with routine inspections, risk classification, advertising monitoring, complaint reports combine and organize forces to look the previous problems discovered in the inspection, continue troubleshooting, regulation, standard, flexible and look back at the entire cover, leaving no dead ends, special action to ensure smooth development.
Four high voltage regulation. "Look," discovered in the inspection of medical device registration, production, management, publicity and use of five illegal questions, insist on outcrops and "strict, from heavy, fast" principle, continues to create a crack down on high-voltage situation. Unit for rectification of the problems are not in place dealt with tolerance, firmly consolidate the special achievements.