Medical equipment and health of people's lives, if a problem, medical device manufacturers must implement the recall. "Medical Device Recall Management (tentative)" (hereinafter referred to as the "Rules") by the Ministry of Health issued Decree No. 82, digital blood pressure monitor came into effect from this month. I understand that the "measures" into force, under normal use, there are security risks of medical devices will be recalled, a security risk rather than a voluntary recall of medical devices business will be severely punished,digital thermometer manufacturer if the medical device recall damage to the patient, the patient can seek compensation. In addition, multinational Medical Equipment Company in the global recall of Chinese exclusion phenomenon will also be eliminated.
What kind of medical equipment to be recalled
"Normal use there is likely to endanger human health and safety of unreasonable risk medical devices", are "measures" referred to recall.
Medical Device Recall refers to the medical device manufacturer in accordance with the procedures provided for its sale of defects has been of a class, type or batch of products, take warning, inspection, repair, re-label, modify and improve the manual,digital thermometer software upgrade, replace, recover, destruction, etc. to eliminate defects in behavior.
Medical device manufacturers to control and eliminate product defects subject, should be responsible for the safety of their products. Medical device manufacturers should be required to establish and improve medical device recall system, the safety of medical devices to collect information on defective medical devices may investigate, assess, and timely recall of defective medical devices.
Medical equipment enterprises, and use find their business, the use of defective medical devices, they shall immediately suspend the sale or use of the medical device, medical device manufacturers promptly notify the supplier or to the drug regulatory department report; use units medical institutions, should also be at the same time to the health administration department.
China will no longer be excluded from the recall beyond the
Since the method applies to "sales in the PRC, the medical device recall management and supervision," which means that also applies to imports of medical equipment. Experts believe that this will regulate multinational medical device companies in China to recall.
According to publicly available data, in 2010, breaking the one hundred billion output value of China's medical equipment, but, the local device company focused on the routine consumption of more varieties of low-end market, NMR, CT high value-added large-scale equipment market was almost GE, Siemens , Philips and other foreign companies to monopolize. "Measures" implemented, including Johnson & Johnson, including a number of multinational companies in the global recall of Yi Xie, China can no longer take exception to the grounds of relief recall responsibility.
This, according to the "measures" requirements, the import of medical equipment manufacturers in the extraterritorial application of foreign medical device recall, it shall notify its designated agent in China and timely reporting of SFDA; in the territory of the recall, must be its designated agent in China is responsible for the specific implementation required.
Food and drug regulatory departments of the responsible person, this one will help to eliminate some of the medical device multinational companies engaged in international product recall, the Chinese exclusion phenomenon.