The recall of defective medical devices is an international practice, the protection of public safety with firearms played an important role, but also reflects the medical device manufacturer is responsible for product quality concept. For the gradual establishment of a sound regulatory practice in line with our medical device recall system, "Medical Device Recall Management (tentative)" (hereinafter referred to as the "Rules") has recently been introduced on July 1, come into force.China promulgated the "Measures for the Administration medical device recalls."

"Approach" chapters thirty-eight were, respectively, from medical device regulatory system, recall, recall of the grading and classification, liability and other aspects of medical device recall management of the work made specific provisions, including the specific characteristics of :

First, the core issues with international practice.

What kind of medical equipment for the needs of the recall, is the enactment of this "approach" the core issue. "Rules" draw the United States, European Union, the definition of defective product recall of the recalled products were limited: "The term medical device recall, refers to the medical device manufacturer in accordance with the procedure laid down their already sale of a defective type, model or batch of products, take warning, inspection, repair, re-label, modify and improve the manual, software upgrade, replace, recover, destruction, etc. to eliminate defects in behavior. "

Second, the reference drug recall system, from the contents of the framework, regulatory regime, the recall classification and classification, and legal responsibilities to establish three major medical device recall management system.

In the medical device regulatory system, the recall, "method" specified in Article VIII of the medical device recall the provincial Food and Drug Administration (Drug Administration) based regulatory regime. Grading and classification of the recall, "method" under Article XIII of the severity of defects in medical devices descending order, the recall is divided into three; the same time, the medical device into a voluntary recall and ordered recall recall two, and set up a "voluntary recall" and "ordered the recall of the" two chapters provides medical supervision and implementation of management procedures and the specific content. Legal responsibility, "means" do not fulfill the statutory obligations of the recall set the punishment.

Third, according to the characteristics of medical device regulation to make special regulations.

Medical disciplines involved in large span, breed in various categories, a high degree of technical complexity. "Approach" clearly defined definition of medical device recalls and product recalls are handled, in the "medical device recall" is defined, in addition to emphasis on product defects, but also highlights the medical device recall, not only can recover product, you can also take warning, inspection, repair, re-label, modify instructions, software upgrades, replacement and other methods to eliminate defects; details the medical device recall of products after treatment measures. Meanwhile, the "way" to define the contents of the recall notice. Medical device manufacturer in making the recall decision, should be notified as soon as the enterprises, and use or to inform the user, control products prevent the recurrence of injuries. In order to increase maneuverability, "approach" provides the specific content of the recall notice.

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