医疗器械召回管理办法—英文版.pdfVIP

Ministry of Health of People’s Republic of China Ordinance No. The Regulation of Medical Devices Recall Administration (Test) was approved by the Conference of Ministry of Health on June 28th 2010, and will be activated on July 1st 2010. The Regulation of Medical Devices Recall Administration (Test) Chapter 1 General Guideline Article 1 For better supervision of Medical Devices, to guarantee people ’s health and well-being, according to The Administration of Medical Devices, and State Council: About the Special Rules for the improvement of Food and Food Safety, this legislation is drafted. Article 2 This regulation applies to Medical Devices sold within PRC. Article 3 The definition of Medical Devices recall refers to the actions taken to eliminate the defects of the already sold devices, such as warning, checking, re-labeling, fixing, amending, and completing user ’s guides, software updating, replacing, recalling, and destroying of a certain line or model. Article 4 The defects mentioned above refers to the medical devices that may be of unreasonable safety or health hazards to people when operated under normal conditions. Article 5 1 / 12 The major force of the controlling and eliminating of defective products are the manufacturers of medical devices, therefore these companies are to take full responsibilities for the safety of their products. Article 6 Under this regulation, the medical devices ’ manufacturers are to establish and perfect their recalling system, to collect the related information regarding the safety of their medical devices, and to investigate, estimate their possible defective products, in order