CHINA Law and Practice Contributed by: Yue Dai, Zhenghao Li and Xiaokun Yuan, King & Wood Mallesons
emergency steps to take to avoid damages or harm. Implementing Product Recalls A manufacturer is required to make a recall when it is informed, by way of self-check, reports or complaints by the general public, or notification from a regulatory department, that the prod - ucts it produces or sells are defective. Where the manufacturer fails to make a recall, or the relevant quality inspection departments deem it necessary, the regulatory authorities may order a product recall to be conducted. Detailed proce - dures and requirements for conducting product recalls are usually found in the regulations for specific products as discussed below. Recall of consumer products The Interim Provisions on the Administration of Consumer Product Recalls Defects regulate the recall of consumer products. Under the regu - lations, recall is necessary when defects that could cause unreasonable danger compromis - ing personal and/or property safety are found in the same batch, model number or type of consumer goods, due to issues with the prod - uct design, manufacturing, warning, etc. Recall information must be published in “well-known” publication that is easily accessible to the public. Such well-known publications include newspa - pers and periodicals, websites, and radio and television channels. Recall of defective automotive products The Administrative Regulations on the Recall of Defective Automotive Products regulate recalls of automotive products. According to these reg - ulations, the SAMR supervises and administers the recall of defective automotive products in China. When defects are found to exist in the same batch, model number or type of automo - tive product due to issues with product design,
manufacturing or labels, a manufacturer must prepare a recall plan, communicate the plan to the automobile sellers, and file the plan with the SAMR. The manufacturer is also required to release recall information in an easily accessible manner to the general public. In addition, pursuant to the Administrative Regu - lations on Motor Vehicle Emissions Recall, China has also introduced an emission recall system for motor vehicles, under which vehicle manu - facturers are required to recall motor vehicles with “emission hazards” . The emission recall regime is administered by the SAMR jointly with the Ministry of Ecology and Environment. Recall of medical devices Under the Measures for the Administration of Medical Device Recalls, medical device recalls are divided into three classes according to the severity of the defects: • Class I recall – use of the medical device may cause or have caused serious health hazards; • Class II recall – use of the medical device may cause or have caused temporary or reversible health hazards; and • Class III recall – use of the medical device has a lower likelihood of causing a hazard but such medical device still needs to be recalled. The different classes of recalls follow different notification time limits and the recall announce - ments require different levels of media exposure, according to the class. The Measures for the Administration of Medical Device Recalls require “medical device manufac- turers” (including the medical device registrant or filing holder, or the domestic agent appointed by the overseas manufacturer of imported medi - cal devices) to be responsible for co-ordinating
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