CHINA Law and Practice Contributed by: Yue Dai, Zhenghao Li and Xiaokun Yuan, King & Wood
ger compromising personal and/or property safety are found in the same batch, model number or type of consumer goods, due to issues with the product design, manufacturing, warning, etc. Recall informa - tion must be published in a “well-known” publication that is easily accessible to the public. Such well- known publications include newspapers and periodi - cals, 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 regulations, 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 automotive product due to issues with prod - uct 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 Provisions on Administra - tion of Motor Vehicle Emission Recalls, China has also introduced an emission recall system for motor vehi - cles, under which vehicle manufacturers are required to recall motor vehicles with “emissions 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 notifica - tion time limits, and the recall announcements require
different levels of media exposure, according to the class. The Measures for the Administration of Medical Device Recalls require “medical device manufactur - ers” (including the medical device registrant or filing holder, or the domestic agent appointed by the over - seas manufacturer of imported medical devices) to be responsible for co-ordinating product recalls. How - ever, it should be noted that under the latest Regula - tion on the Supervision and Administration of Medical Devices, the recall obligation explicitly lies with the medical device registrant or filing holder – including Where a manufacturer or a seller has discovered a defect in its goods or services, which may harm personal safety or property security, it must immedi - ately report the defect to the relevant administrative authorities. This reporting obligation is widely required in many recall regulations for specific products. Under the Measures for the Implementation of the Regulation on the Administration of the Recall of Defective Auto Products, upon learning of potential defects in its automobile products, the manufacturer must organise an investigation and analysis thereof, and truthfully report the result to the SAMR. Sellers, repairers, rental service providers or spare part manu - facturers are also required to report any defects they identify in their business operation to the SAMR and notify the manufacturer of such information. those of the imported medical devices. 1.4 Obligations to Notify Regulatory Authorities Under the current Measures for the Administration of Medical Device Recalls, a medical device manu - facturer must immediately report any of its medical device products that are found to be defective to the provincial food and drug supervision and administra - tion department. Medical device operation enterprises and users are also required to immediately report to their provincial food and drug supervision and admin - istration department and notify the manufacturer or supplier of defects. In particular, if the medical device user is a medical institution, it must also report device defects to its provincial health administrative depart - ment. Please also note that, as discussed in 1.3 Obli-
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