HONG KONG SAR, CHINA Law and Practice Contributed by: Gordon Chan
1. Product Safety 1.1 Product Safety Legal Framework Main Laws and Regulations
• Public Health & Municipal Services Ordinance (Cap 132) – regulates the quality of food on sale for human consumption and drugs; • Food Safety Ordinance (Cap 612) – applies to food products and requires the implementation of food tracing and record-keeping mechanisms; • Pharmacy and Poisons Ordinance (Cap 138) and Dangerous Drugs Ordinance (Cap 134) – applies to pharmaceutical products, poisons, and dangerous drugs; • Chinese Medicine Ordinance (Cap 549) – applies to proprietary Chinese medicine and traditional Chinese herbal medicine; and • Dangerous Goods Ordinance (Cap 295) – applies to dangerous goods such as explosive, flammable, radioactive, or corrosive substances, as well as compressed gases. At the moment, medical devices in Hong Kong are only subject to a voluntary, non-legal regulatory regime, the “Medical Device Administrative Control System” (MDACS). Note also that the Trade Descriptions Ordinance (Cap 362) prohibits false or misleading claims about prod - uct safety or quality. 1.2 Regulatory Authorities for Product Safety In Hong Kong, a number of government departments and statutory bodies oversee product safety. The Customs and Excise Department (C&ED) serves as the primary law enforcement agency for general consumer product safety. It enforces the Consumer Goods Safety Ordinance (Cap 456), the Toys and Children’s Products Safety Ordinance (Cap 424), the Trade Descriptions Ordinance (Cap 362), and related subsidiary legislation. The C&ED has the power to investigate suspected unsafe consumer products, conduct market surveil - lance and testing, and take enforcement action when goods do not meet applicable safety requirements or have applied false or misleading descriptions. It also has the power to initiate criminal prosecution against the suppliers, manufacturers, importers and sellers of the goods in question.
The main laws and regulations on general product safety in Hong Kong are based on the following com - mon law and statutes: • Claims of tort in negligence – a civil action for the breach of duty of care against a product manufac - turer, supplier, distributor, etc; • Claims in Contract – a civil action for breach of the express or implied terms of a contract; • Sale of Goods Ordinance (Cap 26) – regulates general goods for sale to be of merchantable (sat - isfactory) quality, fit for purpose, as described on the package and sign, and corresponding with the sample; • Consumer Goods Safety Ordinance (Cap 456) – the core legislation for consumer goods ordinarily supplied for private use or consumption, it imposes a general duty that goods be reasonably safe in all circumstances; and • Consumer Goods Safety Regulation (Cap 456A) – subsidiary legislation dealing with practical compliance issues, including warning and cau - tion labelling requirements, which must be shown clearly and be in both English and Chinese, where applicable. Product-Specific Laws and Regulations Numerous product-specific laws and regulations exist. Examples include the following: • Electricity Ordinance (Cap 406) and the Electrical Products (Safety) Regulation (Cap 406G) – applies to household electrical products supplied in Hong Kong and requires compliance with essential safety requirements; it also includes certification of safety compliance requirements for relevant electrical products; • Toys and Children’s Products Safety Ordinance (Cap 424) – applies to toys and specified children’s products and requires compliance with prescribed safety standards rather than relying only on the general safety requirement under the Consumer Goods Safety Ordinance;
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