Reporting requirements for defective products

Government notification

What requirements are there to notify government authorities (or other bodies) of defects discovered in products, or known incidents of personal injury or property damage?

The Consumer Goods Safety Ordinance imposes a statutory obligation to warn. Section 7 of the Ordinance provides the Commissioner with the power to serve a notice to require a person, at his or her own expense and by his or her own arrangement, to publish a warning that the consumer goods may be unsafe unless steps specified in the notice are taken.

Notification criteria and time limits

What criteria apply for determining when a matter requires notification and what are the time limits for notification?

A matter requires notification as long as the Commissioner reasonably believes that the consumer goods are unsafe in certain circumstances.

Competent authority

To which authority should notification be sent? Does this vary according to the product in question?

The sending of notification varies according to the product in question.

For food products, reports or complaints may be referred to the food trader, who should immediately notify the Food and Environmental Hygiene Department.

For pharmaceutical products, reports or complaints may be referred to the licensee, who should then report the problem to the Department of Health by filling out a Pharmaceutical Product Problem Report Form (Part 1). Serious problems that may lead to the recall of products must be reported to the Department of Health within 24 hours of receipt of the complaint or report for investigation.

Notification information

What product information and other data should be provided in the notification to the competent authority?

The product information and other data provided in the notification vary according to the product in question.

For example, for pharmaceutical products, the Pharmaceutical Product Problem Report Form (Part 1) should be filled out when notifying the authority. Information in relation to the details of the problem (ie, reporting company’s contact details, source of complaint, description of the problem, etc) and details of the product (eg, product registration number, manufacturer details, importer details, etc) should be included.

Obligations to provide updates

What obligations are there to provide authorities with updated information about risks, or respond to their enquiries?

Under the Consumer Goods Safety Ordinance, there is no obligation to provide authorities with updated information about risks. However, there is an obligation to respond to their enquiries. Section 10 of the Consumer Goods Safety Ordinance provides that the Commissioner may require the manufacturer, importer or supplier to test certain consumer goods in the form and manner the commissioner specifies.

However for food products, the traders must conduct follow-up action by providing a progress report at regular intervals at the request of the Department. After food recall is exercised, the trader should submit a final report within a specified time frame determined by the Department. As for enquiries, the Department may assess the adequacy of the food trader’s action. For example, whether a prompt announcement of recall or prohibition of supply or import through the media was made, whether convenient and adequate locations for return of the food was made, and whether proper record of the recalled food is kept by the traders.

Penalties

What are the penalties for failure to comply with reporting obligations?

Section 28 provides that a failure to comply with a notice served by the Commissioner is an offence. A person who is found guilty under this offence is liable to a fine at level 6 (HK$100,000) and to imprisonment for one year on the first conviction, and to a fine of HK$500,000 and to imprisonment for two years for subsequent conviction.

Public disclosure

Is commercially sensitive information that has been notified to the authorities protected from public disclosure?

No.

Use of information in prosecution

May information notified to the authorities be used in a criminal prosecution?

Yes.