Surgical face masks – filtering out counterfeit copies
Despite this, the public have clamoured to arm themselves with face masks. The global press has reported on this unprecedented run on face masks in Mainland China and Hong Kong (and globally) which has resulted in a significant lack of availability. Given the demand, it is not surprising that there are widespread reports of counterfeit masks being sold online and in physical shop premises.To get more news about
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This article discusses the key IP and regulatory issues relating to surgical masks and penalties for the production of counterfeit products.Surgical masks are specialist pieces of medical equipment designed predominately for use in the hospital environment to protect patients and healthcare staff from spreading and contracting disease. In general, a basic surgical mask has three layers: the innermost layer is used for absorbing moisture (from the wearer’s breath, cough, sneeze etc.), the middle layer is a filter (for particles and infectious agents) and the outer layer repels liquid (e.g. water, blood etc.). There are varying levels of quality for surgical masks and the extent of protection depends on the specifications of manufacture. To ensure the quality and protection of these products, relevant standards exist for their manufacture. As an example, two regularly cited standards are the EU and US standards:
There are also Chinese Standards for surgical masks (GB 19083-2010 Technical Requirements for Protective Face Mask for Medical Use, YY 0469-2011 Surgical Masks) that provide the mandatory specifications for these products in China.
As evidenced by these standards, the manufacturing of a surgical mask must be undertaken with some degree of precision. If the product does not meet these specifications, they may not function as required and place the wearer at significant risk.Surgical masks are regulated as a medical device in Mainland China but, while they are also classed as a device in other parts of the world, there are no specific legislative requirements for the regulation of medical devices in Hong Kong.
For China, the “Medical Device Classifications Catalogue” (effective 1 August 2018) lists both surgical mask (141304) and protective face mask for medical use (141401) as Class II medical devices. This classification places legislative requirements on the product in terms of specifications, license to manufacture, quality control and recording of business operations. In addition, if the products are to be sold online, there are now also specific measures that must be taken to offer online sales of medical devices.
Given the potential risk associated with surgical masks that do not meet the stated requirements, there is a general concern by governments and manufacturers that fake or counterfeit products may infiltrate the market. As local media in both Hong Kong and Mainland China continue to report instances of counterfeit masks being found for sale on major online platforms and retail outlets, the government in both jurisdictions have been quick to respond. In Hong Kong, customs officers launched a territory wide operation (codename – Guardian) on January 30 to inspect retail locations selling surgical masks. This resulted in the seizure of 68,000 suspected counterfeit masks at one location and the arrest of the shop’s proprietor. Similar counterfeiting issues have been evident in Mainland China. One example in recent weeks was the seizure of 50,000 fake masks in Yiwu, a manufacturing hub in the eastern Zhejiang province.
The TDO makes it an offence to use false trade descriptions for products in Hong Kong (e.g. falsely claiming compliance to a standard specification). Part 2 of the TDO states: “any person who supplies goods with a false trade description in the course of trade or business, or is in possession of any goods for sale with a false trade description, or sells or possesses for sale any goods with a forged trademark commits an offence. The maximum penalty upon conviction is a fine of HK$500,000 and imprisonment for five years”.
