Medical device labeling requirements in Hong Kong for listed devices are laid out in the Special Listing Labeling. In addition to information on the international label, Hong Kong requires the HK listing number and the contact details of the Local Responsible Person (LRP) in English and Chinese (Kaishu font type with and all characters should not be less than 2mm high) text.
The Special Listing Information of a medical device comprises (i) and (ii) below:
The device’s Listing Number, and in case the device’s instructions for use are available only in English or only in Chinese, a supplementary statement to inform the user of this fact. The information shall be displayed in the applicable format shown in Fig. 1 below.
The LRP information including the name, address and contract telephone/fax numbers in both English and Chinese wherever applicable.
The LRP shall provide the Special listing Information by complying with either Option (I) or Option (II) below. The LRP will have a grace period of six months after the device is listed to meet this requirement.
The information (i) shall be displayed on the outer packaging of every device or sales unity; and
The LRP information (ii) shall be displayed on the outer packaging of every device or sales unity, or on a document delivered together with the device.
Measures shall be implemented by the LRP such that whenever the listed devices are supplied and delivered to the end-users or user facilities with or without cost to them, the deliver shall include a document on which the Special Listing Information is printed or otherwise permanently documented (This requirement does not apply to any subsequent sales from the end-users or user facilities); and
The LRP shall be ensure support from all concerned importers, distributors and retailers to implement the measures in (a). This option shall not be adopted if cannot be effectively implemented.
Fig 1. If the instructions for use are available in both English and Chinese languages, the format in figure (a) shall be applied. The format in figure (b) or (c) shall be applied if the instructions for use are available only in Chinese or only in English.
Whenever figure (a), (B) or (c) is applied, it shall be with a printed rectangular border as shown. All the characters shall be of a uniform font size of not less than 2mm high. In (c) the Chinese characters shall be in kaishu.
Changes to Medical Device Labeling
Any changes/updates to the Instructions for Use (IFU) or the device labeling will require an amendment application to be submitted to the MDD.
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