License maintenance is an important consideration for manufacturers selling medical devices in Hong Kong as failures to comply could lead to importation delays or loss of market access. License Maintenance in Hong Kong consists of maintaining labeling compliance and obtaining approval prior to importing products that have changed from the original Registration Certificate.
Any changes that are made to your product, labeling or manufacturing process may require an amendment, or fresh application, to maintain compliance and continued access to the Hong Kong market. Examples of eligible changes include the trader’s address, adjustment to model numbers, and some device design changes.
Listed devices marketed in Hong Kong should bear the Special Listing Labeling, which shows the Hong Kong listing number and the contact details of the Local Responsible Person (LRP). The label will need to be displayed on the outer packaging of every device or sales unit or on a document delivered together with the device.
4.4.13 Special Listing Information
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.
The following changes to your product will require Asia Actual to submit a Registration Modification to the MDD. If you are considering changes to your product, please reach out for support evaluating whether a modification will be required.
Modifications typically require about 3 months from submission to receive approval. The following are examples of permissible modifications:
Change to manufacturing site
Change in sterilization method
Change of material
The following examples of changes to your product will require a NEW Registration.
Significant change to, or additional, Intended Use
Significant change to mode of operation
Notice: Interpretations of permissible modifications can vary and it’s important to always check with your License Holder or Regulatory Professionals when considering new changes to maintain compliance and avoid losing market access.
Contact Asia Actual to learn more about the license maintenance requirements for your medical device.