Hong Kong

Hong Kong License Maintenance

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. Learn more about the Local Labeling requirements in Hong Kong here.

Registration Modifications

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.

Contact Us

US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: Hongkong@asiaactual.com

Hong Kong

Hong Kong License Maintenance

Registration Modifications

Hong Kong Regulatory Support

Hong Kong Sales Support

Contact Us

Latest Market Updates

Asia Actual, LLC

Asia Headquarters