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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.
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.
Hong Kong Regulatory Support
US: +1 512 898-9222
Latest Market Updates
- Hong Kong Refines Medical Device Post-Market Surveillance Report FormJanuary 27, 2023 - 10:25 am
- Hong Kong to Pilot Prioritizing Some Listed Medical DevicesAugust 30, 2022 - 8:55 am
- How New EU MDR Requirements Will Affect Registrations in AsiaAugust 12, 2022 - 2:07 pm
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- Hong Kong’s MDD Formalizes Expedited Approval SchemeJanuary 21, 2022 - 2:27 pm