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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
- NMPA to Pilot Program Allowing Hong Kong Approved Products to Be Sold in Mainland ChinaDecember 16, 2020 - 4:59 pm
- Voluntary Medical Device Registration in Hong KongJuly 10, 2020 - 11:17 pm
- HONG KONG EXTENDS PILOT PROGRAM TO RECOGNIZE CHINA AND KOREA AS REFERENCE COUNTRIESJune 10, 2020 - 8:00 pm
- MEDICAL DEVICES SHIPMENTS DURING THE COVID-19 PANDEMICJune 4, 2020 - 8:28 pm
- 4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIAOctober 2, 2019 - 6:51 pm