On February 25, 2026, the Medical Device Division (MDD) of Hong Kong updated its webpage providing useful information regarding the Medical Device Listing Application process. The key update includes providing a list of documents essential to medical device listing application under the Medical Device Administrative Control System (MDACS) (the List).
Read the full update here: https://www.mdd.gov.hk/en/mdacs/listing-application/medical-device-listing-application/index.html
Scope of Application
This update applies to:
- Applicants submitting medical device listing applications through the Medical Device Information System (MDIS)
- Medical device manufacturers
- Local Responsible Persons (LRPs)
Key Highlights
- The webpage now includes a list of documents essential to medical device listing application under MDACS.
- The Local Responsible Person (LRP) should include all required documents when submitting a medical device listing application through MDIS.
- The LRP must ensure that all documents are complete and properly prepared prior to submission.
- The MDD may request additional information during the review process, such as original documents, certified copies, or additional labelling samples.
- If the requested information is not provided (within 14 calendar days), the application may be closed.
- Refer to the official document: Documents Essential to Medical Device Listing Application under MDACS
Implications to Clients
Manufacturers should work and collaborate closely with their Local Responsible Person (LRP) to ensure that all required documents are complete and properly prepared before submitting the device listing application through MDIS.
Applicants should be prepared to provide additional information or documents if requested by the Medical Device Division during the review process.
Timely submission of requested information is critical, as failure to comply may result in processing delays or closure of the application.
Effective Date
Immediate effect
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Hong Kong, please contact info@nordpacificmed.com