Hong Kong Updates its Medical Device Regulation for Change Notifications

On December 22, 2023, Hong Kong’s government issued a new update (GN-10) to its Medical Device Administrative Control System (MDACS). It is the Hong Kong local agent’s job (local responsible person or LRP) to report product registration changes and update the MDACS. A major change to a device, including a change that will affect its safety or performance, must be submitted within 12 weeks of the expected utilization. Minor changes, everything not considered a major change, must be submitted within 24 weeks of the expected utilization. Once a change notification is submitted to the Hong Kong Medical Device Division (MDD), the Hong Kong LRP will be notified within 2 weeks.

In some cases, a change notification will not be accepted, and instead, a new application will be needed. For example, if the original device manufacturer is purchased, the new product owner will need to submit a new application. If a change notification is declined, the LRP cannot go forward with the change, and if this result is not carried out, the existing device registration will become invalid. In situations where the change notification is accepted, the LRP will need to surrender the original certificate, and a new one will be issued. Please remember device registration is still only voluntary in Hong Kong. However, medical institutions strongly prefer to buy devices on the voluntary list. Also, once on the voluntary list, you will be in the front of the line when Hong Kong medical device registration becomes mandatory.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.