In late 2015, the Medical Device Branch (MDB) of Singapore’s Health Sciences Authority (HSA) released updated guidance documents on the Change Notification System for Registered Medical Devices. The updates to the guidance documents are intended to make the notification process more efficient and streamlined, and went into effect on December 1, 2015.
Changes that require notification:
The three categories of changes that would require submission of change notifications to the HSA before implementation are:
- Technical changes (class C and D)
- Review changes (class A and B) medical devices
- Administrative changes
Key revisions:
- Adding a medical device with proprietary names different from the registered device will not qualify for change notification. This requires a new pre-market registration with the HSA.
- New models of a registered medical device listing will now fall under the Review Change category.
- When a change is due to an adverse event or ongoing field safety corrective action, manufacturers of all classes must seek prior approval (unless they have written advice from HSA that states otherwise).