On November 25, 2015, the Medical Device Branch of the Health Sciences Authority of Singapore released the updated guidance on the change notification requirements for registered medical devices in Singapore (the Guidance). The Guidance became effective December 1, and applies to change notification applications submitted on or after that date. We summarize its highlights below.
Purpose and scope
The Guidance provides clarity to registrants of medical devices on the Singapore Medical Device Register (Registered Devices) to determine whether a change notification in relation to any Registered Devices must be filed with the Health Sciences Authority (the Authority) before the registrants make any modifications to such Registered Devices.
The Guidance applies to all Registered Devices and sets out criteria in determining when a change notification must be filed in relation to any Registered Devices.
Changes that require notifications
There are three categories of changes that would require submissions of change notifications to, and approval by, the Authority before implementation of the changes:
- technical changes for Class C and D medical devices
- review changes for Class A and B medical devices, including addition of new models, removal or revision of warnings, and modification of approved method of use
- administrative changes, including changes to the administrative documents and information submitted at the time of registration of the medical device
In addition, notification changes may be implemented immediately on receipt of the acknowledgment email from the Authority after a registrant’s submission of the notification through the Medical Device Information & Communication System (MEDICS). However, the foregoing does not apply to notification changes in the context of, nor as a consequence of, a reportable adverse event or field safety corrective action.
Changes when a new submission of registration is necessary
The Guidance states that some changes to the Registered Devices will require a new submission of a pre-market product registration, including these:
- changes to the intended purpose of a registered medical device
- changes to the risk classification of a registered medical device
- additions of a model that does not fulfill the grouping criteria, including permissible variants, as listed in GN 12 Guidance on Grouping of Medical Devices for Product Registration
- changes to the medicinal substance in a device that incorporates a medicinal product in an ancillary role
- additions of medical devices with device proprietary names different from the registered devices into a device listing