What is FSCA
A FSCA is any action taken to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device. It is required when it becomes necessary for the medical device product owner to take action to eliminate,
or reduce the risk of, the identified hazards.
A FSCA includes:
- The return of the medical device to the product owner.
- Replacement or destruction of the medical device.
- Any action regarding the use of the medical device that is taken in accordance with the advice of its product owner.
- Permanent or temporary changes made to the labelling or instructions for use of the medical device.
- The clinical management of any patient who has used the medical device.
- Modification of the medical device.
- Retrofitting the medical device in accordance with any modification to it or any change to its design by its product owner.
- Upgrading any software used with the medical device, including any such upgrade carried out by remote access.
You need to report a FSCA if the affected device meets any of the following criteria:
- The medical device has been manufactured, imported or supplied in Singapore
- The medical device has been registered or given special authorisation for local supply
Who to report
The reporting person should be the dealer that manufactured, imported, supplied or the product registrant for the affected devices. In cases where more than one dealer is involved, they may be required to make individual reports.
- Before initiating a FSCA, the dealer has to notify HSA. In cases where more than one dealer is involved, each dealer will need to report the FSCA individually.
- Once reported to HSA, the dealer can proceed to initiate it without waiting for an approval from HSA.