Revised Medical Device Change Notifications in Singapore
The Health Sciences Authority (HSA), Singapore’s medical device market regulator, has announced changes to the country’s change notification process for field safety corrective actions (FSCA) that will go into effect October 1, 2014.
By revising the change notification process, the HSA is aiming to allow any safety-related corrections to be more efficiently made to existing medical device supplies on the Singaporean market. Under the current process, manufacturers making any changes to their devices that impact safety, quality or efficacy must submit change notifications for HSA approval via the Medical Device Information & Communication System (MEDICS).
Changes to Change Notification
Starting October 1, the HSA change notification process will include the following revisions:
- For existing supplies of a medical device, FSCA notifications may also be used as change notifications according to Regulation 49
- Fees for change notifications involving existing supplies would not be triggered until submissions are made to MEDICS
- For new supplies of a device, any FSCA pertaining to safety, quality or efficacy will require the manufacturer to submit a change notification via MEDICS for regulatory approval
FSCA strategies urged
Failure to submit change notifications and initiate FSCAs can have significant consequences for manufacturers selling their devices in Singapore—up to and including cancellation of HSA registration. Regulators recommend that market registrants develop adequate FSCA strategies in order to avoid noncompliance issues.
In the event of a FSCA, a manufacturer or importer should first determine whether any existing supplies of its device on the market in Singapore are affected. All relevant manufacturing, importation and distribution data concerning the device in question should be compiled, and a working correction schedule for the FSCA should be developed.
Consulting with HSA, the manufacturer should determine whether its FSCA warrants a full change notification; if so, existing supplies of the device in question as well as new shipments en route to Singapore that are affected by the change notification should be identified.
Finally, a proper FSCA strategy should include processes for documenting root causes as well as corrective and preventative actions (CAPA).