Sep 17, 2014

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).

Author

  • Stewart Eisenhart

Related

Faster Market Pathway in Effect for Higher-Risk Devices in Singapore

Singapore’s medical device market regulator, the Health Sciences Authority (HSA), has set up expedited registration routes for higher-risk Class C and D devices in the country beginning January 1, 2013 in order to improve public access to new medical technologies. Similar expedited registration routes were launched by the HSA in 2012 for lower-risk Class A and B devices.

Read more

Singapore Eases Market Entry for Lower-Risk Devices

In a move likely to boost interest in the Singaporean medical device market, the Health Sciences Authority (HSA), Singapore’s medical device market regulator, plans to implement new rules effective May 1 to provide expedited market access for lower-risk devices.

Read more

Progress Reported on ASEAN Medical Device Directive in Southeast Asia

A recent meeting of Southeast Asian economic ministers in Myanmar has yielded a formal signing of an agreement between 10 nations to establish a harmonized medical device registration framework.

Read more

Have questions on what Emergo can do for you?

CONTACT US