• 2020-02-21 07:07:01

For both GN-21 and GN-34, HSA added guidance regarding notification of software changes in In Vitro Devices (IVD) .

• 2020-05-06 07:14:30

HSA warns the public risk of Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) on breast implants. HSA provided regulatory control currently in place to lower the risk of the device to existing and future patients in Singapore.

• 2020-05-06 05:39:48

HSA constantly improves the quality of guidance documents with the periodical revision of the same. Just recently, HSA made minor revisions for GN-02 and GN-15.

• 2020-05-06 05:29:23

HSA has conducted an industry briefing last March 28, 2019 regarding the guidance revision for Change Notification (CN) which aims to address typical concerns that results in confusion among stakeholders. Additional updates on the requirements for CN applications were also added.

• 2020-05-05 08:05:23

HSA requires Class A devices to be listed in SMDR database prior to importation and selling in Singapore. GN-22 includes this list of Class A medical devices of which an item was recently revised by HSA.

• 2020-05-05 07:53:33

HSA introduced evaluation routes to hasten the registration of high-risk devices. GN-15 contains the details of each routes. The latest update for GN-15 (version 7.2) improves the criteria for class B devices to undergo Immediate Class B Registration (IBR) Evaluation Route.

• 2020-05-05 07:40:26

HSA uses post market monitoring in ensuring the safety of medical devices entering the Singapore market. GN-10 guides manufacturers on the steps in reporting hazards to these medical devices. HSA released version 3.5 of GN-10 with minor revisions last January 2019.

• 2020-05-06 05:36:45

Using the available digital technologies, HSA is seeking to improve their Post Market Surveillance mechanism via Field Safety Corrective Action (FSCA) reporting. Last March 2019, has introduced OSCAR, their new Online System which will serve as a one-stop platform for FSCA.

• 2020-02-12 14:17:57

The update guidance includes "risk classification", "licensing of manufacturer", "Field safety corrective action", product registration"... and other registration related documents.

• 2020-02-12 15:01:28

In order to effectively inform the stakeholders of these new regulations, HSA Medical Branch published the updated documents containing the overview of the whole Singapore regulation unto their website.