Singapore

OSIM International Pte. Ltd. has registered a product with the FDA under code ION.

GOLDEN SEASON PTE LTD has registered its medical device with the FDA under product code FPP.

Emerald Medical Services Pte. Ltd has registered with the FDA under product code LOX.

The Health Sciences Authority launched a pilot Change Management Program for Software as a Medical Device, including ML-enabled SaMD.

Guidance provided for decontaminating single-use respirators amid the COVID-19 pandemic.

The Health Sciences Authority is consulting on risk classification guidelines for medical devices.

The Health Sciences Authority provides standards resources for essential medical devices during COVID-19.

The Health Sciences Authority is consulting on guidance for medical device change notifications.

Proclaim™ XR 5 and XR 7 implantable pulse generators have late battery replacement notifications issued by Health Sciences Authority.

The Health Sciences Authority is consulting on guidance documents for medical devices.

Health Sciences Authority updates guidelines for SaMD risk classification and CDSS qualification.

The Health Sciences Authority is categorizing medical devices as IVD Test Kits for regulatory purposes.

The Health Sciences Authority launched an initiative to support the registration of unregistered medical devices.

The Health Sciences Authority has announced a recall of Aqualift™ Dermal Filler.

HSA received WHO recognition for its medical device regulatory systems and expands its role in biomedical economic development.

The IN.PACT® AMPHIRION PTA Balloon Catheter has been recalled by the Health Sciences Authority.

The Health Sciences Authority has issued an urgent recall for HeartWare® Ventricular Assist System batteries.

The Health Sciences Authority has classified certain medical devices as hearing aids.

HSA has granted SRA status for in vitro diagnostic medical devices in key regions.

Biomet 3i is voluntarily recalling OSSEOTITE dental implants due to safety concerns.