Australia - engelsk - Department of Health (Therapeutic Goods Administration)

integra neurosciences pty ltd -

Singapore - engelsk - HSA (Health Sciences Authority)

boston scientific asia pacific pte. ltd. - gastroenterology & urology - intended to be used to facilitate drainage from the kidney to the bladder via placement endoscopically, fluoroscopically or open surgical procedure by a trained physician.

Singapore - engelsk - HSA (Health Sciences Authority)

ascensia diabetes care singapore private limited - clinical chemistry - contour care blood glucose monitoring system is intended to be used for the measurement of blood glucose in both insulin and non-insulin treated patients with diabetes as an aid for patients and their health care professionals in monitoring the effectiveness of the patient’s diabetes control. it is intended for self-testing by persons with diabetes and health care professionals in venous blood and in fresh capillary whole blood drawn from the fingertip or palm. it should not be used for the diagnosis of or screening for diabetes or for neonatal use. alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). the contour care test strips are for use with the contour care blood glucose meter to quantitatively measure glucose in venous blood and fresh capillary whole blood drawn from the fingertips or palm. the system is intended for in vitro diagnostic use only.

Malaysia - engelsk - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

imeks pharma sdn. bhd. - amiodarone hydrochloride -