Singapore Issues Guidance on Registering IVD Devices

January 8, 2009
Singapore’s Health Sciences Authority has released a draft guidance on preparing a product registration for in vitro diagnostic (IVD) devices using the common submission dossier template (CSDT) adopted by the Association of Southeast Asian Nations. The guidance provides detail on information to include in the device description and the preclinical and clinical evidence sections of the CSDT.
International Medical Device Regulatory Monitor