Asia
The Philippines Food and Drug Administration (FDA) has published a circular implementing the interim guidelines describing the conduct of licensing inspections for radiation facilities. In the case of any discrepancies, the provisions of the new circular shall...
Asia
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of medical devices, has announced the Unique Device Identification (UDI) system for medical devices to be introduced in the country. Regulatory Background and Current Situation...
Asia
Thailand Food and Drug Administration (FDA), the country’s regulating authority in the sphere of medical devices, has published several guidelines dedicated to certain important aspects related to the marketing of medical devices in Thailand. In particular, the new...
Asia
The Taiwan Food and Drug Administration (FDA) has published guidance dedicated to the state registration of the medical devices subject to reprocessing. The document describes the procedures related to premarket review, examination, and registration of single-use...
Asia
The Medical Device Authority (MDA), the department of the Ministry of Health Malaysia responsible for medical device regulations, has published guidance dedicated to the registration of conformity assessment bodies (CABs). The document consists of two parts: general...
Asia
Taiwan Food and Drugs Administration (FDA) has published draft guidance covering the regulations related to the special measures to be taken to ensure the safety of medical devices in the context of post-market surveillance. Together with the guidance on adverse event...
