TGA suspends overseas GMP inspections and QMS audits until further notice

Australia – TGA suspends overseas GMP inspections and QMS audits until further notice

Consistent with the Australian Government's latest travel restrictions, the Therapeutic Goods Administration (TGA) has suspended all overseas GMP (Good Manufacturing Practice) inspections and QMS (Quality...
Hong Kong regulator will continue to recognize South Korean approvals

China – Hong Kong regulator will continue to recognize South Korean approvals

Hong Kong’s Medical Device Division (MDD), formerly the Medical Device Control Office (MDCO), announced an extension of its trial program leveraging marketing approvals from the Ministry...
COVID-19 outbreak triggers regulatory interventions in Asia-Pacific region

Asia-Pacific – COVID-19 outbreak triggers regulatory interventions in Asia-Pacific region

The alarming worldwide diffusion of COVID-19, also known as novel coronavirus, has inspired numerous governments to intervene to counter the spread of the disease....
TGA suspends overseas GMP inspections and QMS audits until further notice

Australia – Update on reclassification of a number of medical devices

The TGA thanks respondents who provided submissions in response to the consultations published in early 2019, relating to the proposed reclassification of a number...
Singapore HSA revises guidance and technical documents

Singapore – Singapore HSA revises guidance and technical documents

On February 17, Singapore’s Health Sciences Authority (HSA) published a number of revised guidance and technical reference documents. Version and cybersecurity requirements for software registration The...
Hong Kong regulator will continue to recognize South Korean approvals

China – China CMDE publishes guidance on generic medical device names

China’s Center for Medical Device Evaluation (CMDE) published Announcement No. 99 of 2019, a guidance document intended to clarify the principles employed by the National...
TGA suspends overseas GMP inspections and QMS audits until further notice

Australia – Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed...

Technology changes have the potential to deliver significant benefits and opportunities to Australians. Recent advances are both disrupting and changing the health sector, where...
India Commits to Phased Overhaul of Medical Device Regulations

India – India Commits to Phased Overhaul of Medical Device Regulations

The Indian government has set out the timeline for moving to a new regulatory system for medical devices. Officials intend to institute a law...
Seegene's COVID-19 test authorized for emergency use in Korea

South Korea – Seegene’s COVID-19 test authorized for emergency use in Korea

Korea Centers for Disease Control & Prevention notified Seegene Inc. (096530.KQ) that Korea Ministry of Food and Drug Safety (MFDS; Former KFDA) approved its...
TGA suspends overseas GMP inspections and QMS audits until further notice

Australia – Review of Medicines and Medical Devices Regulation (MMDR)

Australia's regulatory framework for therapeutic goods is undergoing a number of changes in response to the Review of Medicines and Medical Devices Regulation (MMDR). The Government accepted...