Seegene's COVID-19 test authorized for emergency use in Korea

South Korea – South Korea adds renewal requirement for new medical device authorizations

MFDS issues significant revision to Medical Devices Act South Korea’s Ministry of Food and Drug Safety (MFDS) published a revision to Article 49 of the...
TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires

Australia – Post-market evaluation of serology-based point of care tests

In response to the COVID-19 pandemic, the Therapeutic Goods Administration (TGA) has expedited the approval (with conditions) of COVID-19 tests including tests intended for...
TGA suspends overseas GMP inspections and QMS audits until further notice

Australia – Australia’s TGA publishes new guidances and consultation results

Our most recent reports on regulatory news in Australia have focused on responses to the COVID-19 pandemic, but manufacturers with an interest in this...
Hong Kong regulator will continue to recognize South Korean approvals

China – Chinese government bodies introduce further COVID-19 responses

In early March, we reported on emergency measures being employed in various Asia-Pacific countries, including China, to combat the COVID-19 pandemic. Since that time, some noteworthy...
TGA suspends overseas GMP inspections and QMS audits until further notice

Australia – Post-market review of face masks

COVID-19 has increased the demand and supply of personal protective equipment (PPE) such as face masks and respirators, gloves, face shields, goggles, and gowns...
TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires

Australia – Medical device labelling obligations

This information explains the labelling requirements for medical devices to help manufacturers and sponsors meet their obligations. Labelling refers to labels and other information...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – India’s CDSCO responds to COVID-19 with new approval, import, and safety measures

India’s Central Drugs Standard Control Organisation (CDSCO) has published several notices since mid-March in response to the ongoing pandemic. These address new measures to...
TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires

Australia – Manufacturing medical devices for COVID-19 including 3-D printing

As a result of the COVID-19 pandemic, the Therapeutic Goods Administration (TGA) is receiving an increased number of enquiries from people seeking to develop...
Hong Kong regulator will continue to recognize South Korean approvals

China – NMPA Seeks to Ensure Quality of Exports as China Becomes Key Supplier...

China is stepping up efforts to ensure the safety and quality of exported medical devices. The actions come as countries around the world look...
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...

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