Singapore HSA revises guidance and technical documents

Singapore – Singapore issues new guidance for software as a medical device

As software has begun to have an increasingly important role in many medical devices that rely on it for safe and effective function, Singapore’s...
Singapore HSA revises guidance and technical documents

Singapore – Singapore adds HIBCC to list of UDI issuing agents

Singapore’s medical device market regulator, the Health Sciences Authority (HSA), has announced that a new designated issuing agency (IA) has been added to its...
Seegene's COVID-19 test authorized for emergency use in Korea

South Korea – South Korea rules on emergency production and distribution of medical products

Regulators in South Korea have introduced policies and procedures ordering the production and distribution of medical products during a public health emergency (PHE). The Ministry...

Australia – Update: TGA defines which digital mental health software it regulates

Australia’s medical device market regulator has issued new guidance on digital mental health device regulation. The Therapeutic Goods Administration (TGA) published the fact sheet to inform...
Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

Japan – Japan updates guidance on QMS Conformity Survey applications

Japan’s Ministry of Health, Labour and Welfare (MHLW) has updated its guidance on documents that medical device market registrants must submit when applying for...
TGA Updates Guidance on the Testing of Biological Medicines

Australia – TGA set to accept medical device assessments from Singapore’s HSA

The Therapeutic Goods Administration (TGA), Australia’s medical device market regulator, has announced that it now recognizes Singapore’s Health Sciences Authority (HSA) as a comparable...

India – India’s medical device regulators adopt amendment regarding cancellation and suspension of licenses

If you are a medical device manufacturer or supplier you will want to make sure to comply with the latest rules in order to...
Seegene's COVID-19 test authorized for emergency use in Korea

South Korea – MFDS rules on medical device insurance and designated non-clinical testing institutions

South Korea’s Ministry of Food and Drug Safety (MFDS) has announced updates to several medical device and in vitro diagnostic (IVD) regulations. The announcements include: ...
Process chart: Medical device & IVD registration requirements in Malaysia

Malaysia – MDA publishes draft guidance on notification of custom-made medical devices

The Malaysian Medical Device Authority (MDA) has published draft guidance that provides requirements and a notification process for manufacturers to follow for custom products...

Australia – Process chart: Australia TGA regulatory approval for medical devices

Australia’s medical device market regulator has issued new guidance on digital mental health device regulation. The Therapeutic Goods Administration (TGA) published the fact sheet to inform...

NOS PROCHAINES FORMATIONS