India Seeks Feedback on Mandatory use of QR Codes on API Packaging

India – Indian regulators add to list of medical device testing laboratories

Indian regulators have updated their list of organizations qualifying as Medical Device Testing Laboratories (MDTLs), adding three entities to perform testing and evaluation of...

Australia – Australia unveils updated clinical evidence guidelines for medical devices and new private...

The Australian Therapeutic Goods Administration (TGA) updated several regulations, including medical devices and in vitro diagnostic (IVD) devices under Australian legislation. Changes involve clinical...
Seegene's COVID-19 test authorized for emergency use in Korea

South Korea – Updates: Innovative device designations, IVD Act enforcement

Regulators in South Korea have issued two recent revisions to medical device and in vitro diagnostic (IVD) registration and approval requirements of note for...
Home-grown colorectal cancer drug approved in China

China – NMPA rules on medical device naming, QMS inspections and industry standards

China’s National Medical Products Administration (NMPA) published a number of guidance documents pertaining to medical devices and IVD regulations, including medical device naming guidelines,...

Australia – Update: Medical device UDI implementation, Essential Principles guidance

The Therapeutic Goods Administration (TGA), Australia’s medical device market regulatory entity, has issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles compliance...

Australia – Australia updates guidance on implantable medical devices, required six-monthly report

Australia’s Therapeutic Goods Administration has issued a number of new pieces of guidance that medical device manufacturers doing business in the country should review...
Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

Japan – Japan’s MHLW updates medical device program display code and labeling laws

Japan’s medical device regulators have updated regulations and implementation guidelines for enforcement of the PMD Act and bar code labeling laws. Manufacturers should become...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – India issues new draft IVD rules and updated classifications for rehab devices

Indian medical device market regulators have published new draft in vitro diagnostic device rules and made them available for industry comment. In addition, Indian...
Singapore HSA revises guidance and technical documents

Singapore – HSA to commence Phase I implementation of UDI labeling in November 2022

Singapore’s medical device market regulator, the Health Services Authority (HSA), has issued a notification indicating that Phase I implementation of its Unique Device Identification...
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...

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