Australian medical device regulators preparing Brexit contingency plans

Australia – Australian medical device regulators preparing Brexit contingency plans

The Australian TGA has drawn up plans to blunt the impact of Brexit on the country’s medical device market. TGA will continue recognizing...
TGA Proposes 5 Medical Device Classifications in Line With EU MDR

Australia – TGA Proposes 5 Medical Device Classifications in Line With EU MDR

In five separate consultations opened on Wednesday, Australia’s Therapeutic Goods Administration (TGA) proposed new medical device classifications in line with the EU medical device...
Healthcare needs a unified regulator for drugs and devices, advise experts

India – Healthcare needs a unified regulator for drugs and devices, advise experts

The $34 billion Indian pharma sector is seeking a unified healthcare regulator that addresses multiple stakeholders’ needs, in an effort to cut through bureaucratic...
India Advances Plan to Create Mobile Drug Testing Laboratories

India – India to Treat Implants and Imaging Equipment as Drugs From April 2020

India is pushing ahead with previously discussed plans to categorize certain classes of medical device as drugs. The change will mean implants and imaging...
Australian manufacturing licences and overseas GMP certification

Australia – Australia Proposes to Reclassify Spinal Implants in Line With EU MDR

Australia’s Therapeutic Goods Administration (TGA) opened a consultation on Monday to obtain feedback on its proposal to reclassify all spinal implantable medical devices to...
Hong Kong Medical Device Regulatory Update: IVD listings, acceptance period for NMPA approvals

China – Hong Kong Medical Device Regulatory Update: IVD listings, acceptance period for NMPA...

Hong Kong MDCO to allow listing of IVD devices in Medical Device Administrative Control System (MCAS) starting in February 2019. MDCO’s trial program...
China Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal

China – NMPA Releases Draft Good Manufacturing Practice Appendix on Standalone Software

On January 3, 2019, the National Medical Products Administration (“NMPA”) published a draft standalone software appendix of medical device good manufacturing practice (“Draft Standalone...
India's health ministry accepts eIFU for medical devices

India – India’s health ministry accepts eIFU for medical devices

MTaI represents leading research-based medical tech companies that have significant investments in India. The association said the eIFU acceptance is in is line with...
China’s NMPA Launches Voluntary Device Master File Process

China – China’s NMPA Launches Voluntary Device Master File Process

Chinese regulators are launching a record filing process for medical device master files (DMFs). DMFs are used by NMPA reviewers and Chinese market...
Australian manufacturing licences and overseas GMP certification

Australia – Australia Explores Adopting UDI System

Device companies were given a tight deadline on Monday to comment on a new proposal that would establish a unique device identification (UDI) system...

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