China Starts Clampdown on Unregistered Devices, Threatens Severe Punishments

China – China Starts Clampdown on Unregistered Devices, Threatens Severe Punishments

China has begun an eight-month drive to stop the use and sale of unregistered medical devices. The first stage of the crackdown will require...
Japanese regulators extend participation in Medical Device Single Audit Program (MDSAP)

Japan – Japanese regulators extend participation in Medical Device Single Audit Program (MDSAP)

Japanese regulators extending participation in MDSAP through early 2020; PMDA will continue recognizing MDSAP certificates for QMS compliance through the next year. The Japanese...
An Action Plan for Medical Devices

Australia – An Action Plan for Medical Devices

On 4 April 2019, the 'Action Plan for Medical Devices' was released. Whilst the regulatory requirements in Australia are some of the most stringent in...
Japanese regulators increase medical device registration fees for 2019

Japan – Japanese regulators increase medical device registration fees for 2019

Japan’s PMDA has increased medical device registration fees as of Aprill 1, 2019. Any Japanese market registration received after March 29, 2019 will...
China Starts Clampdown on Unregistered Devices, Threatens Severe Punishments

China – Hong Kong Proposes Overhaul of Guidance on Medical Device Responsible Persons

The Hong Kong Medical Device Control Office (MDCO) is preparing to overhaul its guidance on the listing of local responsible persons (LRPs) for new...
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 Posts Guide to Revised Rules on New Drugs and Clinical Trials

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...
TGA Overhauls Guidance on Risk Management Plans for Medicines and Biologicals

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...

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