Computer software used in healthcare device applications developed for demographic data gathering, physical examinations or therapies are increasingly part of the regulatory landscape. This article, ...

We missed this earlier: On October 21, the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare (MoHFW), released draft guidelines for granting licences ...

The Central Drugs Standard Control Organisation (CDSCO) has issued a draft guidance document on medical device software to bring more clarity on the regulatory aspects of their usage. The document, ...

New Delhi: In a move to align India’s regulatory framework for medical device software with global standards, the Central Drugs Standard Control Organization (CDSCO) has released new draft guidelines ...

The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both ...

In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be posting a series ...

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is warning device manufacturers that new regulations for software-based medical devices may have changed the classification of ...

There’s currently a lot of buzz around regulations for digital health, particularly in Europe with the EU Medical Device Regulations (MDR) which went into effect May 26 after a one year delay due to ...

“Classification isn’t an administrative detail; it’s the foundation of patient safety,” he says. “If a platform is being used to support clinical decision-making, issue alerts or guide escalation, ...