Major market opportunities are emerging in the Asia-Pacific region for medical devices, with countries like China, Hong Kong, and Singapore establishing regulatory frameworks. This evolving landscape ...
Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical ...
If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare ...
“We’re proud to welcome CMC Medical Devices to the Registrar Corp family,” said Raj Shah, CEO of Registrar Corp. “Together, we offer medical device manufacturers a single partner to navigate complex ...
Regulatory overhaul aims to cut compliance burdens, improve safety, and attract investment in India’s $15B medical devices ...
Medical device labeling is considered as important as classifying a product or creating an insulation diagram. In IEC 60601-1, labeling is deemed "a critical component of a medical device." 1 The ...
Refurbished Medical Device Imports Threaten Patient Safety, Indigenous Manufacturing, Warns Industry
As India pushes to strengthen its domestic medical device ecosystem, industry stakeholders have cautioned that the import of ...
The Health Insurance Portability and Accountability Act (HIPAA) regulations have been widely discussed in the press and within the medical provider community. Doctors and hospitals have grown used to ...
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Medical Device Validation Solutions for Evolving Industry Needs, Upcoming Webinar Hosted by Xtalks
In this free webinar, learn how medical devices benefit from modern digital validation strategies. Attendees will learn how digital validation builds confidence and removes redundancy. The featured ...
A Delhi High Court plea seeks tax relief by reclassifying air purifiers—but doctors and device experts aren't convinced.
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