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Browsing Tag
Central Drugs Standard Control Organisation
Ortho Clinical Diagnostics launches two COVID-19 antibody tests with 100 per cent specificity
The tests can identify with high accuracy previously infected patient who can donate antibody-containing plasma to treat severe…
Medical devices regulation in India
Rajat Prakash, Managing Partner, Athena Legal and Siddharth Mahajan, Partner, Athena Legal elaborate on the Medical Device Rules…
Medical Devices (Amendment) Rules 2020: Impact on new Government regulations
Rajdutt Shekhar Singh, Partner, Singh & Associates provides detailed insights into the Medical Devices Rules 2020 and how it…
Software as a medical device
Sameer Sah, Partner, and Maitreya Subramaniam, Associate, Khaitan & Co provide insights into the new notifications, the scope…
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Roche’s Accu-Chek brand compliant with revised standards of IS/ISO 15197:2013
As a result of the compliance, people will get confidence as there will be more accurate readings of blood glucose level Roche…
We see a shift towards increased regulation on devices
The regulatory scenario within medical device manufacturing environment in India is currently changing. Nikhilesh Tiwari, Founder…
Essential diagnostics list set to disrupt sector
It is ironical that though diagnostics influence about 70 per cent of healthcare decisions, WHO's first essential diagnostics list…
Medtronic insulin pumps flagged by CDSCO over cybersecurity concerns
The alert by Central Drugs Standard Control Organisation follows US FDA alert flagging these risks
QCO to raise cost without covering all aspects of patient safety: MtaI
Quality Control Orders has limited scope as it does not address all aspects of quality, safety, performance, only covers product…