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No major report of discordant results reported by Covid testing labs: Govt

Till now no major report of discordant test results has been reported by COVID-19 testing laboratories, Minister of State for Health Ashwini Choubey told Rajya Sabha on Monday. He was responding to a question on whether capping the price of COVID-19 tests has forced several labs to use relatively inexpensive kits raising the risk of false negative and compromising data. Keeping in view fast tracking of approval of test kits, increasing indigenous manufacturing, inclusion of alternative platforms like CBNAAT and GeneXperts, improved market availability at competitive prices, the Union health ministry has advised state governments and union territory (UT) administrations to negotiate with private labs and fix mutually agreeable prices for COVID-19 testing, Choubey said.

Regulation For Rigorous Clinical Investigation Of Medical Devices: The Missing Link Of The Atma-nirbhar Drive In Healthcare - Food, Drugs, Healthcare, Life Sciences

Regulation For Rigorous Clinical Investigation Of Medical Devices: The Missing Link Of The Atma-nirbhar Drive In Healthcare - Food, Drugs, Healthcare, Life Sciences
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India 2020 Pharmaceutical Industry Developments & Regulations

Monday, January 11, 2021 INTRODUCTION The pharmaceutical and life sciences industry has been at the center of public discussion this year like never before due to the COVID-19 pandemic. The role of the industry has been crucial not only in developing potential treatments or vaccines for COVID-19 but also in ensuring that drug supplies for other disorders remain uninterrupted. The drug regulator has also acted quickly and decisively during this pandemic to ensure that pharmaceutical companies get the support they need to be able to maintain a steady supply of medicines. In this pharma wrap, we have summarized the key regulatory developments that took place over 2020.

Regulatory Yearly Wrap 2020: Medical Devices in India

Tuesday, January 12, 2021 This year has been perhaps the most significant year for medical device companies from a regulation perspective since the Medical Device Rules, 2017 (explained below) came into force on January 01, 2018. The Government has amended medical device regulation to significantly expand the reach of medical device regulation. There is also some discussion on enacting a new legislation altogether specifically for medical devices (medical devices are currently regulated as drugs). The sector has also been largely unaffected by the COVID-19 pandemic and the regulator provided for relaxations in regulatory compliances as required. In this wrap, we have covered some of the significant developments in the medical device space this year and what we hope to see ahead in 2021.

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