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Pharma firms with approval for projects under PLI scheme should start production at the earliest: Gowda
expresspharma
April 22, 2021
This will enable India to provide pharma and medical devices products to domestic and global markets at competitive rates.
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Govt announces guidelines to set up parks for bulk drugs and med devices
expresspharma
July 28, 2020
The government has opted for challenges mode to ensure the most attractive investment regime.
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Spartan’s COVID-19 test recall exposes issues of rapid medical device approval, says report
europeanpharmaceuticalreview
May 18, 2020
Following the recall of Spartan Bioscience’s COVID-19 test by Health Canada, a report suggests this demonstrates the challenges associated with rapid approval.
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Industry players applaud govt’s move to boost manufacturing of APIs, med devices
expresspharma
March 24, 2020
The approved scheme will promote bulk drug parks for financing common infrastructure facilities in three bulk drug parks with a financial investment of Rs 3,000 crore in the next five years, the IPA said.
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Haselmeier Receives Medical Device Master File Number for D-Flex Product Platform
b3cnewswire
March 17, 2020
Haselmeier officially announces that it has received Master File Number MAF3202 from the Food and Drug Administration (FDA) of the United States for its D-Flex product platform, a new generation of injection pen systems for subcutaneous self-administratio
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NMPA Issued the Notice on Expanding the Pilot of the Medical Device Registrant System
chinadaily
August 21, 2019
As per the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of Review & Approval System to Encourage Innovation in ...
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Provisions for Medical Device Registration
chinadaily
July 26, 2019
The Provisions is formulated in accordance with the Regulations on Supervision and Administration of Medical Devices, with a view to standardizing the administration of medical device registration and ...
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New guidance issued for 3D-printed Medical Device License applicants
europeanpharmaceuticalreview
May 15, 2019
Health Canada has published new guidance for manufacturers of higher-risk 3D-printed medical devices.
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FDA permits marketing of first medical device for treatment of ADHD
worldpharmanews
April 24, 2019
The U.S. Food and Drug Administration (FDA) permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD).
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ECRI Institute opens international medical device evaluation centre
biospectrumasia
April 03, 2019
The independent lab, located in Selangor, Malaysia, will evaluate medical devices used across all care settings in Europe and Asia.