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The MFDS has released guidance surrounding the topics of imported devices and scarce/urgently needed medical devices.
#RegDesk#MFDS#Guidancehttps://hubs.ly/H0mQ2Cv0 -
The MHRA has released guidance regarding notified bodies and grace periods.
#RegDesk#MHRA#MedicalDeviceshttps://hubs.ly/H0mSg120 -
The EC announced that three more notified bodies are awaiting publication in the Nando database as designated under the MDR.
#RegDesk#MDR#EC#NotifiedBodieshttps://hubs.ly/H0mJhgd0 -
Philippines FDA has announced the implementation of a new regulatory framework for medical devices.
#RegDesk#Philippines#MedicalDeviceshttps://hubs.ly/H0mSnJs0 -
Australia's TGA has issued a consultation paper dedicated to the fees and charges associated with medical device registration.
#RegDesk#TGA#MedicalDeviceshttps://hubs.ly/H0mHlgK0 -
New
Customer Review on Regulatory and Clinical Writing
Visit : https://bit.ly/2LhScrJ
#Regulatory#Pharma#MedicalDevice#Biotech#FDA#Health#clinicalwriting#LifeSciences#RAQA#MedTech#RegDesk#MDCG#RegulatoryNewspic.twitter.com/8SfcjwS0Gv
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The FDA has published guidance dedicated to 510(k) premarket notification submissions related to computer-assisted detection devices applied to radiology images and radiology device data.
#RegDesk#FDA#CADe https://hubs.ly/H0mJtHw0 -
The IMDRF has released new clinical guidelines regarding clinical evaluations, investigations, and evidence. https://ecs.page.link/KUjWv
#RegDesk#IMDRF#MedicalDevices#Regulatory#Pharma#MedicalDevice#Biotech#FDA#Health#clinicalwriting#LifeSciences -
Genus Lifesciences has sued the FDA because they believe the agency has acted unlawfully in allowing a competitor to bring certain products to market.
#RegDesk#FDA#MedicalDeviceshttps://hubs.ly/H0mPPyG0 -
The FDA has launched their PEPFAR drug database, used for various antiretroviral HIV drugs available to purchase through the President’s Emergency Plan for AIDS Relief (PEPFAR).
#RegDesk#FDA#PEPFARhttps://hubs.ly/H0mQQRj0 -
The MHRA has released guidance on clinical investigations in order to assist manufacturers in complying with any and all applicable requirements.
#RegDesk#MHRA#ClinicalInvestigationshttps://hubs.ly/H0mNY5f0 -
The FDA has released a statement explaining their development process to combat Coronavirus.
#RegDesk#FDA#Coronavirushttps://hubs.ly/H0mNHSL0 -
The FDA has released guidance surrounding premarket notification submissions for arthroscopy pump tubing sets.
#RegDesk#FDA#Guidancehttps://hubs.ly/H0mMD8f0 -
In 2019, Montenegro adopted the Law on Medical Devices. This established general principles related to manufacturing, distributing and supervising medical devices on the domestic market.
#RegDesk#MedicalDevices#Montenegrohttps://hubs.ly/H0mLXCv0 -
The SFDA has released guidance surrounding innovative devices and recognized standards for medical devices.
#RegDesk#SFDA#MedicalDeviceshttps://hubs.ly/H0mLJ7f0 -
The FDA warns that several types of GE Healthcare devices could be hacked into to silence alarms, generate false alarms and interfere with alarms of patient monitors.
#RegDesk#FDA#CyberSecurityhttps://hubs.ly/H0mLy5z0
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