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SCHEER – Updated Guidelines on Phthalates in Medical Devices

The Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) has been asked by the European Commission (EC) or EU Regulation to update the recommendations for weighing the benefits and risks of the presence of […]

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MDA Regulations on Third Edition Guidance Document on Medical Face Masks and Respirators

The Medical Device Authority (MDA) regulations created this guidance document to aid the healthcare community and the industry in adhering to the Medical Device Act’s (Act 737) laws and requirements. The new recommendation updates the […]

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FDA Recalls Draeger Medical’s Seattle PAP Plus and Breathing Circuit/Anesthesia Kits

This article deals with FDA device approval which Recalls Draeger Medical’s Seattle PAP Plus and Breathing Circuit/Anesthesia Kits due to the risk of loose or detached components restricting breathing support. The use of these devices […]

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MDA will Withdraw the Medical Device Registration and Change Notification Application

This article deals with the change of notification application and withdrawal of medical device registration by MDA. If the medical device registration (new and re-registered) application and change notification application is not completed within 30 […]

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MDA Implementing the Electronic Medical Device Registration Certificate

The Medical Device Authority MDA will start using electronic medical device registration certificates starting on May 2, 2023.  Once the application is complete (complete status) and the registration money is paid, the establishment can get […]

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FDA Approval For Wound Treatment in Epidermolysis Bullosa

Vyjuvek, a herpes simplex virus type 1 (HSV-1) vector-based gene therapy, has been given approval by the FDA for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the […]

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Cosmetic Medicine Are Now Under Stricter Regulation

A guideline to strengthen oversight of the medical cosmetology industry was recently released by eleven central departments, including the State Administration for Market Regulation, the National Health Commission, and the Ministry of Public Security. The […]

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FDA Approved for Drug To Treat Alzheimer’s Agitation Symptoms with Dementia

The FDA approved Rexulti (brexpiprazole) oral tablets are supplementary approval for the treatment of agitation associated with dementia caused by Alzheimer’s disease. This is the first therapy option for this indication that has FDA Approved. […]

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