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 can result in significant injury […]
Read MoreMDA 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 working days, MDA will remove […]
Read MoreMDA 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 the medical device registration certificate […]
Read MoreFDA 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 collagen type VII alpha 1 […]
Read MoreCosmetic 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 regulation are to control the […]
Read MoreFDA 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. DementiaDementia is a severe and […]
Read MoreMeasures are Taken To Enhance Healthcare.
China’s most recent policy or regulation initiatives to strengthen its national healthcare service system will facilitate the provision of high-quality healthcare services at the community level, assist in resolving issues that these regulation concern the public most in the sector, […]
Read MoreFDA Approval for OTC Hearing Aids
Hearing loss affects 30 million adults in the US, with a high number of people affected by it. Only one-fifth of those who could benefit from a hearing aid seek intervention. To increase access to hearing aids, the FDA Approval […]
Read MoreFDA Regulations Advance Decentralized Clinical Trials
The FDA Regulations is adopting further measures to facilitate the use of decentralized clinical trials (DCTs), in which part or all trial-related activities take place at places other than conventional clinical trial sites, including medicines, biologics, and devices. The government […]
Read MoreThe EU MDR Extended Transition Period is Acknowledged By The TGA Regulations
This article deals with the TGA regulations will acknowledges the prolonged transition period for the EU Medical Device Regulation. The EU extended the EU MDR transition period (external site for devices moving to the EU MDR) from May 26, 2024, […]
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