Over the past decade, the medical device industry has seen a boom in development and innovative ideas. With this innovation came a rise in the costs of medical device products which presents new challenges to buyers. With this in mind, we have compiled a list of 4 tips that could help you in this decision making process.
Virtual Incision’s RASD weighs just two pounds and is designed to perform the procedure through a smaller incision, potentially reducing recovery time and mitigating the risk of surgical complications.
The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on September 6. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations for this elaborate device field.
The Draft Amendment to Order 650 published by CFDA last month brings some good news around the streamlined reviews of medical device submissions in China and especially for manufacturers of Innovative Devices. Not only will manufacturers of innovative medical devices be exempted from providing proof of sales abroad to CFDA, the mandatory local type testing requirements are also abolished. Nevertheless, there still exist some challenges for the unwary.
The U.S. Food and Drug Administration(FDA) today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens' power after cataract surgery so that the patient will have better vision when not using glasses.
To promote the adjustment of industrial structure and technological innovation in the drug and medical device sector, the Communist Party of China’s Central Committee and the State Council jointly released a guideline on the reform of the review and approval system, which came into effect on October 8, 2017.
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