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.
The 15th International Show for Products, Equipment and Services for the Healthcare Sector(Expo Medical) will be held at Centro Costa Salguero, Buenos Aires, Argentina from September 27 to September 29, 2017. As the leading global pharmaceutical and medical device B2B online platform, Ddu is going to attend the exhibition along with the products of high priority members and commits itself to the development of the South American medical trade market.
The 13th Health Asia & Pharma Asia International Exhibition & Conferences (Pharma Asia) will be held at the Karachi Expo Center from August 22nd to August 24th 2017. As the leading global pharmaceutical and medical device B2B online platform, Ddu is going to attend the exhibition along with the products of high priority members.
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