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A Road Map To China's Medical Device Registration Process

A Road Map To China s Medical Device Registration Process
By May Ng and Ren Dazhi, ARQon
China has one of the most promising medical markets and its healthcare industry is currently the second largest in the world, following closely behind the U.S. From 2015 to 2019, the CAGR for the Chinese medical devices market has increased significantly, and it is expected to continue rising even more in the next four years due to the growing population, the escalating prevalence of diseases and disorders, and many other factors. Therefore, the Chinese medical device market is highly sought after.
Medical device approval is required to be obtained from the National Medical Products Administration (NMPA) (see ARQon’s website here for more information). The pre-market or product registration procedures are different for imported products and local domestic products. ....

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Roundup: 'On-the-spot' COVID-19 test receives CE Mark, Thriva launches women's hormones test and more briefs

DACADOO AND DIG ANNOUNCE PARTNERSHIP IN LIFESTYLE INSURANCE
Swiss health tech and insurtech company, dacadoo and Amsterdam-based Digital Insurance Group (DIG) are partnering up to expand their set of insurtech solutions for banking, insurance and brokers.
Using a new quote & buy products set to improve the underwriting process for life operators, the partnership aims to establish real-time pricing of life insurance in the major continents where both companies already have a presence in.
Ingo Weber, CEO & co-founder of DIG said: “Our mission is to give more people access to insurance and make sure they get the protection they need for themselves and their families. We work a lot with innovative insurers and enable them to build disruptive distribution and engagement models including ecosystems. With the solution we’re now building with dacadoo we can even increase the level of personalisation and customer experience.” ....

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EyeYon Medical Announces Innovative Medical Device Designation Granted For EndoArt In China

EyeYon Medical Announces Innovative Medical Device Designation Granted For EndoArt In China
TEL-AVIV, Israel, April 7, 2021 /PRNewswire/ EyeYon Medical, an Israeli start-up company developing a variety of ophthalmic products for vision-threatening conditions, announces today that EndoArt was granted the Innovative Device Status by China s Center for Medical Device Evaluation, the arm of the National Medical Products Administration (NMPA). Following the announcement, the EndoArt became the only ophthalmic device in the world to receive both China s Innovative Device Status and the Breakthrough Device Designation from the U.S. Food and Drug Administration.
The EndoArt is the world s first synthetic implant that enables doctors to treat chronic corneal edema, the main reason for the world s most common organ transplant, with a minimally invasive surgery that erodes the use of human tissue.The EndoArt is designed to replace dysfunctional endothelium in patients awaiting huma ....

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Medtronic Announces First Procedures in Pivotal Trial to Evaluate Novel Ablation Technology in Treating Atrial Fibrillation

Medtronic Announces First Procedures in Pivotal Trial to Evaluate Novel Ablation Technology in Treating Atrial Fibrillation
Study Will Determine the Safety and Effectiveness of Pulsed Electrical Fields to Interrupt Irregular Heart Rhythms Medtronic plc the global leader in medical technology, today announced the first procedures in the investigational device exemption pivotal trial to evaluate the PulseSelect ™ Pulsed Field Ablation System, a novel, breakthrough technology that uses pulsed electric fields to treat atrial fibrillation . …
Study Will Determine the Safety and Effectiveness of Pulsed Electrical Fields to Interrupt Irregular Heart Rhythms
Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced the first procedures in the investigational device exemption (IDE) pivotal trial to evaluate the PulseSelect ™ Pulsed Field Ablation (PFA) System, a novel, breakthrough technology that uses pulsed electric fields to treat atrial fib ....

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