July 23, 2017
July 23, 2017
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Rapid Medical, an Israeli company focused on the development of neurovascular interventional devices, has completed a US$9 million series B financing to advance the commercialization of the company’s minimally invasive […]
July 22, 2017
July 22, 2017
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In this year, there are signs that China is the close second to US and is getting head in some of the key AI areas. AI is now widely considered […]
July 20, 2017
July 20, 2017
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China has recently surpassed Japan as the second largest market for orthopedic medical devices in the world. With an aging population and improvement in health insurance policies, the demand for […]
July 20, 2017
July 20, 2017
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CFDA has issued 4 new guidelines from June 29rd to July 4th. Two of them are for IVD registration and the other two is for medical device. Even though they are called guidelines, once they are released, you are expected to comply with them whether your products are in the review or new submission phase. Find out how these guidelines impact your devices in China, please contact us at info@ChinaMedDevice.com.
- The registration technical review guideline for Helicobacter Pylori (HP) Antigen / Antibody Testing Reagent for comments.
- The technical review guideline on HCV Genotyping Testing Reagent for comments.
- The clinical evaluation technical review guideline on Endometrial Removal Equipment for comments.
- Clinical evaluation technical review guideline on Proton/carbon Ion Treatment System
July 20, 2017
July 20, 2017
Categories
As part of its effort to ensure the quality of data in medical device filings, CFDA has published documents to overhaul the regulation of how medical devices are developed and […]