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October 29, 2018
CFDA issued Registration Guideline on Medical Device for Rare Disease on October 18th, 2018 in an effort to address the huge unmet medical needs. The guideline lists three situations when […]
October 26, 2018
Monthly CFDA News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com), […]
October 24, 2018
The Ministry of Science and Technology of China imposed penalties today (Oct 24th) on 6 companies for violating regulations on human genetic resources. AstraZeneca and 5 domestic companies are on […]
October 16, 2018
Wednesday, 24 October 2018 3:00-7:00 pm EST The Conference Center at Waltham Woods 860 Winter Street Waltham, MA 02451 Don’t miss this unique opportunity to engage with regulatory and […]
October 16, 2018
In the month of September, unprecedented number of medical device guidelines and industry standards issued by CFDA to expedite your registration and renewal. Guideline CFDA issued 12 Technical Review […]