With the development of the medical technology, the NMPA(CFDA) started to strengthen the management of the combination products. In 2018, CFDA held a symposium on “Preliminary attribute definition and evaluation […]
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), […]
CFDA issued 27 device guidelines on Oct.8th, covering benefit-risk assessment, cardiovascular, urology and orthopedic devices and immune oncology IVDs, etc. Whether you are renewing or doing new registration, your medical […]
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 […]
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), […]