CFDA Updates

November 8, 2018

NMPA(CFDA) Suggests Improving Definition Process and Transparency of Combination Products

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 […]
November 6, 2018

CFDA Monthly Roundup (October)

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), […]
November 1, 2018

CFDA: 27 Medical Device Guidelines Released in One Day

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 […]
October 29, 2018

Rare Disease Device Guideline: Imported Device Exempt from Clinical Trial If Meeting Certain Requirements

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

CFDA Monthly Roundup (September)

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), […]