November 30, 2018

More IVD Clinical Trials to Receive NMPA (CFDA) Clinical Audit

The compliance with the NMPA (CFDA) clinical trial requirements in China is getting more strictly audited and reinforced.  On November 13th, NMPA (CFDA) issued the 2nd notification in 2018 for […]
November 26, 2018

NMPA (CFDA) New IVD Clinical Guideline: 11 Requirements You Should be Prepared for!

NMPA (CFDA) published draft IVD Clinical Trial Guideline for feedback on November 22nd, 2018 during the U.S. Thanksgiving holiday. After initial clinical guideline issued in September 2014, NMPA (CFDA) has […]
November 9, 2018

Our Client, RTI Surgical®, to Acquire Paradigm Spine

Congratulate our client and long-term partner, RTI Surgical, on acquiring Paradigm Spine! RTI Surgical, a global surgical implant company, has signed an agreement to acquire Paradigm Spine, a leader in […]
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 (, […]
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 […]