Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
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
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
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
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
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
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
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
Monthly NMPA (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
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
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
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
For the first time in 2018, NMPA (formerly CFDA) issued clinical trial incompliant companies report. In this Medical Device Clinical Audit Notice on September 12th,