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2026 China NMPA Bluebook is here:
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 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
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
Thanks for taking the time to visit China Med Device at the RAPS Convergence in Vancouver. I appreciate the opportunity to share some of the
The price of high-value medical consumables is relatively high. These consumables are usually used for special treatments like cardiac intervention therapy, peripheral vascular intervention, artificial
We are pleased to announce Grace Fu Palma, CEO of China Med Device, LLC, was selected to chair the opening panel of China Regulatory and
Monthly NMPA (CFDA) News Roundup (August) Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and
Monthly CFDA News Roundup (August) Monthly CFDA News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in
Biological testing points 1. Preparation of testing materials Technical requirements, specifications are equivalent to performance testing. The contracts may be different, it needs to be
China’s guideline requires that the Class III medical device registration must submit a test report, and the test report should be issued by a certified