China has a new medical device classification catalog: what you need to know

Grace Fu Palma, China Med Device The China Food and Drug Administration (CFDA) recently unveiled its new “Medical Device Classification Catalogue” – which has significant implications for medical devices registrations or renewals. The new catalog, announced Aug. 31 after a previous draft release and feedback period, goes into effect in less than a year – on Aug. 1, 2018.

China wants to dominate medtech: Here’s how

Under its “Made in China 2025” plan, the Chinese government seeks explosive growth in biomedical and high-end medical device manufacturing. Grace Fu Palma, China Med Device In 2015, the China State Council issued a 10-year manufacturing plan called “Made in China 2025.” The  goal is to elevate the “giant but weak” Chinese manufacturing industry into

China FDA issues draft guidance on clinical evaluation of some IVD reagents

Grace Fu Palma, China Med Device China FDA recently issued a draft guidance document on clinical evaluation basic requirements for clinical exempt IVD reagents, along with a second batch of clinical exempt class II IVD reagents – 130 reagents – to the agency’s directory. Key provisions in the draft, issued May 24, deal with the

Clinical evaluation reports and China: What you need to know

Grace Fu Palma, China Med Device China introduced new requirements for clinical evaluation reports in 2015. Understanding the China Food and Drug Administration’s new CER requirements can help companies to be better prepared in their CFDA submissions. 1. Summarizing data The CER must summarize the data from clinical literature, clinical experience, and clinical trials, etc.