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2026 China NMPA Bluebook is here:
Here is the latest CFDA publication about Medical Device Classification Workflow For Overseas Companies: A. The application method Applicants can apply by visiting http://www.nifdc.org.cn/qxbgzx/CL0482/, clicking
For a long time, overseas drug and medical device companies have issues over China’s slow registration and approval process. This could result in delaying market
China is looking to speed up approvals for new drugs and devices and plans to accept data from clinical trials carried out overseas, a potential
China Brain Project to Focus on Brain Science and Research as Part of 13th Five-Year Plan Brain science has become a hot topic in global
Breaking news The signing ceremony for strategic cooperation between Shanghai CFDA and Pudong District government. Shanghai will be the first pilot to experiment medical device
IVD companies from worldwide are working hard to enter and expand in the fast-growing China and other Asian markets. This includes some novel approaches. We
A dozen branches and agencies of the Chinese central government have launched a cohesive effort to protect intellectual property (IP) of overseas companies and organizations.
A US-based medical artificial intelligence startup VoxelCloud has just a closed US$15 million in Series A round, led by Chinese Internet giant Tencent Holdings Ltd together
China Approves the Rega™ Line of Pacemakers CFDA said YES to the Rega™ line of pacemakers, China’s first domestically manufactured pacemakers that meet international standards.
CFDA has issued 7 new guidelines from September 13rd to September 21st. Even though they are called guidelines, once they are released, you are expected to
On September 11th, 2017, Beijing provincial CFDA announced a notice of “Strengthen the Supervision and Inspection of Import Medical Device Distributors”. 1. Objectives: · Understand
On September 18th, Beijing CFDA issued “Guideline for IVD Production Quality System Key Inspection Areas (Draft)” for comments. This guideline is the revised version for