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2025 China NMPA Bluebook is here:
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 launch in China of their
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 huge benefit for both international
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 scientific research in recent years.
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 registrant system. Medical device registrant
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 have seen product development, market
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. This campaign is being participated
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 with named US investors including
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. This product is manufactured in
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 comply with them whether your
On September 11th, 2017, Beijing provincial CFDA announced a notice of “Strengthen the Supervision and Inspection of Import Medical Device Distributors”. 1. Objectives: · Understand the operation quality control status
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 “Guideline for IVD Production Quality
Shandong Weigao Group from China filed to pay US$850 million for Argon Medical Devices, to expand its product line in China as well as expanding its growth outside the country.
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