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2025 China NMPA Bluebook is here:
One giant leap from China medical device regulators—the NMPA began to recognize self-test report from manufacturers, with detailed guidebook on how to self-test. After two drafts, the NMPA finalized document
The NMPA Standards Management Center published the “First Batch of Combination Products Classification Results in 2021” on July 7. Worth noted that overseas manufacturers pay more attention to the combination
An amendment of the Regulation on the Supervision and Administration of Medical Devices was adopted by the China State Council on December 22, 2020. On March 16, 2021 the amendment
On January 25, 2021 the China National Health Commission issued the Technical Guideline for COVID-19 Prevention and Control on Manufacturers and Suppliers of Imported Products. Mentioned in the guidelines, “the
Before July 21, 2021 the devices and drugs from Hongkong and Macao public hospitals can be clinically used in a Shenzhen Hospital, according to a joint announcement by Guangdong NMPA
Grace Palma, CEO of China Med Device, is invited to talk on Precision Medicine Panel of CABA (Chinese-American BioMedical Association) meeting in Boston. Grace will focus on IVD/CDx regulatory and clinical
NORTH ANDOVER, Mass. – January 31, 2019 – ChinaMed Device, LLC (CMD), a leader in helping medtech/IVD companies with RA, QA and CRO in China, has successfully helped United Imaging
On Dec 18, ChinaMed Device, LLC is interviewed by Bloomberg on European effects of U.S-China Trade War. Other interviewees include Goldman Sachs, BS Global Wealth Management, and European Union Chamber
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 Paradigm Spine, a leader in
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 joints replacement, and other organ
NORTH ANDOVER, Mass. – July 27, 2018 – China Med Device, LLC (CMD), a leader in helping medical technology companies enter the Chinese marketplace, received the contract to guide China
Disease Risk Management A hot application scenario of medical artificial intelligence is disease risk management. When applies to a specific disease treatment area, AI can improve the diagnosis accuracy and
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