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FARAWAVE Pulsed Field Ablation Catheter and FARASTAR Pulsed Field Ablation Generator System Approved for Marketing
2025-02-19
Recently, the innovative products FARAWAVE Pulsed Field Ablation Catheter and FARASTAR Pulsed Field Ablation Generator System of Farapulse, Inc. is approved for marketing by China NMPA.
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China's Medical Device Standards Reach 1978 in Total
2025-02-19
Up to now, the number of medical device standards has reached 1978, including 272 national standards and 1706 industry standards; 269 mandatory standards and 1709 recommended standards, basically covering all professional and technical fields of medical devices.
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China deepens comprehensive reform to strengthen drug, medical device regulation
2025-01-06
China has issued a guideline on comprehensively deepening the reform of regulation of drugs and medical devices to promote the high-quality development of the pharmaceutical industry.
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1st stem cell therapy, new HIV drug approved
2025-01-06
China's top drug regulator has recently approved the nation's first stem cell therapy to treat a type of complication associated with bone marrow transplant, as well as a novel HIV drug that only requires two shots yearly.
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Xu Jinghe attends Global Harmonization Working Party annual meeting
2024-12-23
Xu Jinghe, deputy commissioner of China's National Medical Products Administration, attended the 28th annual meeting of the Global Harmonization Working Party (GHWP) and the 28th GHWP Technical Committee Meeting, which were held in Kuala Lumpur, capital of Malaysia, from Dec 9 to 12.
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The 1st GHWP Innovation Medical Device Symposium Held Grandly
2024-12-20
On April 12, the First GHWP Innovation Medical Device symposium was held in conjunction with the 89th China International Medical Equipment Fair, attracting more than 200 experts from regulatory authorities and industries of GHWP member countries and regions.