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BioWorld - Tuesday, June 16, 2026
Home » Topics » Regulatory » NMPA

NMPA
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In boon to sector, surgical robots receive NMPA approvals

April 29, 2022
By Zhang Mengying
The NMPA approved two different surgical robots for marketing, a step forward in growth of a sector that remains underdeveloped in China. One of the robots approved for marketing by the NMPA is from Yuanhua Orthopedic Robotic Ltd. and the other is Suzhou Microport Orthobot Co. Ltd. Both robots are used for total knee arthroplasty (TKA), removing damaged cartilage and bones from the surface of the knee joint and replacing them with artificial implants.
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Varicose veins concept art

Acotec wins NMPA nod for radiofrequency ablation to treat varicose veins

April 19, 2022
By Doris Yu
Acotec Scientific Holdings Ltd. has received marketing approval for its radiofrequency ablation system from China’s NMPA to treat varicose veins. The radiofrequency ablation system consists of an endovenous radiofrequency catheter and a radiofrequency generator.
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Walvax wins NMPA nods for HPV bivalent vaccine

March 29, 2022
By Doris Yu
China’s NMPA has given a green light for Walvax Biotechnology Co. Ltd.’s human papillomavirus (HPV) bivalent vaccine to be used against HPV types 16 and 18 to prevent cervical cancer.
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Walvax wins NMPA nods for HPV bivalent vaccine

March 28, 2022
By Doris Yu
China’s NMPA has given a green light for Walvax Biotechnology Co. Ltd.’s human papillomavirus (HPV) bivalent vaccine to be used against HPV types 16 and 18 to prevent cervical cancer.
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Chinese flag on flagpole

Sihuan awarded medical device registration for skin repair products by NMPA

March 18, 2022
By Doris Yu
China’s NMPA has given 10 of Sihuan Pharmaceutical Holdings Group Ltd.’s skin repair products medical device registration certificates. The products are developed by its medical aesthetics platform Beijing Meiyan Kongjian Biology Medicine Co. Ltd. The certification is for three scar repair products, four medical dressing and patch products, as well as three skin repair products.
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SARS-CoV-2 illustration turns from blue to red

NMPA approves 12 antigen self-test kits

March 16, 2022
By Zhang Mengying
China’s NMPA has approved 12 antigen self-test kits between March 12 and 16 amid COVID-19 outbreaks in many parts of the country. The regulator claims that there will soon be more test kits approved. The number of COVID-19 infectious cases in China surged rapidly over the first half of March.
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Chinese flag, pills

China NMPA speeds up NDA reviews to encourage new drug development

March 15, 2022
By Doris Yu
The NMPA’s Center for Drug Evaluation (CDE) published a draft document named the Pilot Work Procedure to Speed Up the Review of Innovative Drug NDAs in February 2022. It aims to accelerate the review of new drug applications (NDAs) in China.
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Psychotherapist evaluates patient using VR therapy for acrophobia

Neuton Health’s VR therapy for acrophobia receives NMPA class II approval

March 14, 2022
By Zhang Mengying
Neuton Health Co. Ltd.’s virtual reality (VR)-based therapy for acrophobia has been given class II medical device approval from China’s NMPA. The VR therapy, known as Specific Fear Rehabilitation Training Software, was co-developed with the Shanghai Mental Health Center. The digital therapy company said it is the first VR device of its kind for a specific phobia approved in the world.
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Chinese flag, pills

China NMPA speeds up NDA reviews to encourage new drug development

March 11, 2022
By Doris Yu
The NMPA’s Center for Drug Evaluation (CDE) published a draft document named the Pilot Work Procedure to Speed Up the Review of Innovative Drug NDAs in February 2022. It aims to accelerate the review of new drug applications (NDAs) in China.
Read More
Skin, tissue layer illustration

Sihuan awarded medical device registration for skin repair products by NMPA

March 4, 2022
By Doris Yu
China’s NMPA has given 10 of Sihuan Pharmaceutical Holdings Group Ltd.’s skin repair products medical device registration certificates. The products are developed by its medical aesthetics platform, Beijing Meiyan Kongjian Biology Medicine Co. Ltd.
Read More
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