Monthly Industry Report - What happened in this month

2021-11-30

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NMPA

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NMPA

Notice on public solicitation of opinions on the filing and examination requirements of medical devices and in vitro diagnostic reagents application projects1654495750316077.png1654494280624212.png


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NMPA

Requirements for filing and examination of medical devices and in vitro diagnostic reagents application projects for public comments

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CMDE

Interpretation of < The guiding principles for the registration and review of animal experimental research on medical devices

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NMPA

Notice on printing and distributing the operation specifications for the registration and approval of domestic class III and imported medical devices

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NMPA

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 LINKS CRO 

       As a CRO company providing clinical trial services. LINKS CRO focus on innovation, high-risk implantation(intervention) medical device, with one-stop clinical trial solutions for the whole process of medical device research and development.The headquarters of LINKS is based in Shanghai, with subsidiary branches in Beijing, Shanghai, Guangzhou, and Shenzhen, in addition to ten regional offices. The current workforce comprises almost 200 employees, with technical personnel making up over 85% and dispersed across almost 30 cities nationwide.   

      Key Services include CRO, SMO, CER, Audit, Post-market research, core laboratory registration both domestically and overseas, innovation declaration, Expert Consultancy, and overseas enterprise agency services.

      Key Indications include Cardiovascular, Neurovascular, Peripheral Vascular, Surgery Robot, Oncology, Ophthalmology, Medical Cosmetology, and other fields such as orthopedics. There are almost 300 projects consultations and services by LINKS each year.  1656657914619364.gif