Service Item
Registration Services
Beijing RunHuge STD., provide one package solution of medical devices registered in China for more than 20 years including technical standards, product testing, clinical evaluation, R&D planning, quality system, is dedicated to the delivery of registration services for global manufacturers. We have accumulated plentiful experience in registration industry and fully used our high-quality resources to serve more than 3,000 enterprises covering over 98% of the products in classification catalogue. Our services include proposal planning, category classification, report compilation, testing & verification, prototype correction, registration declaration.
Domestic Medical Devices
Medical devices in China can be divided into three categories according to the level of its own risks, that is, Class I, Class II and Class III. Product belongs to different levels should either be filed or registered in accordance with the registration law made by NMPA. Therefore, it is crucial to define which level the medical device belongs to before registration application.
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Import Medical Devices
Medical devices in China can be divided into three categories according to the level of its risks, that is, Level I, Level II and Level III. Product belongs to different levels should either be filed or registered in accordance with the registration law made by NMPA. Therefore, it is crucial to define which level the medical device belongs to before registration.
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IVD
In-vitro reagents hereby refers to the ones managed as medical devices, include IVD kits, calibrators and quality control materials either to be used alone or in combination with any instrument, apparatus, appliance and software. It is intended to detect body samples, such as all kinds of body fluids, cells, tissue samples in order to diagnose, monitor, prevent diseases from happening, evaluate health condition and predict hereditary diseases.
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Innovative Products
Definition of Innovative Medical Device:brand-new products emerged in domestic market or safety, effectiveness and functional mechanism haven't been proved yet.
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Classification
申请人根据相关法规确定产品类别,对于新研制的尚未列入《分类目录》或分类界定通知等文件的医疗器械,按照《医疗器械监督管理条例》第十六条规定向医疗器械标准管理中心(简称标管中心)申请类别确认。
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