Consulting ServicesMedical DevicesRegulatory Information Management

China Product Registration, Renewal, Modification


Booth: 432

Depending on where you plan to sell your device(s), successful registration may involve substantial effort to meet premarket technical and clinical submission requirements or leveraging your existing registrations and approvals to gain faster access to new markets. China Med Device can assist you in registering your medical device products. Our regulatory consultants are diligent in preparing and reviewing medical device registration documents. We will take the following steps to minimize additional documentation requests from the approval body and other delays: Face-to-face Consultation with NMPA Reviewer: China Med Device, LLC can help you research and prepare the questions, and get feedback from NMPA reviewers. You can ask questions related to the registration process ranging from registration category, pathway strategy, technical standards and local type testing, clinical trial endpoint, overseas clinical data, etc. Type Testing Support: China Med Device, LLC have onsite test engineers at the NMPA testing centers to support and facilitate the tests between the NMPA testing center engineers and the reviewers. We have an extensive technical background to handle difficulties for our clients. Registration, Renewal & Modification: China Med Device has successfully obtained 1000+ China NMPA certificates for our client. Our integrated regulatory, technical, and clinical team can help you prepare required documents, give on-site type testing support, provide full CRO service to accelerate your process for registering your product in China. Fast-track Pathway - Innovation, Priority and Emergency

Other product: CRO Services

Other product: IVD & CDx Expertise

Other product: RA Strategy & Consulting

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