Chinese market access
How to work with us
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We accompany the whole registration process from preparation of dossier to product approval and post market activates of medical device or IVD.
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We support your project depending on your need in term of hourly contingency. You might need a gap analysis or expert opinion. Or the experts in our team communicate with all stakeholder as RA lead, R&D, Chinese authority, registration partner or distributor.
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We act as interim manager upon project.
Regulatory gap analysis of Chinse registration of medical device (IVD)
Remember the first gap analysis of regulatory strategy is gratis if you want to mark your medical device in China.
We will provide you a starter kit with the most important regulations and checklists to have self-assessment of NMPA registration.
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Whether your product is a medical device in China, which product code and classification apply to your medical device, whether the clinical evaluation and study is needed and which competitors and distributors are existing in China already, everything in term of a gap analysis will grant you a wise overview and plan of Chinese commercialization.
Now you decide to register medical device and IVD (Class I, II, III) in China.
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We will accompany you in a transparent preparation. From the beginning on you will be clear with general NMPA regulations and product specific-guidance and standards. We will outline the highlight of demanding Chinese on-site type testing and clinical evaluation.
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Finally we will submit technicial documentation to NMPA and reply the deficiency till approval.
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Our purpose is not only to get your product approved, but also to make next product registration on your own, independent of unnecessary consultation.
Other compliance services in medtech around China
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Based on our expertise we can support at:
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1 Year academy of E-Leaning with own coach
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Training of Chinese registration onsite and remote
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Lean workshop of regulatory mind-set onsite and remote
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Regulatory monitoring
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Clinical evaluation
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Clinical study
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Product technical requirement and type testing
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Management of Labelling and Code (Label, IFU, UDI, insurance code)
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Audit of Chinese partners (consultant, production, supplier) compliant to ISO 13485 or ISO 9001 plus Chinese GMP or GSP
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Post market as adverse event report , period risk evaluation report, annual self-examination report
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Document translation in Chinese with examination from regulatory view
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Design control (assessment of significant product changes)
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From MDR or US FDA to Chinese NMPA
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From ISO 13485 to Chinese GMP
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Due diligence (M&A either from China or to China)
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