Medical Device China Entry Case Study

Case One: Human Gene Detection Kit Overcame Extra Challenge to Complete Clinical Trials

The challenge: Client’s Human Gene Polymorphisms Detection Kit is required to conduct clinical trials to pass CFDA product registration. Because this test is used to guide patient medication instruction, its clinical trial is required to record patients’ medication information in addition to gather patients’ blood sample. In order to record patients’ medication information, client is required to obtain informed consent from each patient.

The need for patient informed consent creates extra challenge to this clinical trial because regular IVD clinical trials does not require patient informed consent. (trials are conducted by using qualified left-over blood samples in hospitals). The case becomes even more challenging because the clinical trial designated hospital happens to serve mainly minority population.

The solution: Our team first expanded sample patient pool in order to identify enough willing patients. We then used years of experience to work with the doctors to gain their support to obtain patient informed consent. We then worked with relevant CFDA officials in advance to ensure full support for this application.

The result: In the end, client completes clinical trials successfully and obtained CFDA registration license. 

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Case Two: C-Reactive Protein Test Reagent Completes Registration Six Months Sooner

The challenge: Client wants to register 7 IVD products all together in a timely manner. Each reagent requires clinical trial. Normally it would take 18 months per product and usually CFDA requires additional evidence during application.

The Solution: Our team worked diligently during document preparation to make sure it covers all possible regulations. Our team proactively engaged CFDA officials during application preparation to strive for prompt review attention.

The Result: All 7 registration applications were accepted with no additional evidence required. All clinical trials were accepted successfully. Within 12 months, client received all registration licenses. Our work saved six months of time for the client. 

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