China Rejects Medical Device Registration Applications with Data Authenticity Issues

by Grace Wang Mar 24, 2021

On Jan. 15, 2021, China National Medical Products Administration (NMPA) rejected a company's medical device registration application because of the data authenticity issue in the clinical trial.1

In Nov. 2020, NMPA carried out clinical trial onsite inspection on ten medical device registration application projects under review, involving 27 clinical trial institutes. The HIV Ab/hepatitis B Ab/hepatitis C Ag/Syphilis Ab combination kits produced by a company based in Hangzhou was found the problem of data authenticity in the clinical trial. The time and location of the electronic photos kept on file were inconsistent with the actual time and location of the clinical trial. Therefore, the clinical trial's data source was deemed untraceable.

Apart from refusing its registration application, NMPA also stated that it would not re-accept the application of this testing kit within one year from the date it was rejected. The authority also sent notice to the local drug administrator for further investigation on the project, including the applicant, CRO and clinical institutes; the local drug administration was also required to report the investigation result to NMPA.

NMPA ordered all applicants and clinical trial institutes to conduct clinical trials stringently following the Good Clinical Practice for Medical Devices 2. They should fully carry out their duties to ensure that the clinical trial's procedure is scientific and legal and the result is authentic and reliable. All provincial drug administrators shall attach great importance to the supervision and management of medical device clinical trials.

China has made it clear that it would investigate and punish data falsification strictly in the Opinions on Deepening the Reform of the Review & Approval System to Encourage the Innovation of Drugs and Medical Devices 3 published in Oct. 2017. In recent years, the country's medical products regulator did deny many registration applications for medical devices like a domestic company's HBeAg detection kit and an overseas company's absorbable collagen sponges for hemostatic use. 4

Grace Wang
ChemLinked Regulatory Analyst & Editor
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