On November 14th 2017, Center for Medical Device Evaluation (CMDE) released "The Draft of the Guidance of Accepting the Overseas Clinical Trial Data for Medical Device", which is applicable to medical devices (including in vitro diagnostic reagents, IVDs).
More The Clause 29th of "The Guidance of Registration for In-vitro Diagnostic Reagent” clarifies that for in-vitro diagnostic (IVD) reagents exempt from clinical trial, the applicant is responsible for the evaluation of the clinical performance of the IVD reagents by means of evaluating the clinical samples from the intended use, interference factors, comprehensive literatures and other pre-clinical data.
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In order to improve the design of clinical trials of medical devices in the country, the Center for Medical Device Evaluation (CMDE) drafted the guidelines for the design of clinical trials of medical devices, and asked for the public’s opinion.
More Ministry of Science and Technology of the People´s Republic of China published the new administration process of human genetic resources in clinical trial in the end of October.
More China Food and Drug Administration (CFDA) is planning to require foreign registrants to provide its company information in Chinese, such as company name and addresses.
More On September 4th 2017, China Food and Drug Administration (CFDA) officially published the new revision of "Medical Device Classification Catalog". It will be implemented from August 1, 2018
More Qualtech was invited by OMETA (Overseas Medical Eauipment Tech. Assistants) to give the speech of regulatory registration in Taiwan and China.
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