CDSCO
The new article goes into further detail regarding the record-keeping requirements, as well as quality assurance in the context of clinical investigations intended to be conducted in India.
CDSCO
The last article from the cycle elaborates on the applicability of the principles and approaches described in the guidance in special cases.
FDA
The article outlines the basics of chemical analysis in the context of biocompatibility of medical devices.
Swissmedic
The article outlines the approach to be applied with respect to legacy medical devices in the context of transitional provisions.
FDA
The new article provides further clarifications related to gathering additional information.
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