Standard Application Format And Guidance Document

Guidance on Preparation of a Product Registration ... - ASEAN

and the format that this information is to be submitted in. 1.2. Background The ASEAN CSDT document contains elements of the GHTF guidance document titled “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)” (Document number: SG1/N011R17). The ASEAN …

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