| 英文摘要 |
On the basis of the ''Guidance on Laboratory Developed Tests and Services (LDTS) for Precision Medicine Molecular Testing,'' TFDA subsequently released several documents including ''Application Notes on the Registration of Laboratory for Precision Medicine Molecular Testing,'' ''Management Regulations of Laboratory for Precision Medicine Molecular Testing'' and ''Review of Application for Registration of Laboratory for Precision Medicine Molecular Testing and Operational Principles of Non-regular Inspections'' to inform the industry about the details of LDTS registration. These guidance documents, released step by step, now form a comprehensive regulatory framework for LDTS for precision medicine molecular testing in Taiwan. |
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