GHTF issues revised document "Definitions of ‘Medical Device’ and ‘IVD’
Dear All
The GHTF (Global Harmonization Task Force) released a final document on “SG1-N71:2012 – Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device”. It provides a definition of a term that is used in all GHTF publications. The GHTF first published guidance on this subject in a document entitled GHTF/SG1/N29:2005 Definition of the Term 'Medical Device'. This document supersedes that previous version. It has been changed to:
• modify the definition of ‘medical device’;
• provide a definition for the term 'In Vitro Diagnostic (IVD) medical device';
• provide ancillary definitions for 'accessory to a medical device' and ‘accessory to an IVD medical device’ in Section 4.0 of the document; and
• clarify the ‘Notes’ within the document.
For more details, refer attached pdf..
Regards
S. Subramaniam
Dear All
The GHTF (Global Harmonization Task Force) released a final document on “SG1-N71:2012 – Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device”. It provides a definition of a term that is used in all GHTF publications. The GHTF first published guidance on this subject in a document entitled GHTF/SG1/N29:2005 Definition of the Term 'Medical Device'. This document supersedes that previous version. It has been changed to:
• modify the definition of ‘medical device’;
• provide a definition for the term 'In Vitro Diagnostic (IVD) medical device';
• provide ancillary definitions for 'accessory to a medical device' and ‘accessory to an IVD medical device’ in Section 4.0 of the document; and
• clarify the ‘Notes’ within the document.
For more details, refer attached pdf..
Regards
S. Subramaniam
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