The STED format was created by the Global Harmonization Task Force (GHTF), the precursor to the current International Medical Device. The Global Harmonization Task Force (GHTF) website is no longer operational. For information about medical device harmonization, please go to. Full Title: The Global Harmonization Task Force (GHTF) Summary Technical Documentation (STED) for Demonstrating Conformity to the.
|Published (Last):||15 July 2010|
|PDF File Size:||2.8 Mb|
|ePub File Size:||14.69 Mb|
|Price:||Free* [*Free Regsitration Required]|
However, a prevalent issue found in the preparation and submission of technical documentation with regulatory authorities RA around the world had been the irregularity of this dossier format.
It allows the RAs to conduct conformity assessment of the medical devices, according to local and international standards set in place.
The STED reflects the status of the medical device at a particular moment in time e. The content of the CSDT resembles the STED, in terms of the compilation of summary information on selected topics, and inclusion of detailed information on other specific topics and an Essential Requirements checklist. Eliminating differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier stev to new technologies and treatments.
STEDs are required to contain summary information on selected topics, and may contain detailed information on certain specific topics and an Essential Principles checklist.
GHTF Study Group 1 – Pre-market Evaluation
The information provided may include, for example, abstracts, high level summaries, or existing controlled documents, as appropriate, sufficient to communicate key relevant information and allow a reviewer to understand the subject and assess the validity of that information.
Getting to know the CSDT. The GHTF includes these requirements as headings only, with the detailed requirements included in separate guidance documents.
Technical documentation are the documented evidence, normally an output of the quality management system, which demonstrates conformity of a device to the Essential Principles of Safety and Performance EPSP of Medical Devices. However, the depth of details to be covered by these topics differ between the STED and CSDT, including the format of certain administrative documents to be submitted.
The agreement is expected to come into full effect startingstdd many of these member states already adapting the directive into regulating their own medical device industry. The STED template is widely accepted by RAs all over the world, except when there is a slightly different technical documentation template implemented in certain countries. Without proper formatting, the most meticulously researched and prepared medical device market application can fail to pass regulatory review, costing the applicant time and money.
The CSDT incorporates the requirements for labelling and instructions for use, as well as for clinical evidence.
The core content of each document is the required content of the technical documentation to be submitted to a regulatory authority. Apart from the above mentioned aspects, the other aspects of the STED and the CSDT use the same set of technical documents, albeit in different arrangements.