In recent years, GHWP has been liaising to GHTF in drafting and revising guidance documents on IVD medical devices regulations. Topics like definition, risk-based classification, conformity assessment and technical documentation of IVD medical devices have been covered in the documents.
In order to know IVD medical devices regulations of GHWP member economies and to find out the obstacles and difficulties met upon adopting GHTF documents, the WG01a IVDD Subgroup carries out this survey. Based on the feedback from the member economies, the subgroup will conduct gap analyses and make recommendations to the member economies in harmonizing IVD medical devices regulations.
Please fill out the attached form and return it to the Chair and Co-chair of WG01a by sending emails to both EMMohandis@sfda.gov.sa and JFChern@itri.org.tw or by fax to both +966-1-2757245 and +886-3-5734092 before Jan 31, 2010.
Thank you very much!