Call for Comments on the Proposed Document 'Guidance Document for Medical Device Organizations-Product Localisation for Manufacturing and Importation'

Submitted by admin on Thu, 09/12/2024 - 14:45

For your kind perusal, please find attached the WG7 Proposed Document 'Guidance Document for Medical Device Organizations-Product Localisation for Manufacturing and Importation'.

Call for Comments on the Proposed Document 'Software as a Medical Device (SaMD) Pre-Market Submission Requirement – Comparison of requirement from Key jurisdictions'

Submitted by admin on Thu, 09/12/2024 - 14:44

For your kind perusal, please find attached the WG3 Proposed Document 'Software as a Medical Device (SaMD) Pre-Market Submission Requirement – Comparison of requirement from Key jurisdictions '.