In this episode, I will update you regarding all the changes in the Medical Device Quality and Regulatory Field. Below are all the topics we will discuss during this episode. Don’t miss the latest updates.

EU

• EUDAMED & Certificate: https://ec.europa.eu/health/medical-devices-eudamed/notified-bodies-and-certificates-module_en

USA

• MDSAP Audit Approach: https://www.fda.gov/media/157861/download

MEA

• Ethiopia: Labelling requirements: http://www.fmhaca.gov.et/wp-content/uploads/2022/04/Guidelines-for-Medical-device-Labeling.pdf

ASIA

• Malaysia: Labelling requirements: https://www.mda.gov.my/documents/draft-guidance-documents/1969-attachment-1-public-comment-mda-gd0026-requirement-on-labelling-of-md/file.html

EVENT

• Medtech Forum: https://www.themedtechforum.eu/

GUIDANCES

• MDCG Subgroup development and deliverables – https://ec.europa.eu/health/system/files/2022-04/mdcg_ongoing_guidancedocs_en.pdf

NOTIFIED BODIES:

• IVDR: 3EC international. https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317359&version_no=3

Easy Medical Device Nostalgia:

• Episode 175: How to prepare an audit with Front Room Back Room: https://podcast.easymedicaldevice.com/175/