Updates on Global Medical Device Registration and Regulation Processes

119 pages. The paper on Understanding the Requirements of European Medical Device Regulation (EU MDR 2017/745) was presented by Captain A. Rajkumar at the webinar titled Updates on Global Medical Device Registration and Regulation Processes. The webinar was held on 26 August 2021 and aimed to create awareness of various types of medical devices, their risk-based categories and classifications based on FDA and Medical Device Directives (MDD). Participants were exposed to standards like ISO 13485, ISO 14971 and 21 CFR Part 820 including GDPMD Act 737 and acquired recent developments and updates on the standards. Among the topics discussed were 1) The Need for a Regulatory Authority for the Industry 2) Device Classifications 3) Risks to Humans by Devices 4) Risk Based Classifications 5) Regulations EU, US, Australia, Malaysia and Canada 6) Quality Management Systems for Medical Devices 7) Failure to Comply - Risks to the Manufacturer and 8) Best Practices & Approach Towards Compliance(s).