The Medical Devices Introductory Course 2020

The Organisation for Professionals in Regulatory Affairs

Medical Device Regulation – Rest of the World

• Most markets have specific medical device legislation: • Canada (similar to CE requirements) www.phac-aspc.gc.ca • Australia (similar to CE requirements) www.tga.gov.au • Korea (similar classification to EU, strict requirements for higher class, updated regulations recently to reduce requirements for class I devices) www.mfds.go.kr • China (rely on product testing for most registrations, similar classification system, complex process with in-market clinical tests and and long review periods) NMPA www.nmpa.gov.cn • South Africa (new MD regulation in 2017, previously device registration not applied or built on drug legislation). New agency SAHPRA www.doh.gov.za • Russia (rely on product testing as part of regulatory process, similar classification) http://www.roszdravnadzor.ru • Brazil (medical device registration process with both preapproval submission and administrative review processes, similar classification to EU, but historically long delays in registration (due to testing e.g.: INMETRO and audit requirements - now taking part in MDSAP) www.anvisa.gov.br Health Canada www.hc-sc.gc.ca