21 CFR PART 820 o Presentation: Quality System Regulation 21 CFR 820 - Basic Introduction European Medical Device Regulations o European Medical Device Regulations o Regulation of Medical Devices in the United States and European Union o Guidance MEDDEVs 510 K Submissions o 510(k) Submission Process o The US FDA 510(k) Submission Process o 510(k) Submission Methods o 510(k) Clearances o Premarket Notification (510k) PMA Submissions o PMA Approvals o Submission Services o Pharmaceutical Industry: Post Marketing Authorisation Approval o Post-Marketing Authorisation: Regulatory and Procedural Guidance Australia http://www.tga.gov.au/industry/devices.htm China http://eng.sfda.gov.cn/WS03/CL0759/ India http://cdsco.nic.in/google/FRONT%20PAGE%20A.html Japan http://www.pmda.go.jp/english/service/regulation.html Malaysia http://www.mdb.gov.my/mdb/ NewZealand http://www.medsafe.govt.nz/devices/devices-landing.asp Singapore http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/medical_devices.html
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