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