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Australian Government - Department of Health and Ageing Therapeutic Goods Administration - Regulation of therapeutic goods including medical devices. TGAwiki


Health Canada
Health CandadaWiki
Industry Canada
Telecommunications Spectrum Management - Standards Specifications


Pharmaceutical and Medical Agency PMDA

Pharmaceutical and Medical Devices Evaluation PMDEC

Japan Association for the Advancement of Medical Equipment JAAME
(Equivalency review for device)

Organization for Pharmaceutical Safety and Research OPSR
(Drug clinical trial consultation, equivalency review)

New Zealand

New Zealand Medicines and Medical Devices Safety Authority


EMEA - European Medicines Agency

Electromagnetic Compatibility Directive (89/336/EEC & 2004/108/EC) Enforced by European Commission

Radio & Telecommunications Terminal Equipment Directive (R&TTE)

Notified Bodies for Radio Terminal and Telecommunications Equipment ec.europa.eu

United States

October 1, 2012
FDA Newly issued guidance to industry Access Here

FDA Guidance "Recognition and Use of Consensus Standards" Sept 17, 2007

Inspection Technical Guide Computer Systems I 

Part II Computer Hardware Inputs & Outputs 

Guidance to Industry "Computerized Systems Used in Clinical Trials"

FDA Draft Guidance "Electronic Medical Device Reporting" August 21-2009

FDA Guidance for Review "Electronic Source Documentation in Clinical Investigations"

FDA Guidance for the "Content of Premarket Submissions for Software Contained in Medical Devices". May 11, 2005

FDA Guidance "Addition of URL's to Electronic Product Labeling" September 30, 2010

FDA Guidance "Medical Device Tracking" January 25, 2010

FDA Guidance "Design Control Guidance for Medical Device Manufacturer's" 21 CFR 820.30 & Sub-clause 4.4 of ISO 9001

FDA Guidance "General Principles of Software Validation" Final Jan 11, 2002

FDA Guidance for Comment "Radio-Frequency Wireless Technology in Medical Devices" Jan 3, 2007

FDA Inspection Technical Guidelines - Evaluation of Production Cleaning Processes for Electronic Medical Devices Parts I,II and III. Part II Cleaning Solvents  
Part I Contaminants

FCC (Federal Communications Commission) FCC National Broadband Plan required by American Recovery and Reinvestment Act of 2009 for improving broadband Internet access throughout the United States.  Click to download National Broadband Plan

Guidance to Industry, Foreign Governments & FDA 2011 Medical Device User Fee and Small Business Qualification & Certification


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