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Global Medical Device Standards

Here is a partial Sampling of some of the key Medical Device Standards from around the world:

• ISO Standards for Medical Devices
• US FDA
• Europe (MEDDEV or EU MDD)
• Canada (CMDR)
• Japan

ISO Standards and Guides for Medical Devices

• ISO 13485-2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
• ISO 13485/Cor1:2009 Medical devices - Quality management systems - Requirements for regulatory purposes - Corrigendum 1
• ISO 15189-2007 - Medical Laboratories - Particular Requirements for Quality and Competence
• ISO 15378-2006 - Quality Management Systems - Primary Packaging Materials for Medicinal Products - Particular Requirements for the Application of ISO 9001:2000, with Reference to Good Manufacturing Practice (GMP)
• ISO 9001-2008 - Quality Management Systems Requirements
• ISO 14971-2007 - Medical devices - Application of risk management to medical devices
• ISO Guide 73-2009 - Risk management - Vocabulary
• ISO/TR 14969-2004 - Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003
• ISO/TR 16142-2006 - Medical Devices - Guidance on the Selection of Standards in Support of Recognized Essential Principles of Safety and Performance of Medical Devices
• ISO/TS 20993-2006 - Biological Evaluation of Medical Devices - Guidance on a Risk Management Process

US FDA Medical Device Regulations & Guidelines

• Design Control Guidance for Medical Device Manufacturers
  Text related to FDA 21 CFR 820.30 and sub clause 4.4 of ISO 9001.
• Labeling for Medical Devices
  Guidance on medical device labeling from the FDA
• Quality Systems Regulations (QSR)
  US FDA QSR regulation and Good Manufacturing Practices (GMP).
• Post Market Surveillance
  Guidance on criteria and approaches for medical device post-market surveillance.
• Human Factors in Medical Device Design
  Discusses the CDRH push to have manufacturers apply Human Factors to device design.

European Medical Device Regulations Directives (MEDDEV):

• Active Implantable Medical Devices Directive (AIMDD)
  Full text of European directive 90/385/EEC that governs active implantable medical devices.
• In-Vitro Diagnostic Devices Directive (IVDD)
  Full text of the European IVD directive 98/79/EC that governs in-vitro diagnostics.
• Medical Device Directive, Full Text (MDD)
  Full text of the European Medical Devices Directive 93/42/EEC.
• Personal Protective Equipment Directive (PPE)
  Full text of the European directive 89/686/EEC that governs personal protective equipment.
  

Canadian Medical Device Regulations (CMDR)

• Health Canada's definition of Medical Devices
• Canadian Medical Devices Regulations
  Full text of the Canadian MDR as part of the Food and Drugs Act of 1998.
• Transition to ISO 13485:2003
  Brief document that discusses timeline for transitioning to ISO 13485:2003
• ISO 13485 Audit Guidelines
  Guidance document that discusses ISO 13485 QS audits performed by CMDCAS registrars.
• Officially Recognized Registrars
  Listing of registrars recognized by Health Canada and standards to which they may audit.
• Health Canada Licensing Fees
  Document detailing all medical device licensing and other fees for Canada.

Australian Medical Device Regulations (ARGMD)

• Australian Medical Device Regulations

Japanese Medical Device Regulations & Guidelines

• Japanese Requirements Review - January 2005