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With North America, the European Union and Japan accounting for an estimated 85% of the global medical device market, there is little mystery surrounding why firms concentrate their compliance strategy efforts on these markets.  Even with the substantial harmonization results achieved by the Global Harmonization Task Force (GHTF), these markets continue to enforce unique requirements for establishment registration, device approval, quality system requirements, and adverse event reporting.

The resources below reflect the most frequently referenced information in response to medical product firms’ questions regarding FDA and international compliance.   Also included below are two informational reports covering the global medical device market and regulations – one by the US Department of Commerce and another by the World Health Organization.  Use the icon and text links to progressively drill down to the level of detail necessary.


Regulations & Standards

 Document Description Comments
Quality System Regulation/
Medical Device Good Manufacturing Practices
The QSR is the result of the FDA’s revision of the cGMP regulation to make the regulation more consistent with the requirements of ISO 9001:1994 and ISO 13485. Firms commonly use their Quality Manual to map their compliance strategy with each QSR provision. For more FDA information:
Pre-Market Notification
Section 510(k)
Medical Devices
- Quality Management Systems -
Requirements for Regulatory Purposes
ISO 13485:2003 requirements are specific to medical devices and exclude some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, a firm’s quality management systems may conform to ISO 13485, but may not necessarily conform to ISO 9001. For more information:
CE Marking Before medical products can be placed on the European market, they must meet the requirements of the relevant European Economic Community product Directive. These Directives define product classification/requirements, certification, post-market monitoring, incident reporting and other CE Marking requirements. For more information:
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is responsible for regulating the country’s drugs and medical devices. This link provides access to the English version of their website: To access the PMDA website:
Health Canada is the Canadian equivalent to the US FDA and similarly reviews drugs and medical devices for their safety, effectiveness and quality before being offered for sale in Canada. Canada requires compliance with ISO 13485:2003 for manufacturing (Class II) or design and manufacturing (Class III & IV). See the Guidance for comparison of FDA QSR, European and Canadian regulations:
A clause- by-clause comparison between the FDA QSR and 13485:2003 requirements prepared by Pilgrim Software.
Risk Management is considered essential for ensuring the safety and reliability of medical devices by both ISO 13485:2007 and the FDA QSR. ISO 14971 is specifically referenced within ISO 13485 and is recognized by the FDA as an acceptable risk management model.

Related Tools & Topics

 Document Description Comments
The Global Harmonization Task Force (GHTF) has assumed the leadership position for international harmonization in the regulation of medical devices.  This site provides informative guidance on quality systems, auditing and risk management, among other topics. 
Global Harmonization Task Force (GHTF) PowerPoint presentation of ISO 13485:2003 – provides comprehensive implementation guidance.
PowerPoint presentation of ISO 14971:2007 made at the 11th Conference of the GHTF by the ISO/IEC Joint Working Group – provides overview and guidance for implementation.
Article in Medical Device and Diagnostic Industry magazine discussing the impact of the recent Bilski decision (June 2010) on the machine-or-transformation test historically used to determine medical method patentability.
The Organization for Economic Co-Operation and Development (OECD) – a forum comprised of 30 countries including the US, European Union, Canada and Japan – issued this QA guidance for molecular genetic testing.
A little-known, but very useful e-Handbook published online and jointly maintained by the US National Institute of Standards and Technology (NIST) and SEMATECH, a consortium of major semiconductor manufacturers, covering a great variety of statistical tools and techniques – including process control, sampling plans, design of experiments, etc.
An adequate ESD Control program is essential for any company manufacturing or otherwise handling static-sensitive electronic products. Experienced auditors will thoroughly examine the implementation of a firm’s ESD Control program. For more ESD Control information:
This OSHA publication provides general guidance for preparing the written plans reguired by OSHA and includes samples of documentation.
Although the document is several years old, and has not been updated, it still provides an interesting overview of the global medical device market with respect to the top producers, consumers, emerging markets and evolving regulatory climate.
A fairly recent (2010) assessment of the medical device industry prepared by the US Department of Congress.  It examines the global markets, including the role of the GHTF and upcoming changes to be introduced by the FDA.
Resources for Design for Assembly (DFA), Manufacturability (DFM), Testability (DFT) and Servicability (DFS). For more information: