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Journal of Medical Device Regulation Issue Headlines - August 2010

Transparency or Exposure in the USA – It Depends on Which Side of the Window you’re on…

The US Food and Drug Administration (FDA) has formed an internal Task Force that is responsible for developing recommendations for ‘enhancing the transparency of FDA’s operations and decision making’. The Task Force decided to execute its Transparency Initiative in three phases: Phase 1 - FDA Basics; Phase 2 - Public Disclosure; and Phase 3 - Transparency to Regulated Industry. Rosina Robinson’s article is primarily focused on Phase 2 which, in addition to providing newly-accessible information to the general public, also has many implications for medical device manufacturers as well as other FDA-regulated industries. More >>

Labelling of Medical Devices in Asia

In today’s global economy, medical devices may be designed in one country, manufactured in another and used by medical professionals and lay persons worldwide. With only a few exceptions, medical devices are supplied with labelling. Global labelling requirements can appear to be a minefield for manufacturers of medical devices. However, documents created by organisations like the Global Harmonisation Task Force and the Asian Harmonisation Working Party are beginning to have an impact on reducing the differing requirements imposed by regulatory authorities when creating their own medical device regulations. In this article, Donald Sherratt examines the labelling requirements for medical devices in Asia, including the language requirements and accepted use of symbols. More >>

Adverse Event Reporting in the EU and the USA: Similarities and Differences

In this article, Elisabethann Wright and Steven Datlof compare and contrast the rules applicable to the reporting of adverse events in relation to medical devices in the European Union with those applicable in the USA. More >>

A Critical Examination of MEDDEV 2.7.1 rev 3

MEDDEV 2.7.1 Rev 3 (December 2009), entitled Clinical evaluation: A guide for manufacturers and Notified Bodies, revises the April 2003 version of the MEDDEV, apparently aligns with Global Harmonisation Task Force Guidance SG5/N2R8: 2007, Clinical evaluation, and accommodates amending Directive 2007/47/EC. Haroon Atchia examines the content of this revised MEDDEV guidance document, as well as questioning its legal status and method of preparation. More >>

A Review of Market Entry Requirements for Risk Management, With Special Emphasis on FDA and ISO 14971 Compliance

By nature, many medical devices can carry a significant amount of risk, especially those used on particularly ill patients or those devices that are intended to be life sustaining or life supporting. Therefore, an understanding of the risks inherent in the application of medical devices and risk management has always been a part of the design, manufacture and post-production processes associated with placing medical devices on the market. However, the formal requirements for risk management and enforcement of risk management vary depending on where the device will be sold and used. In this article, Mark Leimbeck and Larry Kessler review the market entry requirements for risk management with a special emphasis on US Food and Drug Administration and ISO 14971 compliance. More >>

European Update

  • Czech Republic transposes Directive 2007/47/EC
  • Estonia referred to European Court of Justice
  • Commission opens public consultation on revision of IVD Directive
  • Status of tampons containing lactic acid-producing bacteria
  • Commission publishes MEDDEV 2.4/1 Revision 9 on classification
  • Manual on borderline and classification issues updated
  • EMA/Commission draft guidance on ATMPs containing a device
  • Proposed revision of the biocides regulation
  • Eucomed publishes revised GDP Position Paper
  • France updates recommendations for safe use of lifting devices
  • Greece fails to comply with court ruling on acquisition of medical equipment
  • Proposed Irish legislation to regulate device distributors
  • Update on repeal of Italian Repertorio registration fee
  • Spain reneges on prescription medical devices agreement
  • Amendments to Swiss MPG effective 1 July 2010
  • Swiss guidance on surveillance of sterilisation procedures updated
  • UK guidance on cardiac ablation catheters’ vigilance systems
  • Medical Device Alerts from the UK MHRA

More >>

US Update

  • Healthcare reform: tax on device manufacturers
  • FDA changes process for Medical Device Advisory Committees
  • Dental devices: technical amendment and Advisory Panel meeting
  • Submission of information on paediatric subpopulations
  • FDA plans to regulate laboratory developed tests as devices
  • Guidance on intravascular stents and associated delivery systems
  • Question and answer guidance on IVD device studies
  • Guidance on Humanitarian Device Exemption regulation
  • Draft guidance on voluntary audit report submission programme
  • Draft guidance on reducing risks associated with infusion pumps

More >>

International Update

  • Restructuring of the Australian TGA
  • Amendments to Therapeutic Goods Act 1989
  • Australian TGA fees & charges for 2010/11
  • ‘Excluded purposes’ for self-testing IVDs in Australia
  • Therapeutic goods that are not medical devices in Australia
  • New Advisory Committee on Medical Devices in Australia
  • Australian guidance on declarations for systems/procedure packs
  • Australian regulatory guidelines for medical devices published
  • TGA consults on advertising arrangements for therapeutic goods
  • Australian government: promotion of therapeutic products
  • Canadian classification of patient management software
  • Canada postpones adoption of STED for Class III/IV device approvals
  • GHTF guidance on Quality Management Systems adopted in Canada
  • Regulatory changes taking place in China
  • Egypt drafts new device regulations aligned with EU amending legislation
  • India to enact law to regulate medical devices
  • GS1 barcodes mandatory on all government-purchased devices in India
  • India drafts checklist of documents for importing non-critical IVDs
  • China/Hong Kong sign regulatory co-operation agreement
  • AdvaMed/Eucomed sign statement on ethical interactions
  • Japan/Singapore sign Memorandum on Information Exchange
  • Korea/Singapore sign Memorandum of Understanding
  • Libya/USA sign Trade and Investment Framework
  • AAMI relocates
  • GHTF documents
  • Expansion of Universal Medical Device Nomenclature System
  • Proposed revisions of review and approval processes in Korea
  • New Zealand restructures Ministry of Health
  • New Zealand clarifies classification of electronic cigarettes
  • Philippines to renew automatically Licences to Operate
  • Singapore publishes new regulatory guidance documents
  • Tanzania bans imports of certain disposable syringes
  • UAE: ban on sale of devices containing mercury

More >>

Environment Update

  • EU Parliamentary Committee supports changes to WEEE Directive

More >>

Standards Update

  • Vote on European phthalate standard expected in July 2010
  • Harmonised EU standards
  • Uganda drafts standards on single-use medical examination gloves
  • Modifications to the list of US FDA-recognised standards

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: South Korea
  • Elemental essentials: REACH

More >>