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Journal of Medical Device Regulation Issue Headlines - May 2011

Revamping the 510(k) Process: How the Implementation of the US FDA’s Recent Initiatives to Improve the 510(k) Programme Could Impact Your Business

Danielle C Woodlee and Lina R Kontos describe the history and development of the FDA’s 510(k) pre-market notification pathway before examining the recent scrutiny of the 510(k) process, the FDA’s recently-announced plan of action for improving the 510(k) programme in 2011, and how these initiatives are likely to impact the medical device industry. The authors also provide practical solutions for helping to minimise problems associated with following the 510(k) pathway. More >>

Regulatory Requirements for the Labelling of IVDs in Europe

Anne Van Nerom summarises the regulatory requirements for the labelling of in vitro diagnostic medical devices in Europe by focusing on four main areas: the intended purpose of the device; the language requirements; the Essential Requirements with regard to labelling; and the guidance document with regard to electronic labelling. More >>

A Confusing Lack of Regulatory Provisions for Own-Brand Labelling of Medical Devices in Europe

The ever-expanding popularity of own-brand (private) labelling as a means of acquiring exclusivity and reducing costs across numerous industries is also evident quite prodigiously in the medical device industry. For instance, the ease by which manufacturers can affix the CE mark of conformity might appear consonant with the concept of free movement of goods but actually undermines regulation, satisfactory quality, safety and performance. No regulations on the own-brand labelling of medical devices exist in the European Union, which is the essence of the problem elucidated by Haroon Atchia. More >>

Letter to the Editor - Setting the Record Straight: the Debate over Reprocessing Should Focus on Facts and Science, Not Scare Tactics and Innuendo

In the February 2011 edition of the Journal of Medical Device Regulation, Peter Schroeer wrote an article entitled Reprocessing Single-Use Medical Devices: A Risky Business. The Association of Medical Device Reprocessors (AMDR), the trade association representing third-party reprocessors in the USA, disputes many of the claims raised in this article and so the AMDR’s President, Daniel J Vukelich, has written a response in the form of a Letter to the Editor to ‘set the record straight’. More >>

European Update

  • Czech State Institute for Drug Control to improve efficiency
  • New strategy for Danish Medicines Agency in 2011-2016
  • New rules for registration of Class I devices in Denmark
  • Danish Medicines Agency to perform GLP inspections
  • Reorganisation of DG SANCO
  • Proposed patent reform not compatible with EU law
  • Responses to consultation on revision of IVD Directive
  • Guidance on clinical trials of combination products
  • Parliament adopts Cross-Border Healthcare Directive
  • European ‘Transparency Directive’ may cover medical devices
  • Manual on borderline and classification issues updated
  • New Code of Conduct for European Notified Bodies
  • NBOG meeting report
  • Finland publishes three new device Orders
  • Italy: removal of devices containing ammonium nitrate
  • Products incorrectly marketed as medical devices in Italy
  • Irish Medicines Board publishes guide to fees for 2011
  • Spain clarifies regulations for marketing of disinfectants
  • Swiss clarify regulations for marketing of disinfectants
  • UK seeks comments on electronic instructions for use
  • UK issues Device Alert for breast implants
  • Reporting adverse incidents and disseminating Device Alerts

More >>

US Update

  • FDA requests US$4.3 billion for FY 2012
  • CDRH strategic priorities for 2011
  • New device tax: Bills to repeal tax; implementation issues
  • Industry supports new R&D tax policy
  • CDRH sets up new Center Science Council
  • Classification of haemorrhoid prevention pressure wedge
  • Classification of contact cooling systems for aesthetic use
  • Classification of low level laser systems for aesthetic use
  • Ovarian adnexal mass assessment score test systems
  • Reclassification of medical device data systems
  • Disqualification of a clinical investigator: proposed changes
  • Clarifying edits to FDA’s special controls guidance documents
  • Guidance on clinical investigations of urinary incontinence devices
  • Guidance on exception from informed consent in emergencies
  • Guidance on manufacturing method and process changes
  • Guidance on requests for designation
  • Draft guidance on medical gloves that use powder
  • FDA to develop guidance for mobile medical applications
  • Medical Device Innovation Initiative launched
  • Clarification on submission of medical device malfunction reports
  • Safety Alert over use of denture adhesives
  • How to expedite the import entry review process
  • US organisations endorse guidelines for sterilisation process
  • Proposal for on-line labelling repository and device photos

More >>

International Update

  • ANMAT fees
  • Argentina extends transitional re-registration deadlines
  • Measures to prevent counterfeiting introduced in Argentina
  • TGA makes changes to annual charges and LVT for 2011-12
  • Improved search functions on the Australian Register of Therapeutic Goods
  • Australian TGA continues to release information on IVDs
  • Advertisements for CPAP or PAP units in Australia
  • Reforms to Australian device regulatory framework: consultation feedback
  • Australian TGA transparency review extended
  • Brazil revises requirements for needles, syringes and catheters
  • Brazil consults on requirements for field safety corrective actions
  • Controls for suppliers’ Declaration of Conformity proposed in Brazil
  • Fee increases for medical devices in Canada
  • Changes to establishment licensing in Canada
  • Minor amendment to Canadian Medical Devices Regulations
  • Canadian guidance on problem reporting for medical devices
  • Health Canada issues guidance on ‘significant change’
  • Guidance on private labelling released by Health Canada
  • China publishes QMS regulations
  • Egypt modifies requirements for registration of medical devices
  • Pricing control of India’s regulated medical devices
  • Co-operation agreements to strengthen health surveillance in Mercosur
  • Brazil and China agree to strengthen health surveillance
  • End of the Global Harmonisation Task Force
  • GHTF guidance on medical device regulatory model
  • EU/South Korea Free Trade Agreement
  • USA/Colombia trade agreement
  • Kyrgyz Republic drafts law on safety of medical implants
  • Malaysia to introduce device bill to Parliament
  • Marketing authorisation system launched in Saudi Arabia
  • Saudi Arabia publishes five guidance documents
  • South Africa to create Office of Health Standards Compliance
  • Thailand to improve domestic quality control standards

More >>

Environment Update

  • Brazil to align with European WEEE and RoHS requirements
  • Canada to control mercury-containing products
  • Costa Rica plans to regulate hazardous chemicals
  • Six dangerous chemical substances to be phased out by the EU
  • European RoHS Directive update
  • Proposed revisions to European WEEE targets
  • Modifications made to European CLP regulation

More >>

Standards Update

  • Czech Republic drafts technical requirements for measuring devices
  • European Commission formally objects to ISO 14971
  • Harmonised EU standards
  • International clinical practice standard for medical devices revised
  • Saudi Arabia to adopt medical electrical equipment standards
  • Modifications to the list of US FDA-regulated standards

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: Portugal
  • Elemental Essentials: EUDAMED

More >>