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Journal of Medical Device Regulation Issue Headlines - November 2009

Interview with Dr Larry Kelly, Head, Office of Devices, Blood and Tissues, Australian TGA

Susan Alder speaks to Dr Larry Kelly, Head of the Office of Devices, Blood and Tissues at the Therapeutic Goods Administration in Australia about the recent changes to the medical devices’ legislation, as well as implementation of the new regulatory framework for in vitro diagnostic medical devices. More >>

Problems of Implementing ISO 14971

The standard for risk management has, until now, been the source of under-application and misunderstanding. Efforts to reinforce the concepts of the New Approach Technical Directives for risk-proportion in regulation, especially for medical devices, have culminated in the publication of increasingly complex and demanding editions of the standard. Haroon Atchia’s article explores the changing demands of the standard, illustrates the evolution of its content, and reiterates the standard’s practical utility for the medical device sector. The article also examines the obligations to consider risk during the post-production phase and use error, which were introduced by the 2007 edition of the standard. More >>

Protecting Medical Devices from the Effects of Moisture

Moisture is an ever-present in air. It is capable, if left uncontrolled, of causing significant problems with many medical devices. For example, in vitro diagnostic test strips with testing chemicals that are moisture sensitive must be protected if they are to give accurate and reliable test results, whilst devices with electronic components must be protected to prevent corrosion and malfunction. In this article, Dr Ian Buckley investigates the sources of moisture, the effects moisture can have on devices, and the use of desiccants in protecting medical devices. More >>

How the Revised MDD will Affect Notified Body Audits

Directive 2007/47/EC was published in the Official Journal of the European Union on 21 September 2007 and Members States had to transpose the Directive into national law by 21 December 2008, although many have still not completed that obligation. From 21 March 2010, the revised Medical Device Directive will apply and all manufacturers must fully comply or have fully complied if CE marked devices are being placed on the market in Europe. Françoise Schlemmer and Chris Jepson examine the expected changes to the Notified Body audit process and explain what might happen before, during and after an audit. More >>

European Update

  • Commission revises two interpretative documents
  • Commission seeks to identify challenges facing device industry
  • Finland’s medical device regulatory activities transfer to Valvira
  • Certain revisions of German Medical Devices Act implemented
  • BVMed prepares 10-point plan for medical technology in Germany
  • Irish Medicines Board proposes fee structure for 2010
  • Spain adopts new medical device regulation
  • Spain revises common technical specifications for IVDs
  • UK MHRA issues draft guidance on vigilance systems

More >>

US Update

  • Medical device user fees for FY 2010
  • FDA’s FY 2010 budget invests in medical product safety
  • Device industry opposes proposed tax in health bill
  • Final rule on classification of dental devices
  • Respiratory viral panel multiplex nucleic acid assay: classification
  • Classification of wound dressings with pDADMAC additive
  • HSV types 1 and 2 serological assays: reclassification
  • Proposed mandatory electronic safety reporting
  • Combination products: cGMP and post-market surveillance
  • Guidance on user fees and refunds for 510(k)s
  • Guidance on third party accreditation criteria
  • Guidance on AST systems
  • Guidance on establishment registration and device listing
  • Draft guidance issued on IVDs for HPV detection
  • Guidance drafted on surgical ablation devices for AF treatment
  • Updated guidance on MQSA Regulations drafted for comment
  • Post-market surveillance studies on certain spinal systems
  • FDA Commissioner’s vision for improving enforcement
  • Suitability of 510(k) review process to be examined by IOM
  • OIG to assess adequacy of FDA’s complaint investigation process
  • Public Health Notification on GDH-PQQ glucose test strips
  • Comments requested on safety & effectiveness of ECT devices

More >>

International Update

  • Argentina establishes transitional re-registration scheme
  • Amendments to Australian Therapeutic Goods Act 1989
  • TGA extends deadline for LVT exemption applications
  • Changes to Australian regulations for change of sponsor
  • New Australian regulations on issuing infringement notices
  • Consent for non-compliance with Australian Essential Principles
  • TGA to amend definition of custom-made devices
  • Australia’s draft ARGMD compendium circulated for comment
  • Brazil consolidates and strengthens post-market surveillance
  • Classification of patient management software in Canada
  • Canada to adopt STED for Class III/IV device approvals
  • Health Canada’s application requirements for combination products
  • Health Canada drafts guidance on classifying IVDs
  • China specifies registration procedure in emergency situations
  • Medical room air sterilisation equipment in China
  • Hong Kong issues safety advice on endoscopy/laparoscopy instruments
  • CDSCO in India publishes initiatives for 2008-2012
  • GHTF documents
  • Recent regulatory changes in Mexico
  • Device notification database launched in New Zealand
  • Philippines’ new FDA to have greater regulatory powers
  • Singapore issues draft medical device guidance documents
  • SAMED members must adopt new code of marketing
  • Tanzania extends deadline for submitting information on imported devices

More >>

Environment Update

  • Batteries and accumulators
  • Use of cadmium in electric and electronic equipment

More >>

Standards Update

  • Database of device standards created
  • IEC publishes technical report on risk management for device software
  • Korea proposes revisions of standards for devices
  • Mexico cancels numerous device standards
  • Modifications to the list of US FDA-recognised standards
  • FDA asks ISO to tighten requirements for home-glucose monitors
  • Revised standard offers guidance on in vitro cytotoxicity testing

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: Denmark
  • Elemental Essentials: European Authorised Representatives
  • Risk management techniques

More >>