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Journal of Medical Device Regulation Issue Headlines - February 2009

Medicinal Product and Medical Device Borderline: Exploring the Scope and Application of the EU Directives

John Deavin analyses the definitions of a medicinal product and a medical device as set forth in the European Directives and considers the European Commission guidance document MEDDEV 2.1/3 rev 2, with its texts on the demarcation between the Medical Device Directive and the Medicinal Products Directive. He also assesses whether these documents are properly aligned in order to create a consistent regulatory framework spanning all product categories. More >>

Understanding Software Development from a Regulatory Viewpoint

From a conventional engineering standpoint, software is a difficult concept to grasp. As an intangible it exists largely in the imagination of the developer and is only evident to the layman from the influence it has over tangible programmable devices. Blake Greenís article attempts to demystify software and its equally mysterious relative firmware before discussing regulatory implications for manufacturers of stand-alone software, applications software, operating systems software, and firmware applied to human medicine. More >>

Regulatory Approvals of IVDs in Japan

With 10% of the global market share, clearly defined requirements, and a demand for better preventative and diagnostic healthcare, Japan is an ideal target market for foreign device manufacturers. In this article, Kazuya Hijii, Seiko Ohyama and Tara Kambeitz outline the process for obtaining marketing approval for in vitro diagnostic medical devices (IVDs) in Japan. More >>

HTA in Central and Eastern Europe: Current Status, Challenges and Opportunities

Significant changes and advancements in Central and Eastern European (CEE) countries, including increases in life expectancy, changes in chronic disease prevalence, and healthcare spending, call for an approach focused on obtaining value for money. Notable strides have been made in the CEE countries to meet this need through the introduction and support of health technology assessment (HTA). Some countries, such as Hungary and Poland, have more formal HTA systems in place, while others (e.g. Romania and Slovenia) are still in the early stages of implementing a national body(s). Given experiences to date, this article by Corinna Sorenson, Panos Kanavos and Manolis Karamalis identifies several challenges and opportunities to the continued development and success of HTA in the region. Challenges include a lack of qualified personnel and funds to conduct assessments as well as a relative lack of educational and training opportunities; setting assessment priorities, given limited capacity and resources; poor data availability in the region, including data on health status, outcomes and costs; and how to ensure the application of HTA in decision-making and the implementation of national decisions and guidance. HTA in the region also presents opportunities, however. Countries can capitalise on the lessons learned from more established international HTA systems and adopt successful strategies implemented by these countries, where appropriate; in addition, they can introduce expedited assessment processes for conducting HTAs. More >>

European Update

  • Czech reimbursement costs
  • Denmark increases fee for clinical trial applications
  • MEDDEVs on clinical data and clinical investigations
  • Proposed improvements to European CTSs for IVDs
  • Commission adopts Communication on telemedicine
  • Europeís pilot pre-adoption screening programme
  • France abolishes clinical trial application fees
  • German Parliament passes Hospital Financing Reform Act
  • German DRG Catalogue for 2009 published
  • Irish Medicines Board to be restructured
  • Irish Medicines Board fees
  • Irish guidance on online vigilance reporting system
  • Italy extends deadline for registration
  • UK Device Alert on adverse incident reporting
  • UK MHRA drafts guidance on vigilance systems
  • New contract agreement for medical technology trials in the UK

More >>

US Update

  • Class II classification of enterovirus nucleic acid assay
  • Designation of special control for natural rubber latex condoms
  • Class II classification of tissue expanders is proposed
  • Consumer Product Safety Improvement Act of 2008 Ė update
  • Guidance on Good Reprint Practices published
  • Guidance on the PMA Supplement decision-making process
  • Guidance on safe use of hand-held x-ray equipment
  • Guidance on clinical data retention
  • ST79 steam sterilisation guidance updated
  • AAMI publishes revision of TIR 17 sterilisation guidance
  • Draft guidance on 510(k) submissions for sterile devices
  • Draft guidance on assay migration studies for IVDs
  • Draft guidance on Good Importer Practices
  • FDA opens offices in China, India and Latin America
  • Investigation launched into allegations of corruption in the CDRH
  • Massachusetts proposes new rules on sales and marketing
  • Minnesota proposes extending medical disclosure law to devices
  • GAO report highlights deficiencies in high-risk device approval process
  • Safety advice on transvaginal placement of surgical mesh

More >>

International Update

  • Argentina amends clinical trial requirements
  • Proposed amendments to Australian Therapeutic Goods Act 1989
  • Application audit process changes in Australia
  • Four Standards Orders are registered in the FRLI
  • Draft Australian guidance on regulation of custom-made devices
  • Consultation on use of third-party CABs in Australia
  • Code of Practice for tamper-evident packaging under review
  • Australia continues consultation on ARGMD
  • Review of Australian HTA procedures
  • China strengthens controls on exported devices
  • SFDA issues requirements for adverse event monitoring
  • China standardises labelling and packaging requirements for imported devices
  • Tighter controls to be placed on clinical trials in India
  • India proposes ISO quality certification for medical devices
  • GHTF
  • Bahrain, Kuwait and UAE draft general product safety regulations
  • Europe and Cameroon sign trade agreement
  • Singapore signs MoUs on health products regulation
  • US CAFTA-DR for Costa Rica implemented
  • US/Oman FTA enters into force
  • Office of International Programs established by Japanís PMDA
  • Japanís MHLW requests increased funding for devices
  • Japan publishes revisions to GCP standards
  • Non-corrective contact lenses to be regulated as devices in Japan
  • Japan adopts five-year action plan
  • Report on Japanís progress in reducing approval times
  • Korea proposes regulation on HUDs
  • New device notification database being developed in New Zealand
  • Saudi Arabia plans to implement interim market access rules
  • UAE drafts conformity assessment procedure

More >>

Environment Update

  • Proposed revision of WEEE and RoHS Directives
  • Europe bans export of metallic mercury
  • Batteries and accumulators in Europe
  • Opinions sought from European Scientific Committees
  • Chemicals classification, labelling and packaging
  • Italy: position on measuring devices containing mercury clarified
  • Spain transposes REACH Regulation
  • US tightens regulatory controls on mercury-containing products

More >>

Standards Update

  • China drafts standards on IV needles and ultrasonic diagnostics
  • CEN/CENELEC offices have relocated
  • CEN/CENELEC collaborate on information and communication
  • Harmonised EU standards
  • Mexican NMX standards required for all government purchases
  • ANSI/AAMI to publish revised ethylene oxide standard
  • NEMA publishes three diagnostic MRI standards

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: Greece
  • Elemental essentials: sensitivity and specificity
  • Essential Principles of safety and efficacy: GHTF, EU, Canada, Australia, and the USA

More >>