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Journal of Medical Device Regulation Issue Headlines - February 2008

Fifteen Years of Collaboration: The Global Harmonization Task Force

As the Global Harmonization Task Force (GHTF) celebrates its 15th year, it seems an appropriate time to take stock of its accomplishments and look to the future. In this editorial, Larry Kessler provides a brief background of the GHTF, notes some of its most important accomplishments, and describes the actions that the GHTF is taking to make harmonisation a reality in the future. More >>

Five-Year Vision & Strategies of Canada's Medical Devices Program

Canada's regulatory programme for medical devices is strong, and Canadians can be confident that it strives to provide medical devices sold in Canada that are safe, effective and of high quality. At Health Canada, the Medical Devices Program (MDP) has a mandate to evaluate and monitor the safety, efficacy and quality of diagnostic and therapeutic medical devices, through a combination of pre-market review, post-approval surveillance and quality systems in the manufacturing process. With input from staff and stakeholders, a Strategic Plan for the MDP was recently developed that encompasses the programme’s vision and strategies for five years – from 2007 to the end of 2012. Roland Rotter and Jessica Dean review this plan, entitled Building for the Future, which is an exploration of the current and upcoming challenges the programme faces while laying out potential means of overcoming those challenges. By taking a comprehensive overview of the programme's strategic objectives, Building for the Future will allow the MDP to reinvigorate itself. More >>

Translation - a 'Must Have' Tool

The European Medical Device Directive has forced a great many medical device manufacturers to recognise the importance of languages other than English and therefore understand the value of translation in today’s marketplace. Lior Cohen's article discusses the implications of European legislation, the commercial and marketing value of translation, and the potential downside of using a distributor to undertake translation work. More >>

The FDA PMA Versus the EU CE Mark Filing and Approval Experience: An Empirical and Descriptive Analysis

This article by Ralph Jugo is devoted to performing a descriptive and statistical analysis comparing the US Food and Drug Administration premarket approval application (PMA) process to the European Union (EU) CE marking approval process. The comparison revealed a striking and noteworthy difference indicating that, on average, devices received CE mark approval 3.52 years sooner than PMA approval was received for the same devices in the USA. It was also revealed that five devices whose PMA applications were disapproved in the USA, received CE mark approval in the EU an average of 4.73 years sooner. The analyses support the overall conclusion that medical devices are approved much sooner and presumably faster in the EU, and that CE mark approval is more streamlined, less burdensome, and approval is considerably easier to obtain. More >>

New Approach Review - A New Legislative Framework for Products Supplied in the EU

In February 2007, after years of preparation, the European Commission formally presented two new proposals to harmonise the European Community’s legislation affecting the supply of products: a Regulation setting out the requirements for accreditation and market surveillance relating to the marketing of products; and a Decision on a common framework for the marketing of products. Taken together, these proposals from the Commission are designed to create a new legislative framework for those products that are subject to the Community harmonisation legislation, which regulates the supply of goods in the European Economic Area, and to simplify the framework of product legislation in Europe in the process. This article by Richard Lawson describes the content of the proposed Regulation and Decision and explains the likely impact of these changes on the medical device industry. More >>

The FDA Amendments Act of 2007 - More Than Just Medical Device User Fees

After a summer of anxiety on the part of the medical device industry and rumours of a reduction in the Food and Drug Administration workforce, H.R. 3580, the Food and Drug Administration Amendments Act (FDAAA) of 2007, passed the US House of Representatives on 19 September 2007 by a vote of 405-7, was passed unanimously by the Senate on 20 September 2007, and was signed into law by President Bush on 28 September 2007. The Medical Device User Fee provisions, commonly referred to by the medical device industry as MDUFMA II, were only a very small part of the legislation and some of the new requirements left both the regulators and the regulated industry scrambling, the regulators to implement some of the new provisions and the regulated industry to maintain compliance. Many of the new requirements will be associated with implementing regulations or guidance documents. While this legislation affects both the Agency and the regulated industry, Rosina Robinson's discussion provides an introduction to the provisions and requirements that have an impact on medical device manufacturers. More >>

European Update

  • Denmark updates its vigilance information
  • New contact details for Estonian State Agency of Medicines
  • European regulation on advanced therapies published
  • Electromagnetic fields legislation to be postponed and amended
  • Fee schedule for chemicals registration
  • Combating counterfeit medical devices in the EU
  • Proposal to suspend metric-only labelling Directive
  • Scientific Committee public consultations on dental amalgams
  • COCIR proposes international standards for device refurbishment
  • Finnish National Agency for Medicines: fees for 2008/9
  • AFSSaPS updates tracking requirements
  • French quality control requirements for scanners
  • Plans for new German Drugs and Devices Agency shelved
  • Uniform assessment standard enters into force in Germany
  • 2008 version of German DRG catalogue published
  • Irish vigilance guidance notes and forms updated
  • Sweden updates recommendations on use of drug-eluting stents
  • Regulation on disinfectants in Switzerland
  • UK reclassifies talc preparations for pleurodesis
  • MHRA’s anti-counterfeiting strategy
  • UK safety guidelines for MRI equipment in clinical use
  • UK MHRA Medical Device Alerts
  • Advice on effects of wear debris generated from hip implants

More >>

US Update

  • Legislation to update diagnostics reimbursement
  • Certification to accompany device applications or submissions
  • Haematology and pathology devices: reclassification
  • Proposed rule changes for PMA labelling amendments
  • Improvements announced to Advisory Committee processes
  • New electronic comment submission process
  • Interactive review for medical device submissions: guidance
  • Medical device tracking: guidance
  • Review and inspection of PMAs: two final guidance documents
  • IVD studies: draft guidance
  • Impact-resistant lenses: draft guidance
  • New PMA guidelines for ICD leads expected in 2008
  • Good Reprint Practices currently being drafted
  • Electric dental handpieces: public health notification
  • Cleaning electronic medical equipment: public health notification
  • Unretrieved device fragments: public health notification

More >>

International Update

  • Fee payments for inclusion in Argentinean registry
  • Australian Therapeutic Goods Manufacturing Principles
  • Comments sought on updated Australian Standards Orders
  • TGA issues safety recommendations on CPAPs/VPAPs
  • Australia’s DR4 now only applies to therapeutic devices
  • Brazil proposes new rules for exported products
  • Amendments to Canada’s Medical Devices Regulations
  • Revised Canadian guidance on ISO 13485 QMS certificates
  • Update on re-use of single-use devices in Canada
  • China indefinitely postpones device import regulation
  • Tighter control of medical product advertisements in China
  • SFDA blacklists 13 medical device companies
  • Regulatory news update from China
  • New Indian Drugs Authority to be established
  • Conformity assessment for ASEAN countries
  • US/China sign agreement to improve device safety
  • US/Peru Trade Promotion Agreement
  • New device terms to be included in MedDRA
  • GHTF guidance on auditing QMSs
  • Product counterfeiting in Israel
  • Proposed changes to device reimbursement in Japan
  • Regulatory update for Jordan
  • Regulatory update for Lebanon
  • Saudi Medical Devices Problem Reporting Centre established
  • Medical devices national registry launched in Saudi Arabia
  • Draft guidance documents issued by Singapore’s HSA

More >>

Standards Update

  • Update to Canada’s list of recognised standards
  • Harmonised EU standards
  • Standards Institution of Israel becomes CENELEC affiliate
  • Modifications to the list of US FDA recognised standards
  • New standards on biological evaluation and implantable devices

More >>

Reference Information

  • Regulatory personnel on the move
  • 12th AHWP meeting report
  • Country overview: Iran
  • Elemental Essentials: US National Institutes of Health

More >>