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Browse English Issue Headlines - May 2006

US Food and Drug Administration Centennial

On 30 June 2006, the US Food and Drug Administration is celebrating 100 years of protecting the health of Americans through a sophisticated public health system that ensures the quality of food, drugs, vaccines and medical equipment. As the Agency moves forward in the 21st century, Victoria Clark takes a look back at the origins of US medical device regulation and charts the significant milestones of the Center for Devices and Radiological Health since the Federal Food, Drug and Cosmetic Act was enacted in 1938. More >>

Changes in Clinical Risk Management & Lessons to be Learnt from the Pharmaceutical Industry

Over the last 10 years there has been an explosion of interest in the use of risk management techniques across a wide range of sectors. Although risk management is not a new concept for the medical technology industry, the development of advanced healthcare products and the changing perceptions of the public and patients with regard to safety have placed an increased emphasis on addressing clinical issues. In this editorial, Dr David Jefferys questions whether device risk management could follow the path of medicinal products, discusses the issues surrounding clinical studies and explores the need to consider having extensive clinical risk management minimisation as part of the overall risk management plan for each product. More >>

IEC 60601-1 The Third Edition

IEC 60601-1 has, over the years, become the 'bible' of electromedical equipment safety and the parent standard of over 60 device-specific standards ranging from diagnostic electrocardiographs to electron accelerators used in radiotherapy. In this article, Charles Sidebottom, Harvey Rudolph, Michael Schmidt and Leo Eisner provide a high-level overview of the significant changes contained in the third edition of IEC 60601-1 and the impact these changes will have on manufacturers and certification bodies. More >>

Is it Time for Academic Preparation of Future Regulatory Affairs Professionals?

According to a number of sources, the medical device industry and, presumably, the regulatory agencies around the world are currently experiencing a significant shortage of knowledgeable and skilled regulatory affairs professionals. The luxury of time and additional human resources to train new personnel internally are no longer available to most companies so other avenues must be explored. Rosina Robinson discusses the potential benefits of training future regulatory affairs professionals in academic institutions and urges the industry to be more proactive in educating the next generation of regulatory affairs professionals to help fill the current experience gaps. More >>

European Update

  • DMA assumes responsibility for device clinical trials
  • Commission proposes to ban mercury in fever thermometers
  • Legislative proposals adopted by the European Commission
  • Request for an opinion on DEHP-plasticised PVC on neonates
  • Eucomed comments on medical device Directive review proposal
  • Eucomed publishes flyer on differences between devices and pharmaceuticals
  • NAM Annual Report 2005 published
  • Finnish study on allergen content of medical latex gloves
  • French quality control of digital mammography installations
  • BVMed Annual Report 2005/6 published
  • German DRG system
  • Guidance on auditing by the Irish Medicines Board
  • Switzerland to introduce German-style DRG system
  • Medical Device Alert concerning cochlear implants
  • Adverse incident reporting in the UK
  • Urine dipstick tests

More >>

US Update

  • Office of Combination Products telephone number change
  • Legislation on counterfeiting
  • CDRH's postmarket transformation initiative
  • Assessment of post-marketing study commitment decision-making process
  • Cardiovascular devices: classification
  • Immunology and microbiology devices: classification
  • HAV serological assays: reclassification
  • Intervertebral body fusion device: proposed reclassification
  • Topical oxygen chamber for extremities: proposed reclassification
  • Bone sonometers: proposed reclassification
  • Medical device reporting: technical amendment
  • Guidance on hospital bed design to reduce patient entrapment
  • Guidance for industry and FDA staff on dental curing lights
  • Final guidance issued on tonometers
  • Guidance issued on IVDs used to detect influenza A viruses
  • Draft guidance on providing regulatory submissions in electronic format
  • Modifications to the list of FDA recognised standards
  • AdvaMed's proposal for pulse generator product performance reports
  • NEMA establishes a Nanotechnology Advisory Council

More >>

International

  • IVD reclassification in Argentina
  • Medical devices legislation transition period ends in October 2007
  • Australia's IVD regulatory framework
  • Draft Australian fact sheets circulated for comment
  • Questions and answers on GMP clearance in Australia
  • Changes to 'Therapeutic Goods Act 1989' for patent certification
  • Brazil places restrictions on the re-use of medical devices
  • Administrative Service Center of the Chinese SFDA
  • Manufacturing supervisory requirements issued by China's SFDA
  • Illegal medical device advertisements in China
  • Use of hydrophilic PAAG for breast augmentation in Hong Kong
  • Hong Kong issues medical device explanatory leaflet
  • India hopes to establish National Drug Authority by mid-2007
  • Import and manufacture of medical devices in India
  • Australia and New Zealand joint regulatory scheme: consultation planned for 2006/7
  • MoU between Australia and Switzerland
  • US/Colombia conclude Free Trade Agreement
  • US/Peru sign Trade Promotion Agreement
  • US/South Korea Free Trade Agreement to be negotiated
  • US/Malaysia Free Trade Agreement to be negotiated
  • Summary of US/ASEAN free trade efforts
  • Proposed elimination of global tariffs on medical devices and medicinal products
  • Global Harmonisation Task Force SG2 final documents
  • Serious eye infections associated with soft contact lenses
  • International trademark treaty adopted in Singapore
  • Nigeria and Sri Lanka join IEC as Associate Members
  • Good Vigilance Practice in Japan
  • An update on Good Laboratory Practice in Japan
  • Medical device reimbursement prices reduced
  • Devices prohibited from importation into Thailand
  • Recommendations on the importation of refurbished x-ray equipment

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: Turkey
  • Elemental Essentials: navigating the 'sea afar' the US Code of Federal Regulations
  • Clinical trial requirements in Austria
  • Conformity Assessment Procedures - Part 2: Directive 93/42/EEC

More >>