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Browse English Issue Headlines - May 2005

Delay for Joint 'Trans-Tasman' Therapeutic Products Agency

The Australian and New Zealand Joint Therapeutic Products Agency (JTA) was due to open its doors for business on 1 July this year. On Thursday 10 February 2005, the Australian Parliamentary Secretary for Health announced that the JTA, which is scheduled to replace the Australian Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe), would not open its doors on 1 July 2005 as planned but would begin operation on 1 July 2006 instead. Jennifer A Svec discusses the implications of this delay, which has come as something of a surprise to both industry and the primary industry bodies. More >>

Clinical Investigations: Europe, the US & Japan

When developing a medical device, any manufacturer is faced with the critical regulatory need for clinical data in order to safely put a device on the market. The need is even more critical when it concerns high-risk devices where the requirement for future clinical investigations is more and more likely in all continents of the world. Different regulatory systems do not make the planning of such prospective clinical investigations easy. However, according to Danielle Giroud, if planning is performed well in advance, significant time and money can be saved when bringing a device to the market. More >>

Device Regulation & the Harmonisation Process In Latin America

Latin America is an important region for the medical devices consumer market, particularly with regard to imported products, as there are few local industries working with cutting-edge technology. For medical devices, Latin America offers certain challenges to companies, particularly foreign corporations, wishing to build up a presence in the various countries in this region. Eliana Silva de Moraes explains that this is because there are many different procedures and regulations to be followed when gaining approval for medical devices due to the autonomy of the Latin American nations and the lack of international pacts among them in this sector. In her article she provides more detailed information about the requirements in Brazil, Argentina, Venezuela, Mexico and Chile. More >>

The Need for European Needlestick Legislation

There are between 350,000 and 800,000 healthcare workers injured with needlesticks and other sharps injuries in the USA each year. But this is far from being a US problem only. The estimated number of sharps injuries each year in the UK is 100,000 and Scotland is 4000. Over 500,000 needlestick injuries occur a year in Germany. It is estimated that healthcare workers in Europe suffer one million needlestick injuries each year, of which 40% relate to nurses. The World Health Organisation estimates that globally there are three million accidental needlestick injuries annually. Ron Stoker reviews the current legislative situation for needlesticks in the US, which could provide a useful framework for needlestick legislation in other countries including the UK and the rest of the EU. More >>

European Update

  • Czech sterilisation guideline published
  • Labelling in Denmark
  • Electronic labelling in Europe
  • European/Australian Mutual Recognition Agreement
  • Commission's clarification on IVDs manufactured in-house
  • Data protection and intellectual property rights
  • Tooth whitening products
  • AFSSaPS view on interactions between AIMDs and medical devices
  • High risk devices in France
  • BfArM issues information on safe use of infusion pumps
  • Gynaecological ultrasonic probes used in Germany
  • BVMed Annual Report 2004/5 published
  • Devices containing tissues of animal origin in Portugal
  • Swissmedic's new postal address
  • Swiss requirements for distributors: an overview
  • Relocation of UK MHRA staff
  • Medical Device Alerts issued by the UK MHRA
  • UK MHRA viewpoint on tissue engineering and nanotechnology

More >>

US Update

  • Medical device reporting requirements
  • Immunology and microbiology devices: classification
  • Instrumentation for clinical multiplex test systems: classification
  • DME genotyping test systems: classification
  • Haematology and pathology devices: proposed reclassification
  • MDUFMA user fee programme in 2005
  • STED pilot programme extended
  • Guidance on application user fees for combination products
  • Combination product dispute resolution guidance document published
  • Guidance on 510(k)s for intravascular administration sets
  • CPG for sphygmomanometers

More >>

International

  • Australia/US Free Trade Agreement
  • Safety Alert re-issued for guidewires
  • Australian TGA fact sheets: suspension/cancellation of a device entry in the ARTG; disinfectants; re-manufacturing single use medical devices
  • Chinese GMP requirements for radio-immunoassay kits
  • Chinese guide on operational practice for medical device testing
  • Medical device regulatory priorities for China in 2005
  • China and Hong Kong trade agreement
  • GHTF SG2's achievements and current work
  • MoU between Australia and Canada
  • ISRM becomes affiliate member of CENELEC
  • Kenya and Former Yugoslav Republic of Macedonia join IEC
  • IEC and ILAC sign Memorandum of Understanding
  • Japanese GMP regulations
  • Reimbursement in Korea: an overview
  • Fast track product registration in Taiwan

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Environment Update

  • Packaging and packaging waste: amendments to Directive 94/62/EC; formats for the database system; harmonised standards
  • Regulated substances in electrotechnical products

More >>

Standards Update

  • Electromedical equipment
  • IEC/AMN co-operation agreement
  • Device cleaning and sterilisation
  • Medical device software risk management

More >>

Reference Information

  • Meeting report: medical devices vigilance - revision of MEDDEV 2.12/1
  • Elemental Essentials: Global Medical Device Nomenclature
  • South American regulatory authorities contact details chart
  • Language requirements for labels and Instructions for Use in the EU
  • Book review: ‘Six Sigma for Medical Device Design'
  • Letter to the Editor: CE marking

More >>