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Journal of Medical Device Regulation Issue Headlines - May 2010

Interview with Tanya Vogt of SAMED

The Journal of Medical Device Regulation speaks exclusively to Tanya Vogt, Chief Operating Officer of the South African Medical Device Industry Association (SAMED) about the role of the Association and the new medical device/IVD regulatory controls being implemented in the country. More >>

The Regulation of Software for Medical Devices in Europe

In this article, Dr Mathias Klümper and Erik Vollebregt summarise the amended requirements for the CE marking and conformity assessment of software resulting from the implementation of Directive 2007/47/EC. The authors additionally provide practical advice on the applicable standards, as well as answers to frequently asked questions from the medical devices industry, including how to comply with the new rules. More >>

The Urgent Need for Separate Regulatory Control of Medical Devices in India

The importance of the medical device industry, both globally and in India, should not be under-estimated. According to Kaushik Anand, Dr Kulwant Saini and B K Singh, such an important industry deserves recognition in India through the introduction of a regulatory authority and regulatory controls that are separate from those for pharmaceuticals. To support this statement, the authors start by describing the regulatory framework for medical devices that currently exists in India. The authors then compare the medical device industry with the pharmaceutical industry, discuss why regulating devices as pharmaceuticals is inappropriate, and finally examine the proposals that have been made to improve the regulation of medical devices in India. More >>

Examination of the Commission’s Services’ Interpretative Documents Affecting Dual Purpose Products

The European Commission’s Services has published three new Interpretative Documents affecting dual purpose medical device/machinery and medical device/PPE products. Haroon Atchia critically examines these guidance documents and reveals a number of illogical and contradictory statements which, if followed, could pose legal problems for device manufacturers. More >>

European Update

  • New structure for Croatia’s Devices Agency
  • Changes to Denmark’s Order on Medical Devices
  • Clinical testing of devices in Denmark
  • Parliament approves new European Commission
  • Exploratory process on future of device sector concludes
  • Public consultation on draft radiation protection document
  • New needlestick prevention legislation adopted in Europe
  • Use of EUDAMED database to become mandatory in 2011
  • SCENIHR adopts opinion on reprocessing SUDs
  • Notified Body Operations Group update
  • Germany’s health reform proposals expected mid-2010
  • BVMed rejects mandatory approval for clinical trials
  • Irish Medicines Board updates guidance documents
  • Italy transposes Directive 2007/47/EC
  • Italy’s 100 Euro fee not yet lifted from Repertorio
  • Poland proposes new device law
  • New requirements for distributors and manufacturers in Portugal
  • Prescription medical devices excluded from Spanish Law 4/2010
  • Spain develops on-line communication tool for marketed devices
  • Switzerland amends MepV and VKlin
  • Medical Device Alerts in the UK
  • Reporting adverse incidents and disseminating Device Alerts
  • Management and use of IVD point of care test devices
  • UK drafts guidance on cardiac ablation catheters’ vigilance systems

More >>

US Update

  • Obama signs landmark health reform bill
  • Budget requests for fiscal year 2011
  • FDA Improvement Act of 2010 introduced
  • Submission of information on paediatric subpopulations
  • Device registration and listing requirements to be amended
  • Neurological and physical medicine devices: proposed designation
  • Guidance on the use of Bayesian statistics in clinical trials
  • Draft revised guidance on transparency and Advisory Committees
  • Medical device technical amendments
  • CDRH launches medical device and radiation-emitting product website
  • FDA unveils new home use initiative

More >>

International Update

  • Australia’s IVD regulations
  • Amendments to Therapeutic Goods Act 1989
  • Australia to reform health technology assessment
  • Australia creates device-specific clinical investigation agreement
  • Deadline reminder: Brazil to require GMP certificates from 22 May 2010
  • Health Canada proposes user fee increases
  • Units of measurement for blood glucose meters sold in Canada
  • Canada develops template for reusable medical device IFU
  • China seeks comments on draft provisions for device recalls
  • Hong Kong issues draft guidance on listing LRPs under MDACS
  • Indian guidelines on compensation for medical researchers
  • AdvaMed and Eucomed discuss areas of collaboration
  • AHWP Working Group updates
  • India/USA sign framework for co-operation on trade and investment
  • Non-corrective contact lenses regulated as devices in Japan
  • New Russian device law being drafted
  • Marketing authorisation to start in Saudi Arabia in September 2010
  • Saudi Arabia blocks imports of improperly stored devices
  • Singapore implements final phase of device regulatory framework
  • Thailand publishes laws to supplement Medical Device Act

More >>

Environment Update

  • European Parliament to debate recasts of WEEE/RoHS Directives
  • US proposed rule on air shipment of lithium batteries

More >>

Standards Update

  • Brazil drafts standards on syringes, medical gloves and infusion sets
  • Canada proposes changes to list of recognised standards
  • China opens management centre for medical device standards
  • Czech Republic drafts technical requirements for tonometers
  • Czech Republic drafts requirements for electronic thermometers
  • Revision of European standardisation system
  • European and Chinese standards posted on on-line platform
  • New ISO standard for safer use of symbols with medical devices
  • Israel modifies standard for single-use hypodermic needles
  • Delayed entry into force of Israel’s medical electrical equipment standard
  • Korea proposes revision of standards
  • Mongolia seeks comments on labelling of imported measuring instruments
  • USA to formally recognise electrical equipment standard
  • New AAMI report details guidance on EtO sterilisation process

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: Algeria
  • Elemental essentials: European Standards Organisations

More >>