Browse English Issue Headlines - February 2012

Industry’s high expectations for the International Medical Device Regulators’ Forum (IMDRF)

The medical device industry has high expectations from the International Medical Device Regulators’ Forum (IMDRF), the new group replacing the Global Harmonization Task Force (GHTF). Industry has made progress in its regulatory practices with the efforts of the GHTF to harmonise systems in the regulation of medical devices but it is uncertain of the impact the IMDRF will make. In anticipation of the inaugural meeting of the IMDRF taking place in Singapore from 28 February to 1 March 2012 under the leadership of Australia, a recent survey has shown that the medical device industry expects much more from the IMDRF than its predecessor, the GHTF. This article by Gabriel Adusei brings to light some of industry’s expectations for the work of the IMDRF. More >>

How will the European Directive ‘RoHS 2’ impact the medical device industry?

The European Directive on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS Directive) has been recast and superseded by a new Directive published in July 2011. ‘RoHS 2’, as the recast Directive has become known, will no longer exclude medical devices. After 22 July 2014, all medical devices meeting the definition of electrical and electronic equipment will be restricted at a homogenous level from using lead, mercury, cadmium, hexavalent chromium, and two polybrominated flame retardants. There is an extended transition period for in vitro diagnostics (until 22 July 2016) and continued exclusion for active implantable medical devices. James Calder looks at what a company should consider to ensure its medical devices are in compliance by the deadline and may continue to be marketed in the European Union after July 2014. More >>

Regulation of IVDs in Australia – the first 12 months

On 1 July 2010, the Australian therapeutic goods legislation was amended to require the inclusion of all in vitro diagnostics (IVDs) in the Australian Register of Therapeutic Goods. Prior to this date, most IVDs had been exempt from this requirement, which meant that products could be marketed in Australia with minimal or in most cases no requirement for evaluation by the Therapeutic Goods Administration. Details of the regulatory process were set out in the August 2009 issue of the Journal of Medical Device Regulation. This new article by Susan Alder focuses on industry’s experience following the first 12 months of the new legislation, which has had a very significant impact on the IVD industry. More >>

South America for beginners - How to advise your company on country priorities for product placement

Large, global medical device companies usually have many different products in their portfolios that they market all over the world with the help of subsidiaries and on-site experts. This structure provides a simple and efficient way of keeping up-to-date with potential changes in local requirements and legislations. However, this avenue is not open to many smaller companies. Dr Susana de Azevedo Wäsch discusses what a small medical device company should consider when it intends to explore new markets in South America, with their differing markets, cultures and regulations. More >>

US FDA medical device user fee update

The medical device user fee programme in the USA will expire (sunset) on 30 September 2012 unless formally reauthorised by legislation. The Food and Drug Administration (FDA) was required to propose its recommendations for the new legislation to the US Congress by 15 January 2012. While recent activities in the US medical device arena may be making the required negotiations an interesting spectator sport, there are concerns that the recent adversarial relationship between industry and the Agency may prevent meaningful review process improvements that could benefit both groups. The summary provided by Rosina Robinson reviews the FDA’s medical device user fee programme to date and provides food for thought on the reauthorisation process. More >>

European Update

  • Bulgaria publishes updated fees for medical equipment
  • Czech Republic reiterates rules for notifying adverse events
  • Denmark updates fee charges for medical equipment
  • Commission roadmap for 2012: Directives will become Regulations; role of MDEG to change
  • vCJD assays added to Directive 98/79/EC List A; CTSs drawn up
  • MEDDEV 2.12/2 on post-market clinical follow-up updated
  • Commission issues common definition for ‘nanomaterial’
  • SCENIHR opinion sought on safety of bisphenol A in devices
  • EDMA and Eucomed to establish European industry federation
  • COCIR’s position on privacy and protection of health data
  • Eucomed sets out proposals for improving European device legislation
  • France adopts healthcare reform law
  • BVMed updates guide on clinical evaluations in Germany
  • Sweden clarifies manufacturers’ reporting responsibilities
  • Switzerland: identification of manufacturers on medical devices
  • UK reissues Device Bulletin on reusing single-use devices

More >>

US Update

  • Legislation to clarify FDA’s mission introduced to Senate
  • Bill to improve device approval process introduced to Senate
  • Post-market studies and recalls covered by new Senate Bill
  • Senate Bill to streamline de novo classification process
  • Bill to repeal new device tax gains support
  • House Committee members introduce FDA reform package
  • Classification of IVDs for Yersinia species detection
  • Ovarian adnexal mass assessment score test systems
  • IDEs for early feasibility medical device clinical studies
  • Guidance issued on IVDs for HPV detection
  • Enforcement policy for some diagnostic and radiology devices
  • Products intended to repair/replace knee cartilage: guidance
  • Scientific exchange on off-label uses; unsolicited requests for off-label information
  • Artificial pancreas system clinical trials and product approvals: draft guidance
  • Draft guidance: contemporary perspective on 510(k) process
  • CDRH appeals: draft guidance clarifies available processes
  • Draft guidance on HUD designations
  • Draft guidance on medical device classification product codes
  • Draft guidance on FDA decisions for IDEs
  • Draft guidance to improve representation of women in clinical studies
  • FDA finds gaps in medical device quality

More >>


  • Argentina establishes post-market vigilance programme for dental devices
  • Australian TGA releases blueprint for future
  • New Australian guideline on reduction of device assessment fees
  • New rules for IVDs to be introduced in Brazil from May 2012
  • Brazil tightens controls on medical gloves
  • Brazil consults on use of electronic IFUs
  • Canadian Medical Device Bureau relocates
  • Canada now requires Class III applications in electronic format
  • QMS certificate provisions of Canadian device regulations
  • Hearing process for suspension of a device licence by Health Canada
  • Canadian guidance on HIV test kits used in laboratories
  • Revised Canadian guidance on representation of women in clinical trials
  • Ontario implements changes to Product Safety Regulation
  • China publishes list of Class II devices exempt from clinical trials
  • India’s CDSCO to pre-screen all applications for completeness
  • International Medical Device Regulators’ Forum
  • GHTF seeks comment on definition and classification of field corrective actions
  • Mercosur GMP Regulation for medical devices and IVDs
  • Malaysia seeks comments on IVD/product grouping guidances
  • Mexico publishes agreement on deregulation of medical devices
  • Saudi Arabia updates its medical device guidance documents
  • New framework for medical device clinical trials in Singapore
  • Singapore updates device guidance documents

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Environment Update

  • Proposed prohibition of mercury measuring devices in Europe

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Standards Update

  • Brazil creates two new committees to study technical standards
  • Health Canada consults on list of recognised device standards
  • Turkey becomes full member of CEN/CENELEC
  • Israel revises standard on menstrual tampons
  • Kenya publishes draft standard on orthopaedic devices
  • GMP standard for device manufacture in Mexico

More >>

Reference Section

  • Regulatory personnel on the move
  • Country overview: Egypt
  • Elemental essentials: European requirements for labels and instructions for use

More >>