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Journal of Medical Device Regulation Issue Headlines - August 2009

An Overview of the Medical Device Regulations in the Russian Federation

Russia is a potentially lucrative market for medical device companies; however, the registration of medical devices and medical equipment in the country is challenging. Although Russia has made efforts to improve the process in the last few years, there are still many areas of ambiguity. Perhaps most problematic for foreign manufacturers seeking device registration is that Russia still relies on a system of product testing as a tool for determining product safety and efficacy. As Russia has its own national standards, such testing is also required for products that are already cleared for marketing in Europe and the USA, for example. In this article, Elena Makarova explains the different stages in the registration process for medical devices in Russia, as well as providing guidance on the documentation requirements, timeframes and costs involved in the process. More >>

Regulation of IVDs in Australia

The Australian Therapeutic Goods Administration has proposed since early 2003 a new regulatory framework for in vitro diagnostics (IVDs). Originally proposed to be introduced in July 2005, the scheme has been incrementally delayed but always on the horizon. The regulatory changes are currently scheduled for implementation in mid to late 2009. However, as IVDs are regarded as a subset of medical devices, the proposed legislative changes will be achieved by additions and changes to various parts of the medical device regulations. This approach, as opposed to a separate chapter on IVDs, will make it difficult to appreciate the scope and complexity of the changes. In this article, Susan Alder reviews the information currently available on the proposed IVD regulatory framework and highlights the numerous deficiencies that still need to be addressed. More >>

The Void Between Fundamental Research and Clinical Investigation

For many medical devices, a void exists between fundamental research and clinical investigation for regulatory market clearance or approval. Although provision for performance evaluation prescribed by Directive 98/79/EC on in vitro diagnostics (extended by MEDDEV 2.14/2) offers certain possibilities for ‘research use only’ products, the other main Directives on medical devices do not. In this article, Haroon Atchia argues that introduction of similar provisions for medical devices and active implantable medical devices would help in overcoming various difficulties associated with their use for research, and regulate abuses. More >>

Patenting in the Medical Devices Sector

Patents, although intangible, can represent one of the most valuable assets for a company. The role of patents in protecting commercial products and ventures is vital in the healthcare sector in general, and the medical device sector is no exception. Accordingly, an understanding of the patent system and its operation is valuable for any company. This article by Noel J Akers discusses the general issues to be faced when contemplating patenting a new development relating to medical devices. The article considers why patents are of value and goes on to discuss what can and cannot be protected by way of a patent. The general procedures to be followed when filing a patent application and seeking patent protection internationally are discussed, together with the key issues to be addressed when deciding on when and where to file. The patent system demands timely action and decision-making can be difficult. This article will lead the reader through the key decision points and provide useful guidelines to assist in the decision-making process. More >>

European Update

  • Commission publishes guidance on Directive 2007/47/EC
  • Revision 3 of MEDDEV 2.1/3 on borderlines/classification
  • Manual on borderline and classification issues updated
  • First transition period for Directive 2005/50/EC nears end
  • CE certificates should not reference Directive 2007/47/EC
  • 24th meeting of the Competent Authorities
  • European pilot programme for electronic reporting of incidents
  • European agreement on sharps injuries
  • Finland to establish new Medicines Agency
  • Germany adopts revisions to Medical Devices Act
  • German DRG proposals for 2010 published
  • Responsibility for issuing Irish CFSs changes
  • IMB releases eight guidance documents
  • Updates on Italy’s Directory of Medical Devices
  • Portugal amends and consolidates medical devices laws
  • Sweden issues report on classification of IT systems
  • Notification of devices containing human tissue in Switzerland
  • Swiss guidance on requirements for self-service sales of devices
  • UK MHRA guidance on vigilance system for intraocular lenses
  • UK Medical Device Alerts

More >>

US Update

  • CDRH relocation
  • FDA’s FY 2010 budget invests in medical product safety
  • FDA creates transparency task force
  • Obama orders review of federal pre-emption
  • Draft guidance on presenting risk information in device promotion
  • Massachusetts issues guidance on device manufacturer conduct

More >>

International Update

  • Amendments to the Australian Therapeutic Goods Act 1989
  • Australian TGA fees and charges for 2009/10
  • Reducing level 2 application audit assessment fees in Australia
  • TGA’s OMQ creates technical working groups
  • Australia continues consultation on regulatory guidelines
  • Brazil to require GMP certificates for high-risk devices
  • Simplified registration of low-risk devices proposed in Brazil
  • Brazil publishes new medical equipment guide
  • Labelling changes for infrared thermometers in Canada
  • Health Canada drafts guidance on ‘significant change’
  • Draft Canadian guidance for implantable cardiac leads
  • Health Canada proposes revision of Class I device inspections
  • Findings of Canadian consultation on investigational testing
  • China publishes rules on medical device advertisements
  • SFDA issues six technical guidelines
  • QMS examinations for IVD reagents in China
  • Hong Kong now uses Asian nomenclature system
  • India develops new regulations for medical devices
  • Inclusion in clinical trial registry now mandatory in India
  • India proposes registration of Contract Research Organisations
  • NIPER offers assistance to Indian devices sector
  • GHTF documents
  • Timeline for development of ASEAN Medical Device Directive
  • Japan reinstates ‘me too’ application category
  • Korea plans to reduce requirements for foreign devices
  • Korea implements new classification system
  • Malaysian Medical Device Bureau relocates
  • Saudi Arabia issues interim medical device regulation
  • Taiwan plans to streamline Food and Drug Administration
  • Vietnam drafts regulation on electrical/electronic equipment safety

More >>

Environment Update

  • Industry challenges inclusion of DEHP in REACH Regulation
  • Proposed symbol for medical devices containing phthalates
  • Mercury sphygmomanometers in healthcare

More >>

Standards Update

  • Harmonised EU standards
  • ISO standard to tackle counterfeiting and fraud
  • ISO to develop standard on recall of unsafe products
  • CEN/CENELEC sign co-operation agreement with Korea
  • Japan proposes amendment to standard for biological ingredients
  • Korea proposes revision of standards for biological safety

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: Turkey
  • Elemental Essentials: ASEAN Common Submission Dossier Template (CSDT)
  • European medical device committees, working groups and task forces

More >>