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Browse English Issue Headlines - May 2007

Harmonisation of Medical Device Regulations in Asia

Asia is a rapidly growing region with about 75% of the global population. It has been estimated that Asia represents approximately 45% of the global healthcare market and this is anticipated to increase. Countries in the region are investing in healthcare infrastructure, which will see more hospitals and clinics been established, resulting in an increasing demand for medical devices. Many medical device industries from developed countries are also moving their manufacturing operations to the Asian region, so the movement of medical devices across the globe is seeing a changing pattern. The complexities and great diversity in the region are major factors that determine the free flow of medical devices in Asia. Dr Mukundan Sugunan Pillay, Chairman of the Asian Harmonisation Working Party (AHWP) discusses why it was felt that medical device regulations in Asia needed to be harmonised in line with the Global Harmonisation Task Force and to the subsequent formation of the AHWP.

Clinical Investigation of Medical Devices in Norway

Although Norway is not a member of the European Union (EU), it has the same rights and obligations for medical devices as other EU Member States because it is a signatory to the European Economic Area agreement. Norway implemented the provisions of the Active Implantable Medical Device Directive (90/385/EEC), the Medical Device Directive (93/42/EEC) and the In Vitro Diagnostic Directive (98/79/EC) through Act No 6 and Regulations No 25 relating to medical devices, which came into effect in Norway on 12 January 1995. This legislation established the systems under which manufacturers must submit information about clinical investigations performed in Norway to the Norwegian Competent Authority. In her article, Victoria Clark summarises the procedure for submitting clinical trial notifications in Norway and details what information these notifications should contain.

Packaging Waste Compliance in Europe

In the early 1990s, Europe realised it had a problem as landfill capacity was shrinking but the amount of packaging and other waste generated by industry and consumers was continuing to grow. Germany was the first country to take action by passing legislation to help curb the amount of packaging waste being generated. Other governments throughout Europe saw the wisdom of Germany’s efforts and, in late 1994, the European Union adopted the European Packaging Directive, modelled on Germany’s Packaging Ordinance, and now known as Directive 94/62/EEC on Packaging and Packaging Waste. In 2004, Directive 94/62/EEC was amended by Directive 2004/12/EC in an attempt to harmonise the national laws concerning the management of packaging waste and provide a high level of environmental protection. In this article, Ian Gordon examines the application of the current Packaging and Packaging Waste Directive to the medical device industry.

Successfully Interacting with the US FDA

Sponsors can do much to improve and optimise their interactions with the US Food and Drug Administration (FDA), says author of this article Elisa Harvey. Understanding the organisation and its underlying law and regulations, as well as being familiar with the relevant information available on the FDA’s website are important first steps. Utilising the FDA’s pre-IDE programme, whether you meet with the FDA or not, is a critical way to gain valuable feedback and establish a good working relationship with the FDA review team. Whether or not you intend to submit an IDE (Investigational Device Exemption) application, the pre-IDE process is the mechanism that the FDA has made available to sponsors to provide specific feedback on their preclinical and/or clinical test plans, and resolve questions of regulatory pathway. The single most important piece of the pre-IDE is the submission package. A clear, concise, comprehensive and well-organised package will make it easy for the FDA review team to understand a sponsor’s device and the issues and questions that need resolving. Knowing when in the device development process is the right time to request pre-IDE feedback is also essential, so that you use the process most effectively.

European Update

  • Fee increases in Denmark
  • Review of the Medical Devices Directives
  • Revision of ‘New Approach’ Directives
  • MEDDEV on IFU for IVDs
  • Guidance on Directive 2005/50/EC
  • IVD kit measuring parameters for evaluating risk of trisomy 21
  • Medical device vigilance guidance
  • Advanced therapies
  • Clinical Evaluation Task Force update
  • Dental amalgams: request for opinion from SCENIHR
  • Veterinary medical equipment
  • Parliamentary Question on plastics used in dentistry
  • Strategic objectives of Finland’s NAM
  • NAM annual report for 2006
  • German healthcare reforms
  • New guide on German DRG system
  • Ireland transposes Directive 2005/50/EC
  • MHRA regulatory fees
  • Reporting adverse incidents and disseminating Device Alerts
  • Adverse incident reports 2006
  • Medical Device Alerts
  • MHRA’s regulatory decision-making process
  • Intravascular and epidural devices

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US Update

  • FDA/VHA sign MoU on safe use of medical products
  • Recommendations to reauthorise MDUFMA
  • HSV Types 1/2 serological assays: reclassification
  • Cord blood processing system: classification
  • Anaesthesiology devices using oxygen: proposed reclassification
  • Statistical guidance on reporting diagnostic test results
  • HCT/Ps: final guidance
  • MQSA guidance document issued
  • Guidance on labelling for laser products
  • Membership of advisory committees
  • Modifications to devices subject to a PMA: draft guidance
  • Adverse event reporting: draft guidance
  • Technical amendments to certain regulations
  • Post-approval device study information
  • Global Medical Device Nomenclature
  • ITC review of Japan’s regulatory environment

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  • ANMAT issues three new Dispositions
  • 2007/8 annual charges from Australian TGA
  • Legislation to implement ANZTPA issued for consultation
  • Australian Therapeutic Advertising Code 2007
  • End of transition period for listing devices approaches
  • Guidance for IVDs
  • Reasons for rejection of device applications
  • TGA issues protocol for sending samples for testing
  • On-line payments now accepted for DEAL
  • New registration rules for IVDs postponed in Brazil
  • Brazil’s healthcare vigilance plan
  • Regulatory developments in China
  • Phase IV of Hong Kong’s MDACS launched
  • Hong Kong proposes listing of importers
  • India’s Central Drugs Authority approved
  • Australia/Japan FTA
  • USA/Korea FTA
  • Singapore signs MoUs with Cambodia/Brunei
  • GHTF documents
  • Japan proposes new consultation categories
  • New Zealand Therapeutic Products and Medicines Bill
  • Singapore drafts regulations on medical devices
  • Registration of medical devices in South Africa
  • New Thai import requirements
  • Contact lenses: Thai proposals for a Ministerial Announcement

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Environment Update

  • UK implements WEEE Directive

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Standards Update

  • CENELEC/ANEC sign co-operation agreement
  • ISO 14971: 2007
  • AAMI publishes standard for sterilisation containment devices
  • Laser classification and safety standard
  • Medical electrical equipment
  • IEC/ISO/ITU agree on common patent policy
  • Three new affiliates join IEC
  • Two new members of IECEE

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Reference Information

  • Regulatory personnel on the move
  • Legislative developments in Germany (in German)
  • Country overview: Kenya
  • Elemental essentials: STED
  • Obtaining product licences under Australia’s forthcoming IVD legislation
  • International standards organisations (Part 2)

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