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Browse English Issue Headlines - February 2007

Overview of the Regulatory Systems in China, Hong Kong, Japan and Taiwan

The regulatory systems in China, whose medical devices market is the 11th largest in the world, Hong Kong, Japan, which boasts approximately 23% of the world’s medical device market, and Taiwan have been summarised by Victoria Clark. Her report is based on presentations made at a conference organised by Management Forum in London, UK on 30 November and 1 December 2006 entitled ‘Medical Device Regulation in Japan, Greater China (PRC), Hong Kong and Taiwan’. The speakers at the conference were Qin Sun, Deputy Section Chief of the Department of Medical Devices Registration at the Shanghai Food and Drug Administration, John Worroll, Technology Manager at the British Standards Institute (BSI), and Bernard Sweeney, Head of Medical Devices at BSI Product Services.

21 CFR Part 11 and Risk Assessment

Title 21 of the US Code of Federal Regulations (21 CFR) Part 11 concerns electronic records and electronic signatures. In 2003, the Food and Drug Administration (FDA) issued the Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application for 21 CFR Part 11, partly due to concerns expressed by the industry that the breadth of applicability and the cost of Part 11 compliance were hindering the use of new technology. This guidance stated that records must still be maintained in compliance with the underlying predicate rules, but that the FDA will take a ‘risk-based’ approach to enforcing compliance to some of the technical controls for Part 11 such as validation, audit trails, record retention and record copying. It was the FDA’s intention to get back to its GxP (or predicate rule) fundamentals for the interpretation and enforcement of Part 11. These fundamentals involve systems for generating electronic records required in support of the Agency’s regulations for ‘best practices’ (together referred to as GxP) that encompass Good Clinical Practice, Good Laboratory Practice and current Good Manufacturing Practice. Victoria Lander’s article provides an overview of the basic risk assessment methodologies available to the medical device industry and explains how these can be adapted to meet the requirements of 21 CFR Part 11.

Best Practice Advice for Approaching Risk Analysis and Evaluation

The prominence of risk-based regulation of medical devices is now approaching its 17th year (since introduction of the Directive 93/42/EEC, as amended) and therefore we are provided with a great deal of experience of application as well as information on its effectiveness and problems associated with such controls. Since introduction of the approach by the European Union, recognition has extended to almost all continents, driven by the obvious benefits of uniform controls as part of the global harmonisation initiative. In this article, Haroon Atchia examines some practical concerns when assessing risk, comparing the expectations of the leading regulatory domains to medical devices. In addition, the use of prevailing standards for risk management is examined in relation to possible enhancement through investment in dependability characterisation and improvement. The discussion also touches on the use of safety and performance data in the post-production phase and considers common pitfalls inherent with risk management programmes.

Revision of EN ISO 10993-1: 2003, Evaluation and Testing

ISO DIS 10993-1: 2006, Evaluation and testing within a risk management system, which is under development, is a substantial update and revision of the 2003 publication and emphasises a new philosophy in the biological evaluation of medical devices. Under the risk management framework (ISO 14971) material characterisation is a crucial first step for hazard identification and risk analysis. A thorough evaluation of existing non-clinical and clinical data and experience relevant to the medical device is made by Expert assessors before any further in vivo testing is considered. The Experts will also determine and document: a) the rationale for selection and/or waiving of tests; b) the interpretation of existing data and results of testing; c) the need for any additional testing or data to complete the evaluation; and d) the overall biological safety conclusions for the medical device. There is an interaction of the risk management approach with chemical characterisation (ISO 10993-18), toxicological hazard identification and risk analysis, determination of allowable limits of leachables (ISO 10993-17) and the overall biological safety evaluation. This new, more rigorous scientific approach is considered to make best use of relevant existing data and helps to eliminate unnecessary animal testing without compromising on the biological safety of medical devices. In this article, John C T Lang explains why a new revision to the standard is required so soon, what the changes are likely to be, and what impact these will have on the medical device industry.

European Update

  • Belgium transposes Directive 2005/50/EC
  • New guidelines issued by the Czech Republic
  • Tooth whitening products in Denmark
  • EESC Opinion on advanced therapy regulation published
  • Final adoption of EU chemicals legislation (REACH)
  • Regulation on importation of Category 3 intermediate products
  • Draft MEDDEV on e-labelling of IVDs
  • Proposed changes to MEDDEV 2.12/1
  • Human tissues and cells
  • Regulation of clinical investigations in Europe
  • New Central European Free Trade Agreement signed
  • Changes to MRA between Switzerland and the EU
  • Harmonisation of frequencies for short range wireless devices
  • Bill to restructure BfArM approved by German cabinet
  • Draft Ordinance will update German device regulations
  • Reference prices for technical aids to be raised in Germany
  • New German ICD published
  • Increase in fees for medical device applications in Ireland
  • Irish guidance for manufacturers of systems and procedure packs
  • Reorganisation of the Portuguese Ministry of Health
  • INFARMED publishes strategic objectives for 2007
  • Reorganisation of the Swedish Medical Products Agency
  • Swissmedic issues information sheet concerning clinical trials
  • MHRA regulatory fees: proposals for 1 April 2007
  • Device Alert issued on use of incorrect lancing devices
  • Device Alert on reporting adverse incidents
  • UK guidance published on safe use of bed rails
  • UK guidance published on managing medical devices
  • Research finds public confidence in devices and medicines is high

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US Update

  • FDA strengthens postmarket programme for devices
  • Test procedures and acceptance criteria for medical gloves
  • Submission of validation data for reprocessed single-use devices
  • Immunology and microbiology devices: classification
  • Reclassification of the absorbable haemostatic device proposed
  • Comments sought on orthopaedic device reclassification
  • Cranial orthosis type devices: 510(k) exemption denied
  • Breast implants: final guidance updated
  • Decorative, non-corrective contact lenses: final guidance
  • Procedures for handling post-approval studies: final guidance
  • Medical device tracking: final guidance
  • Computed tomography: final guidance
  • Reporting and recordkeeping requirements: final guidance
  • Portable invasive BGMSs: draft guidance
  • Annual reports for approved PMAs: draft guidance
  • Radio frequency wireless technology in devices: draft guidance
  • ASRs: comment period extended on draft guidance
  • IVDMIAs: comment period extended on draft guidance
  • Disqualification of a clinical investigator: technical amendment

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  • Draft guidance on Asian Common Submission Dossier Template
  • MIAA issues Position Paper on formation of ANZTPA
  • Re-manufacture of single-use devices in Australia
  • MIAA asks government to subsidise wound care devices
  • Brazilian rules for the registration of IVDs are updated
  • Brazil revises legislation for intrauterine devices
  • Canada issues draft guidance on reusable medical devices
  • Chinese SFDA drafts Principles of Medical Device Nomenclature
  • Provisions for medical device recall drafted in China
  • Hong Kong proposes listing of local manufacturers
  • India proposes regulatory framework for medical devices
  • EU to negotiate Association Agreements with Central America and the Andean Community
  • 'Harmonisation by Doing' Program between USA and Japan
  • US and Colombia sign Trade Promotion Agreement
  • US and Lebanon sign Trade and Investment Framework Agreement
  • US and Panama complete FTA negotiations
  • Singapore and UAE sign Memorandum of Understanding
  • Australia New Zealand Therapeutic Products Authority
  • Global Harmonisation Task Force documents
  • Bulgaria and Armenia join CEN
  • IEC Affiliate Country Programme
  • New CENELEC members
  • Therapeutic Products and Medicines Bill tabled in New Zealand
  • Pakistan to establish a new Drug Regulatory Authority
  • Registration of medical devices in the Russian Federation
  • Registration of medical devices in South Africa
  • Taiwan to introduce new health insurance payment system

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Environment Update

  • NEMA calls for commitment to RoHS in electrical products
  • Finland fails to transpose WEEE and RoHS Directives in time
  • Marketing of certain mercury-containing measuring devices
  • Batteries and accumulators

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Standards Update

  • Harmonised EU standards
  • Modifications to the list of FDA recognised standards
  • Changes to sterilisation standards for medical devices
  • Revision of ISO 14971: 2000

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Reference Information

  • Regulatory personnel on the move
  • Country overview: Poland
  • Elemental Essentials: Own brand or private labelling
  • Device regulation in the EU: multi-lingual glossary (A-E)
  • International standards organisations (1)

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