Journal of Medical Device Regulation Issue Headlines - November 2016

Guest Editorial: Australian medicines and medical devices regulation review – the Government’s response and industry’s reaction

Last year, an independent panel led by Professor Lloyd Sansom AO published its findings following a review of the Australian regulatory framework for therapeutic goods. The Commonwealth Government’s long anticipated response to the Review was finally released on 15 September 2016. According to the Government’s response, ‘implementing multiple pathways to marketing authorisation will streamline access to medical devices for consumers, provide additional flexibility for sponsors, and is consistent with the Government’s regulatory reform’. The Medical Technology Association of Australia, the primary body representing the medical device industry in Australia, has welcomed the Government’s response and in particular the decision to accept the recommendations for greater use of overseas assessment reports and for expedited access to innovative and life-saving products. This article summarises the main recommendations of the Review affecting medical devices and looks at the Government’s response. More >>

Additive manufacturing and 3D printing: US FDA’s proposed draft guidance and industry perspectives

Rapid advancements in printing technology have increased the use of additive techniques in medical device manufacturing, commonly referred to as additive manufacturing (AM), a category that includes three-dimensional (3D) printing. Manufacturers are now able to produce patient-matched devices using medical imaging data to manufacture products to fit that patient’s anatomy. AM also enables locally-based production, often referred to as ‘point-of-care manufacturing’. In response to this emerging technology, the US Food and Drug Administration (FDA) has issued draft guidance providing technical considerations for the design, manufacture and testing of medical devices that include at least one AM step. Industry comments on the draft guidance ask for more specifics, as well as clarification that certain recommendations apply only to particular technologies. Some commenters challenge the FDA’s recommendations, claiming that they go beyond what is required under current law or are not technologically feasible. Even with the open questions in the draft guidance, manufacturers can use the concepts outlined in the guidance, and summarised in this article, to guide their thinking on the potential risks introduced by AM, and the appropriate ways to manage those risks during production. More >>

UDI compliance and the important lessons for Europe

Unique Device Identification (UDI) is a system which is used to identify medical devices through their distribution and use. The system is expected to improve patient safety and healthcare business processes, and the US Food and Drug Administration, for example, has made patient safety a strategic priority by developing specific legislation for UDI. However, with the imminent publication of the Medical Device Regulations in Europe, UDI is expected to become a prerequisite for all medical device manufacturers. There is a lot of effort required to implement UDI; however, manufacturers stand to gain significant long-term benefits (including influencing their bottom line) if they ensure they are meeting compliance standards early on in the implementation process. This article explains why it is important for European manufacturers to meet UDI compliance standards as soon as possible, by highlighting the main lessons learned from UDI adoption in the USA. More >>

China RoHS 2.0 is here

China has implemented the first revision to its Restriction of Hazardous Substances (RoHS) for Electrical and Electronic Products Regulation since 2006. The purpose of updating this Regulation is threefold: to control and reduce the environmental pollution caused by wasted electrical and electronic products; to promote ‘green’ production and recycling of resources in the electrical and electronic industry; and to encourage ‘green’ consumption to protect both environmental and human health. From a practical perspective, the key updates to RoHS 1.0 include an expansion of the scope of applicable products from ‘electronic information products’ to ‘electrical and electronic products’, as well as the forthcoming government-issued Mandatory Product Compliance List for certain products whose hazardous substance content must be reduced below a certain limit. The transition to the updated Regulation for those suppliers who had previously been compliant with the first edition of RoHS should not be too onerous as the underlying requirements of both hazardous substance content limits and product labelling remain largely similar. However, care must be taken to monitor the progress and issue of the forthcoming Mandatory Product Compliance List. For those manufacturers and suppliers of products who have not previously needed to meet the requirements of RoHS, testing according to national standards must be undertaken to determine the content of hazardous substances in their products and the product labelling must be updated accordingly. This article explains the new requirements and describes the practical implications for suppliers that arise from the updated Regulation. More >>

European News

  • Proposed Regulations for medical devices and IVDs translated into all EU languages
  • German Federal Ministry finally approves benefit assessment procedural rules

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North American News

  • Disinfectants and sterilants for use on medical devices to be reclassified as medical devices in Canada
  • Health Canada announces deadline for transitioning to ISO 13485:2016
  • Health Canada publishes updated guidance on classification of IVDDs
  • US guidance materials may be used to support Canadian medical device licence applications
  • FDA medical device user fees decrease by over 10% for Fiscal Year 2017
  • Upper extremity prostheses receive Class II classification
  • Class II classification for the magnetic surgical instrument system
  • Iontophoresis devices for ‘any other purposes’ are now Class II prescription devices with special controls
  • Ophthalmic devices: Class II classification and special controls for strabismus detection devices
  • Apical closure device has been classified into Class II (special controls)
  • Evoked photo image capture devices are classified as Class I and exempt from pre-market notification
  • Electronic submission of labelling for certain home-use medical devices proposed
  • Extensions announced for certain UDI and GUDID compliance dates
  • Guidance provides clarification on CDRH’s compliance policy for general wellness products
  • Use of adaptive designs for medical device clinical studies described in new final guidance
  • Guidance provided on preparing a 510(k) for an electrosurgical device used in general surgery
  • Guidance provided on preparing a 510(k) for a bipolar electrosurgical vessel sealer used in general surgery
  • FDA advises on collection, submission and use of patient preference information
  • Recommendations provided on the reporting of computational modelling studies in medical device submissions
  • FDA clarifies its enforcement policy on NHRIC and NDC numbers assigned to medical devices
  • FDA issues recommendations on 510(k)s for blood glucose test systems to differentiate self-test and prescription uses
  • Guidance on the submission of a 510(k) for a solid state x-ray imaging device
  • Updated recommendations on submitting a new 510(k) for device modifications have been drafted
  • Form and content of Unique Device Identifier (UDI) is subject of draft FDA guidance
  • Draft guidance issued on the 510(k) Third Party Review Program
  • Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: draft guidance released
  • Consultation held on use of real-world evidence to support regulatory decision-making for medical devices
  • Guidance drafted on regulatory policy for medical x-ray imaging equipment
  • CDRH outlines regulatory science priorities for 2017
  • Modifications to the list of US FDA-recognised standards
  • AAMI appoints new President and CEO

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Central & South American News

  • Brazil extends deadlines for meeting new technical dossier requirements
  • Consultation on reuse of medical devices takes place in Brazil
  • Colombia streamlines renewal process for low-risk medical devices

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Asia, Africa & Middle East News

  • Australia sets transition deadline for ISO 13485:2016
  • MTAA Chief Executive resigns for health reasons
  • Additional Chinese documentation requirement applies for certain medical device and IVD registration applications from November 2016
  • CFDA exempts more medical devices from local clinical trial requirements
  • Revised version of medical device classification catalogue published for comment in China
  • China to implement 14 mandatory medical device standards from 1 January 2017
  • Egypt publishes mandatory standard for surgical drapes, gowns and clean air suites
  • India proposes fee structure under Medical Device Rules, 2016
  • India controversially includes coronary stents on NLEM, bringing them under pricing control
  • Malaysia to introduce fees for issuing product classification determinations
  • Malaysia grants two-year transition period for implementing new labelling requirements
  • Guidance drafted in Malaysia on notification of registration-exempt devices for clinical research
  • Philippines introduces new application filing procedures
  • Saudi Arabia formally reclassifies certain borderline products as drugs instead of medical devices
  • Singapore solicits comments on proposed regulatory guidelines for telehealth devices
  • South Africa issues Guideline concerning implementation of medical device and IVD regulations

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Global Interest News

  • IMDRF consults on new draft guidance documents
  • Additive manufacturing standards development structure created

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Reference Information

  • Overview of the medical device regulatory requirements in Kenya
  • Book review: Handbook of Cardiac Anatomy, Physiology and Devices, Third Edition

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