Journal of Medical Device Regulation Issue Headlines - August 2014

The changing environment for European Notified Bodies

Dr Gert Bos analyses some of the ongoing changes in expectations that influence the Notified Body environment in a post-Poly Implant Prothèse (PIP) scandal period. Most influential in this period is the Joint Action Plan initiated by the European Health and Consumer Policy Commissioner, John Dalli, in February 2012, which identified key areas requiring urgent improvement in the designation and supervision of Notified Bodies, as well as more strict interpretations of tasks to be performed by the Notified Bodies. Changes that may be implemented by the proposed new Regulation on medical devices are also discussed. More >>

China restructures its medical device regulatory system

China is currently engaging in a comprehensive effort to restructure its medical device regulatory system. Since its reorganisation in March 2013, the China Food and Drug Administration (CFDA) has issued numerous proposed rules and guidance documents related to, for example, device inspections, adverse event monitoring, gene sequencing reagents and instruments, and innovative devices. This effort has reached a new peak with the State Council’s adoption and promulgation of amendments that completely rewrite the core regulation governing devices, known as the Medical Device Supervision and Administration Regulation (MDR). The National People’s Congress has enacted no statutes governing medical devices; therefore, the MDR is currently the highest level of legislation in this area and sets out the framework for all aspects of medical device regulation in China, including research and development, approval and registration, registration amendment and renewal, manufacturing, importation, distribution, device use in medical institutions, advertising and promotion, post-market surveillance and penalties. The Revised MDR took effect on 1 June 2014. This article by Shaoyu Chen, Scott Cunningham, John Balzano and Nan Lou discusses some of the important changes in the Revised MDR and the basic features of some of the current implementation efforts. More >>

Medical device software – an overview of current and emerging regulations in the Asia Pacific region

Software exists in almost every active medical device no matter what its level of complexity. It can be implemented into a device as simple as a thermometer or as complicated as robotic surgical systems. Medical device software can generally be classified into one of two categories: embedded software and standalone software. Risk management and lifecycle management are two key factors for a manufacturer to consider when managing medical device software, and IEC 62304 provides a framework for manufacturers to follow. Tim Lin explains the benefits of utilising IEC 62304 when marketing medical device software before examining the specific requirements for software in China, South Korea, Taiwan, Japan, Australia and ASEAN. He then considers the trends for e-Health and m-Health, and the corresponding challenges these technologies bring to developers and regulators. More >>

How to build a successful regulatory affairs team to maintain a competitive advantage in the medical device industry

A significant part of a regulatory affairs manager’s role is to build the human resources and capabilities in the department to support the business growth strategy of the company. It is particularly important, therefore, to attract and retain the ‘right’ people with the ‘right’ knowledge, skills, behaviour, personality and attitude to obtain the necessary regulatory approvals, and to deal with the pressures of the business to market and sell products as quickly as possible. The objective of this article by Christopher Smejkal is to highlight some of the management theories and factors to consider when building and sustaining a successful regulatory affairs function, to help ensure retention of staff and to sustain an organisation’s competitive advantages in terms of the capabilities of a regulatory team in achieving regulatory approvals long into the future. More >>

European News

  • Czech Republic seeks input on proposed guidelines for requesting opinion on drug/device combinations
  • Denmark expands registration requirements for medical device manufacturers
  • Good progress made on Europe’s Joint Plan for immediate actions for medical devices
  • Amendment 1 to the third edition of EN 60601-1 now harmonised in Europe under the Medical Device Directive (MDD)
  • Giovanni La Via elected as new ENVI Committee Chair
  • NBRG releases draft consensus on interpretation and application of Z Annexes to EN ISO 14971: 2012
  • Manual on borderline and classification issues updated
  • Public consultation held on potential health effects of nanomaterials used in medical devices
  • Irish regulator becomes the Health Products Regulatory Authority
  • Entry of IVDs in Italy’s Register to follow same procedure as medical devices
  • Netherlands proposes ban on permanent wrinkle fillers for cosmetic purposes
  • Medical Products Agency in Sweden appoints new Director General
  • UK proposes revocation of 1993 regulation on clinical thermometers
  • New independent expert advisory group to replace UK’s Committee on the Safety of Devices
  • Ukraine postpones introduction of new conformity assessment system by one year

More >>

North American News

  • Canada proposes changes to its list of recognised standards for medical devices
  • US down-classifies certain nucleic acid-based in vitro diagnostic devices
  • Reclassification of blade-form endosseous dental implants from Class III to Class II confirmed
  • Two neurological devices intended to treat headaches classified into Class II
  • Class II classification assigned to powered surgical instruments intended to improve the appearance of cellulite
  • Non-absorbable expandable haemostatic sponges for temporary internal use are now Class II devices in the USA
  • US FDA classifies intravascular administration set, automated air removal system into Class II (special controls)
  • Colon capsule imaging system classified into Class II in the USA
  • Pancreatic drainage stents and delivery systems classified into Class II
  • US FDA classifies dengue virus serological reagents into Class II
  • UV lamps intended to tan the skin will be subject to pre-market notification from September 2014
  • Class I classification for non-powered lower extremity pressure wraps
  • US FDA proposes up-classification of surgical mesh and associated instrumentation
  • FDA proposes reclassification of antigen-based rapid influenza detection test (RIDT) systems
  • Proposals affecting cranial electrotherapy stimulator devices are withdrawn
  • Comment period extended on medical device classification procedures
  • Updates on US UDI requirements and the GUDID guidance for industry
  • Final guidance published by the FDA on providing information about paediatric uses of medical devices
  • Guidance issued to support responsible development of nanotechnology products
  • Guidance on assessing risks posed by magnetic resonance in diagnostic devices has been updated
  • Two draft guidance documents on Internet and social media platforms are issued for public comment in the USA
  • Enforcement discretion to be applied to compliance of Medical Device Data Systems under FDA proposal
  • Comments sought on acceptable use of voluntary consensus standards in US pre-market submissions
  • Substantial equivalence in 510(k)s: draft guidance on risk:benefit factors for different technological characteristics
  • Recommendations from independent assessment of US device submission review process
  • US FDA proposes strategic priorities for 2014-2018
  • FDA is accepting requests to participate in the CDRH 510(k) eSubmissions Pilot
  • Modifications to the list of US FDA-recognised standards

More >>

Central & South American News

  • Argentina issues specifications for fulfilling medical device traceability requirements
  • Simplified requirements for lower risk medical products proposed in Brazil
  • Brazil consults on packaging/labelling criteria for dental bleaching agents that are medical devices
  • Ecuador drafts Technical Regulations for dentistry products and electromedical equipment
  • Mexico clarifies its position on registration renewals

More >>

Asia, Africa & Middle East News

  • AHWP seeks feedback on software qualification and classification white paper
  • Establishment of joint Australia/New Zealand regulator may not go ahead
  • Australia extends timeframe for transitioning to the new IVD framework
  • Reclassification of hip, knee and shoulder joint replacements in Australia postponed until 30 June 2015
  • Australia lifts ban on manufacture and sale of self-test HIV kits
  • 2014 fees and charges released by Australia’s Therapeutic Goods Administration
  • Australia updates its list of Therapeutic Goods Orders and Information Specifications
  • Australian industry suggests improvements to regulatory system for medical devices
  • China consults on additional implementing measures
  • China issues 14 product registration guidelines and 120 industry standards for medical devices
  • Egypt to require ISO 13485 certification from October 2014
  • Hong Kong launches web-based classification programme for medical devices
  • Israel proposes to amend standards relating to medical gauze, gauze bandages and gauze pads
  • Malaysia amends its policies to aid in the implementation of the Medical Device Act 737
  • IVD product registration now incorporated into Malaysia’s MeDC@St on-line application system
  • Many products re-categorised as medical devices in New Zealand following implementation of updated definitions for medicines and medical devices
  • New Zealand updates user guide for WAND and clarifies notification requirements for IVDs containing material of animal origin
  • South Africa seeks feedback on draft regulations for medical devices and IVDs
  • South African court rules that combination devices are medical devices
  • South Korea proposes further amendments to medical device regulations

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Global Interest News

  • An update on the revision of ISO 13485

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Reference Information

  • Overview of the medical device regulatory requirements in the Kingdom of Saudi Arabia

More >>