Browse English Issue Headlines - February 2014

Biocompatibility requirements for medical devices – best practice, common pitfalls and how to avoid them

Henry Sibun’s article explains what is meant by ‘biocompatibility’ and why it is important for medical devices. It discusses the regulatory requirements pertaining to biocompatibility and how the ISO 10993 series of standards can be utilised to fulfil those requirements. The article highlights some common failings in biocompatibility submissions, and provides manufacturers with best practice recommendations for presenting data to regulators and on managing changes to medical devices. More >>

Combination products in the Asia Pacific region: points to consider when developing a marketing strategy

The emergence of the Asia Pacific region as a significant contributor to the global economy means many medical companies are continuing to concentrate their growth in that region. Introduction of new and more technologically-advanced products is a focus for industry as it seeks to deliver improvements in care and support further market growth. As has been seen in other markets, technologically-advanced products are increasingly involving the combination of medicinal products/biologics with medical devices (i.e. combination products). These products are challenging to regulators as they blur the traditional lines between medicinal products, biologics and devices and cannot easily be reviewed under the standard review pathways that exist for each of the separate entities in isolation. This article by Anthony Wilkinson focuses on the pathway to regulatory approval in the Asia Pacific region for combination products whose primary mode of action is considered to be predominately due to the device component. It discusses the general regulatory requirements for combination products in the region and then comments in more detail on specific requirements in Japan, Australia, China, South Korea, Taiwan, Hong Kong and Singapore. More >>

Legal recourse against delegated and implementing acts in the proposed European medical devices Regulation

Technical rules regarding competence and standing under European Union law are very important for medical device companies to consider. This area is likely to take on even more importance under the new proposed Regulations for medical devices and in vitro diagnostics because of the large number of delegated and implementing acts that the new Regulations make reference to. The purpose of this article by Erik Vollebregt is to provide an overview of the legislative and implementing acts in the European Commission’s medical devices Regulation proposal (without taking any proposed amendments into account) and to provide a prediction on the likely legal recourse for medical device companies. More >>

European News

  • Denmark issues fee schedule for 2014
  • Denmark publishes guide for doctors and dentists on use of new types of implants
  • Public consultation held on preliminary SCENIHR opinion on PIP breast implants
  • Device developers invited to participate in early dialogue pilot for HTAs
  • Member States discuss new device Regulation at EPSCO meeting
  • Delegated Directives adapt European RoHS Directive to technical progress
  • CENELEC publishes Amendment 1 to EN 60601-1:2006
  • Germany appoints new Healthcare Minister and agrees key future steps
  • Ireland updates guide for custom-made dental device manufacturers
  • Norway implements Commission Regulation (EU) No 722/2012 on medical devices containing non-viable animal tissue
  • New Norwegian Regulation on the handling of medical devices
  • Sweden clarifies dentists using CAD/CAM technology are manufacturers of custom-made devices
  • Major changes to regulatory procedures for medical device clinical trials in Switzerland
  • Turkey specifies requirements for issuing Certificates of Free Sale
  • Turkey to introduce new requirement for silver-coated devices in June 2014
  • Ukraine plans to harmonise device regulatory system with EU during 2014

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North American News

  • Health Canada removes fees from guidance documents to improve efficiency
  • Proposed Canadian Bill addresses key areas of concern regarding patient safety
  • Canada updates its list of recognised standards for medical devices
  • US FDA reorganises Office of Compliance
  • Jay Crowley, UDI team leader, leaves US FDA
  • US reclassification/PMA requirements for ECP cardiovascular devices
  • Intra-aortic balloons and control systems: reclassification/PMA requirements in the USA
  • Gastroenterology/urology and radiology devices: US reclassification/PMA requirements
  • Class II reclassification/renaming of temporary mandibular condyle prostheses
  • US reclassifies scleral plugs as Class II
  • Requirement for submission of information on paediatric uses of devices in the USA
  • Reclassification of cardiopulmonary bypass blood pumps proposed by US FDA
  • Pivotal clinical investigations: US guidance on design considerations
  • Guidance issued on correct labelling of IVDs for RUO or IUO
  • Guidance drafted on hearing aids and personal sound amplification products
  • Comments sought on draft US guidance on medical device development tools
  • FDA drafts two guidance documents on blood glucose monitoring test systems
  • Public consultation held on custom device exemption draft guidance
  • Reporting of computational modelling studies in US device submissions: guidance drafted
  • CDRH publishes proposed guidance development lists for 2014
  • Draft Technical Specifications published for GUDID HL7 SPL submission option
  • FDA/CMS pilot for parallel review of medical products extended by two years
  • Electronic submission of citizen petitions now accepted by US FDA
  • Priority recommendations for FDA following evaluation of MDUFA II/III
  • Modifications to the list of US FDA-recognised standards

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Central & South American News

  • New Technical Director requirements for certain medical devices in Argentina
  • Brazil proposes relaxation of some of its GMP requirements
  • Many previously-exempt device types will require market authorisation in Colombia
  • Ecuador revises standard on natural rubber latex condoms
  • Revisions to the regulation of medical devices in Peru

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Asia, Africa & Middle East News

  • AHWP issues a number of draft documents for public consultation
  • Australia and New Zealand commence further harmonisation programmes
  • Australian TGA publishes Key Performance Indicators
  • Technical reports to be accepted as interim evidence for joint reclassifications in Australia
  • Clarification on how European RoHS Directive may affect supplies to Australia
  • Simplified certification renewal process implemented in China
  • China drafts new Classification Rule
  • Comments sought on Chinese draft Rule on Good Supply Practices
  • China seeks comments on clinical trial approval provisions
  • China plans to issue 104 new medical device standards
  • Israel plans to update standards on medical electrical equipment
  • Japan to regulate medical devices separately under new Law
  • Malaysia publishes final versions of IVD guidance documents
  • Saudi Arabia requires Declaration of Conformity certification for imports
  • Timeframes to improve efficiency of marketing authorisation process announced by Saudi Arabia
  • New Chairman appointed to Board of Singapore’s HSA
  • South Korea exempts Class I devices from GMP requirements
  • South Korea proposes an Enforcement Rule for its Medical Devices Act
  • Vietnam requests feedback on Decree on Medical Devices

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Global Interest News

  • IMDRF Chairmanship moves to USA
  • Six regulatory documents finalised by the IMDRF
  • IMDRF opens consultation on IVD market authorisation Table of Contents
  • ISO publishes guidance on nanotechnology labelling

More >>

Reference Section

  • Country overview: Jordan
  • Elemental essentials: a practical guide to complying with EN ISO 14971:2012
  • Book review: Biomaterials in plastic surgery

More >>