Browse English Issue Headlines - May 2014

The borderline between medical devices and medicinal products: viewpoint of one European Competent Authority

There are a number of potential borderlines with medical devices (e.g. with cosmetics, personal protective equipment, biocides) but this article concentrates on the borderline area between medical devices and medicinal products – an increasingly complex and challenging area of classification. Since the introduction of the Medical Devices Directives in the 1990s, the gap between the regulatory oversight and controls applicable to the two regimes has widened, resulting in the classification as a medical device, in many cases, being more attractive to manufacturers. With current proposals for tightening of the regulatory system for medical devices and increasing focus on risk-based regulation of medicinal products, this gap should narrow again. The purpose of this article by Dr Janine Jamieson and Elizabeth Baker of the UK MHRA is to review the complex area of medical products that sit on the borderline between medical devices and medicinal products and discuss the current initiatives to help resolve some of the issues these products raise. More >>

Considerations for marketing combination products in the USA

John Barlow Weiner, Associate Director for Policy for the US Food and Drug Administration’s Office of Combination Products, offers some insights into the US approach to the regulation of combination products. His article also focuses on some implications of the regulatory approach in the USA for combination product development. More >>

Restrictions on hazardous substances: an overview of initiatives in the EU, China, India, South Korea and other markets

On 22 July 2014, the European Union (EU) will formally begin to enforce Directive 2011/65/EU on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment, commonly referred to as RoHS 2, with respect to medical devices. This article by Andrew Klobucar examines the scope and application of RoHS 2, as well as initiatives implemented by other countries to deal with hazardous materials. The article focuses on China, India and South Korea, but briefly covers the USA, Canada, Japan, Argentina and Australia/New Zealand. More >>

Latest developments in the creation of specific medical device regulations in India

At present, India regulates notified medical devices as drugs as defined in Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940. All other medical devices are unregulated. In vitro diagnostics (IVDs) are covered under Section 3(b)(i); however, some IVDs are also regulated as notified medical devices. On 17 March 1989, the first medical devices to be regulated as notified medical devices were disposable hypodermic syringes, needles and perfusion sets. This list has since grown to include 24 medical devices. For some time there has been a growing feeling in the Indian Government that medical devices cannot be regulated successfully as drugs. In 1994, the first action to separate medical devices from drugs was taken and subsequently, in 2008, a draft guideline for the manufacture of IVDs was proposed for inclusion as Schedule M IV. Several attempts have been made to introduce further changes, the latest being amendment legislation entitled the Drugs and Cosmetics (Amendment) Bill, 2013, which has been introduced into the Rajya Sabha (the Indian equivalent of the UK House of Lords or the US Senate). This article by Kanwal Jit Singh discusses the changes proposed in the draft Drugs and Cosmetics (Amendment) Bill, 2013. More >>

European News

  • Deadline for RoHS compliance of medical devices in Europe approaches
  • European Parliament finalises its reports on the proposed new medical device and IVD Regulations
  • Nine main areas of concern remain for industry in proposed EU IVD Regulation
  • Final opinion on environmental/health risks from mercury in dental amalgam published by EU’s SCHER
  • EU held public consultation on safety of BPA in medical devices
  • Public opinion sought by EU on safety of metal-on-metal joint replacements
  • Germany’s BfArM and Switzerland’s Swissmedic sign an agreement on closer collaboration
  • MEB in the Netherlands appoints new Director/Secretary
  • Chairman of the UK MHRA to step down later this year
  • UK publishes guidance on medical device standalone software, including apps

More >>

North American News

  • New Senate Bill would exempt low-risk software from US FDA regulation
  • CDRH unveils strategic priorities for 2014–2015
  • FDA to reorganise inspection and compliance activities
  • Report to Congress on policy for when to submit a 510(k) for modifications to a legally-marketed device
  • FDA proposes an update to the classification system for medical devices
  • From August 2015, medical device reports must be submitted electronically to the US FDA
  • Eyelid weights classified as Class II (special controls) in the USA
  • Stair-climbing wheelchairs re-classified into Class II (special controls)
  • US classifies John Cunningham Virus serological reagents
  • Class II classification for neuropsychiatric interpretive electroencephalograph assessment aids
  • Absorbable lung biopsy plug classified as Class II (special controls) in the USA
  • Proposed reclassification and renaming of shortwave diathermy devices
  • FDA provides advice on content of PMA annual reports
  • Guidance released on development of paediatric medical devices
  • Guidance on products subject to/released from medical device tracking requirements is updated
  • US guidance on requests for feedback on medical device submissions
  • Final US guidance published on communications during device submission review process
  • Administrative procedures for CLIA categorisation updated
  • Comments solicited on draft US guidance concerning 510(k)s for general surgery electrosurgical devices
  • US seeks feedback on draft guidance for bipolar electrosurgical vessel sealers for general surgery
  • Public consultation held on draft US guidance concerning medical devices containing animal-derived material
  • US revises guidance on recommended practices for distributing scientific and medical publications on unapproved new uses
  • US FDA drafts answers to commonly-asked questions on the Humanitarian Device Exemption process
  • New expedited access programme proposed for medical devices that address unmet medical needs
  • Advice drafted on balancing pre-market and post-market data collection for pre-market approval
  • Endotoxin testing recommendations for single-use IODs: draft guidance issued for comment
  • US guidance drafted on live case presentations during IDE clinical trials
  • Blood glucose test systems: extension of comment period on draft guidances
  • SOP published for Level 1, Immediately-in-Effect US guidance documents
  • SOP for resolving IDE application-specific issues
  • Health information technology: proposed strategy and recommendations for a risk-based framework
  • FDA no longer issues NHRIC and NDC labeller codes
  • New report outlines recommendations for improving transparency of compliance and enforcement data
  • Modifications to the list of US FDA-recognised standards

More >>

Central and South American News

  • New medical device traceability Resolution published in Argentina
  • Brazilian GMP no longer required for some low-risk medical devices and IVDs
  • Members of Brazilian medical technology associations to implement ethical business practices
  • Ecuador publishes draft Technical Regulation for external limb prostheses and external orthoses

More >>

Asia, Africa and Middle East News

  • AHWP drafts guidance for medical device distributors on QMSs
  • Recent changes to Australia’s Therapeutic Goods Act
  • Hip, knee and shoulder implant entries in Australian Prostheses List require updating
  • Important dates for annual charges and LVT exemptions in Australia
  • Consultation on Australia’s LVT exemption scheme review
  • China’s revised medical device regulations due to take effect on 1 June 2014
  • China introduces expedited review process for innovative medical devices
  • Modifications proposed to China’s product classification sub-catalogues of 6863/6864/6865 medical devices
  • Modifications proposed to China’s product catalogue for Class I medical devices
  • Catalogues of Class II/III medical devices exempt from clinical trials drafted in China
  • China launches special action programme to rectify problems within the device industry
  • India introduces a transition period for new labelling requirements
  • Israel revises mandatory standard SI 867 concerning clinical thermometers
  • Second amendment of mandatory standard SI 1268 on syringes and needles proposed by Israel
  • Japan’s revised Pharmaceutical Affairs Law to take effect in November 2014
  • New medical device guidance documents released in Malaysia
  • Philippines updates list of medical devices and IVDs requiring registration
  • Philippines adopts Code of Ethics for regulated medical device establishments
  • IEC 60601-2-54:2009 proposed for adoption in the Philippines
  • Saudi Arabia publishes enforcement dates for medical devices to have valid marketing authorisations
  • Saudi Arabia clarifies which commercial activities require an Authorised Representative licence
  • Fees for licensing importers and distributors of optical devices in Saudi Arabia
  • Singapore updates guidance on Change Notifications for registered devices
  • Creation of South African Health Products Regulatory Authority proposed
  • Appointment of a Quality Management Representative required in South Korea
  • South Korea proposes to exempt certain mobile medical devices from registration requirements
  • South Korea sets standards for electromedical safety
  • South Korea updates standards for biological evaluation of medical devices

More >>

Global Interest News

  • IMDRF consults on documents concerning MDSAP and software as a medical device

More >>

Reference Section

  • Overview of the medical device regulatory requirements in Lithuania
  • Elemental essentials: medical device-based registries
  • Meeting report: BioAfrica 2014 - growth strategies for medical devices

More >>