Browse English Issue Headlines - February 2019

Reforming Australia’s regulations – doing more with less Down Under

The 2015 Sansom review of Australia’s medical device legislation was accepted in full by the Australian Government and has shaped the path of subsequent regulatory reform. The review did not call for any changes to the fundamental core of the regulations: risk-based classification, use of consensus technical standards to demonstrate compliance with Essential Principles, and regulatory intervention based on risk class were all recognised as best practice approaches. Therefore, regulatory reforms have not required major changes to the law but instead have focussed on more subtle regulatory adjustments and development of new or strengthened processes. This continued through 2018, with several significant developments in both pre- and post-market regulations of medical devices. This article summarises the major changes that took place in 2018 and looks forward at what is anticipated during 2019. More >>

Adopting a strategy to identify products with the highest commercial value for certification under the new EU Regulations

Although it is almost two years since the European Union (EU) approved the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), many organisations are still preparing for the transition. The regulatory authorities are hoping that the new Regulations will provide a more transparent and uniform process for certifying new medical devices and in vitro diagnostics (IVDs), as well as re-certifying existing ones. Yet, with limited time remaining (only two years left to comply with the MDR, and four years for the IVDR), the clock is ticking for manufacturers who may still be questioning the cost-effectiveness of re-certifying product portfolios, and how to expand data collection resources and post-market surveillance to meet the new requirements. This article outlines a three-step approach to identifying products with the highest commercial value, which in turn can help manufacturers prioritise their medical devices and IVDs for compliance with the new EU Regulations. More >>

Digital health – an opportunity or a challenge?

The exponential growth of digital products used in healthcare presents a 21st century challenge for legal regulation. The aim of enabling safe products to come to market quickly requires that innovation is not stifled but that patients are not subjected to unnecessary risks or harm. The trends in digital products, that are as relevant to health as other industries, arguably more relevant than other industries, will require those who are experts in technology to be able to communicate appropriately to those in healthcare and with lawyers involved in regulation, to produce a system that works comprehensively and makes the best use of collective knowledge. This article will consider digital health and the changes to device legislation which impact it. More >>

An overview of the medical device regulations in Chile

The level of medical device regulation is not high in Chile as only five types of medical devices are, in practice, subject to mandatory control. Medical devices are governed by Supreme Decree No 825/98 (Regulations with Control of Medical Use Products and Elements) and Decree No 725 (the Sanitary Code). The Supreme Decree establishes that further supreme decrees should be issued by the Ministry of Health, and the application of the Decree will become progressively applicable to other devices and medical elements. This article summarises the risk classification of medical devices in Chile, the registration procedures that exist, the procedures that apply to products that do not require sanitary registration, vigilance activities, and future plans for the expansion of medical device regulatory control. More >>

European News Updates

  • EU: More advisory documents issued to support implementation of MDR and IVDR
  • EU: Manual on borderline and classification issues updated
  • EU: New form for medical device incident reporting by manufacturers
  • Serbia: Registration requirements, wholesale dealing and manufacturer obligations covered by new legislation
  • Serbia: New ‘Law on Medical Devices’ fully implemented; electronic submissions now accepted
  • Spain: Clinical investigations involving CE marked devices may now be notified to AEMPS electronically
  • Spain: Launch of national registry of pacemakers and ICDs
  • UK: MHRA issues guidance and drafts contingency legislation for a no deal scenario
  • UK: Guidance updated on leadless cardiac pacemaker therapy

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North American News Updates

  • Canada: Non-compliant device labels may now be relabelled/corrected after importation
  • Canada: Priority review process for device applications to be streamlined and expanded
  • Canada: Guidance on the requirements for recognising an MDSAP Auditing Organization
  • Canada: Consultation on pre-market requirements for medical device cybersecurity
  • Canada: Draft guidance on licensing requirements for 3D printed medical devices
  • Canada: ‘Action Plan on Medical Devices’ is released
  • USA: Incorporating FDASIA modifications to the medical device classification procedures
  • USA: Reclassification of ECT devices; effective date of requirement for a PMA for ECT devices for certain specified intended uses
  • USA: Insulin therapy adjustment devices placed into Class II
  • USA: Class II classification for the active implantable bone conduction hearing system
  • USA: Class II classification deemed appropriate for the high flow humidified oxygen delivery device
  • USA: Meprobamate test system classified into Class II
  • USA: Withdrawal of proposed rules on laser products’ performance standard and electronic labelling submission for certain home-use devices
  • USA: Proposed regulation of medical device de novo classification process
  • USA: Proposal to end temporary extension of GUDID’s grace period
  • USA: Revised policy on UDI direct marking compliance dates
  • USA: Policies for implementing Breakthrough Devices Program set out in new guidance
  • USA: Guidance released on manufacturing site change supplements
  • USA: Comments sought on draft guidance concerning blood glucose monitoring test systems for prescription point-of-care use
  • USA: Draft guidance issued on self-monitoring blood glucose test systems for over-the-counter use
  • USA: Guidance drafted on developing and labelling in vitro companion diagnostics for a specific group or class of oncology therapeutic products
  • USA: Draft guidance documents concerning CLIA waiver applications revised and re-issued
  • USA: Further plans to modernise the pre-market notification (510(k)) programme
  • USA: ‘Medical Device Enforcement and Quality Report’ shows improved compliance rates

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Central & South American News Updates

  • Brazil: Electronic submission of application documentation to replace paper copies
  • Brazil: Proposal for ‘classifying’ medical devices as single use or reusable
  • Brazil: ABNT NBR IEC 60601-1-2:2010 is replaced by 2017 version
  • Peru: Addition of Hungary as a country of high sanitary surveillance

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Asia, Africa & Middle East News Updates

  • Australia: Reclassification of surgical mesh devices and publication of associated guidance
  • Australia: Proposed fees and charges for 2019–2020
  • Australia: Consultation held on changes to definitions and scope of device regulations
  • Australia: Potential reclassification of active medical devices for diagnosis and patient therapy
  • Australia: Proposed introduction of a Unique Device Identification (UDI) system
  • Australia: New guidance on menstrual cups is released
  • Australia: Guidance drafted on medical device cybersecurity
  • Australia: ‘Therapeutic Goods Advertising Code (No 2) 2018’ now in effect
  • China: Special review procedure for innovative medical devices
  • China: New checklist designed to improve clinical trial data and guide inspections
  • China: Creation of a voluntary record filing system for Device Master Files proposed
  • Hong Kong: Listing of Class B and Class C IVDs starts in February 2019
  • India: Four new medical devices to be included in definition of drugs
  • India: Surgical gowns and drapes could become notified medical devices
  • India: Electronic instructions for use now accepted
  • India: Guidance on Certificates of Free Sale for notified medical devices
  • Israel: SI 798 Part 1, dealing with spectacle lenses for ophthalmic optics, is to be replaced
  • Malaysia: Updated guidance on medical device labelling has been published
  • Malaysia: Guidance explains requirements for a CFS application for an export only device
  • Malaysia: Change notification guidance is updated for a third time
  • New Zealand: Proposal for increased medical device regulatory controls
  • Saudi Arabia: Updated timeframes/criteria for deleting MDMA applications
  • Saudi Arabia: New final and draft guidance documents released
  • Singapore: Updated guidance drafted on preparation of a product registration submission

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Global Interest News Updates

  • IMDRF: Optimising standards; Essential Principles; personalised medical devices
  • ISO: Third edition of ISO 14155 on clinical investigations reaches DIS stage

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