Browse English Issue Headlines - February 2018

Guest Editorial: The Medical Device Coordination Group (MDCG) – A successor to the MDEG or a new CHMP in the making?

The Medical Device Coordination Group (MDCG) was a key point of discussion and negotiation during the extended deliberations over the adoption of the new Medical Devices Regulation and In Vitro Diagnostics Regulation. The Group became a focus for those who wanted a more pharmaceutical/centralised approach, including some who wanted a role for the European Medicines Agency in the control of devices. This article explores whether the MDCG is simply a continuation of the Medical Devices Experts Group (MDEG), which was established under Directive 93/42/EEC, or whether it could perhaps be the forerunner of a European medical devices agency. More >>

Focus: What changes are expected in 2018 for Brazil’s medical device regulations?

This article explores the changes that are likely to have the greatest impact on companies’ regulatory strategies during 2018. Firstly, it sets out the official regulatory agenda from Brazil’s National Health Surveillance Agency (ANVISA) for the next four years. Secondly, it reminds readers about deadlines that are coming into force in the near future. Last but by no means least, it summarises the most significant medical device regulation published recently in Brazil: Resolution RDC No 183 of 17 October 2017, which concerns the inspection programmes and administrative procedures for the granting of Good Manufacturing Practice certificates to manufacturers of medical devices located outside the Brazilian territory and Mercosur. This new Resolution makes it clear that ANVISA intends to reduce the international inspection waiting times; however the regulatory text is not consolidated, is often confusing and is sometimes misleading, even for native Portuguese speakers and regulatory experts. More >>

Focus: A review of ISO/TR 24971:2013 concerning the application of ISO 14971 for the risk management of medical devices

New editions of ISO 14971, Medical devices – Application of risk management to medical devices and its companion document ISO/TR 24971, Medical devices – Guidance on the application of ISO 14971 are being prepared by a Joint Working Group from ISO/TC 210 and IEC/SC 62A. Work started in April 2017 and the documents are expected to be published in 2019. According to numerous observers, including the International Organization for Standardization (ISO), a systematic review of the current version of ISO 14971 has revealed numerous instances of incoherent and asymmetric information, particularly by comparison with the medical devices legislation in the European Union. Therefore, the Joint Working Group has been tasked to improve the explanation of the requirements and provide more guidance on how to perform risk management. This article examines critically the current edition of ISO/TR 24971 and identifies areas where this author believes improvements should be considered. More >>

Country Overview: The medical device regulations in Singapore

The Health Products Regulation Group under the Health Sciences Authority regulates medical devices in Singapore to ensure they meet the appropriate quality, safety and efficacy standards. Singapore’s regulatory framework controls the following areas in the medical device lifecycle: pre-market, on-market and post-market through product registration; dealer licensing; and reporting of adverse events. All of these topics, including the associated fees and timeframes, are addressed in this summary document. More >>

Country Overview: Lithuania’s regulatory requirements that apply to medical devices and in vitro diagnostic medical devices, written by the CA

The Medical Devices Market Surveillance Division of the Lithuanian State Health Care Accreditation Agency has summarised the regulatory requirements that apply to medical devices and in vitro diagnostic medical devices in Lithuania. The report outlines the relevant national legislation, the applicable regulatory controls, details of the application forms, as well as national language requirements. Information on clinical investigations, and vigilance and post-market surveillance activities is also provided. More >>

European News

  • EU: Codes and corresponding device types, application forms, and application documentation for Notified Body designation
  • EU: Conditions for the exemption of reused spare parts recovered from EEE
  • EU: Publication of new list of harmonised European standards, including EN ISO 13485:2016, EN ISO 15223-1:2016 and EN ISO 14155:2011/AC:2011
  • EU: Manual on borderline and classification issues updated
  • EU: FAQ documents address transitional provisions of the MDR and IVDR
  • EU: IMDRF adverse event reporting terminology to be utilised in Europe
  • Finland: First phase of legislative changes to implement new European Regulations on medical devices and IVDs
  • Switzerland: Process of aligning Swiss medical device legislation with the new European Regulations begins

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North American News

  • Canada: Introduction of reduced MDSAP audit times
  • Canada: Regulations affecting dental x-ray equipment have been amended
  • Canada: Proposed amendment of rules concerning disclosure of information from clinical studies or investigational testing
  • Canada: Guidance issued for manufacturers of HIV RDTs for use at the point of care or for self-testing
  • Canada: Guidance drafted on applications for medical device Investigational Testing Authorisations (ITAs)
  • Canada: Scope of the Regulatory Enrolment Process using the Common Electronic Submission Gateway may be expanded to include medical devices
  • USA: Controversial medical device excise tax suspended for another two years
  • USA: Classification of the external negative pressure airway aid into Class II
  • USA: Class II classification for the image processing device for estimation of external blood loss
  • USA: Pressure wedge for the reduction of caesarean delivery classified into Class II
  • USA: Class II classification for the external vagal nerve stimulator for headache
  • USA: Special controls established for rectal balloon for prostate immobilisation as part of Class II classification
  • USA: FDA classifies flow cytometric test system for haematopoietic neoplasms into Class II
  • USA: Computerised behavioural therapy device for psychiatric disorders has been classified into Class II (special controls)
  • USA: Irrigating wound retractor device classified into Class II
  • USA: Class II classification and special controls for the whole slide imaging system
  • USA: Class II classification is deemed appropriate for the foetal head elevator
  • USA: Tear electrostimulation devices are classified into Class II
  • USA: Class II special controls established for the genetic health risk assessment system
  • USA: Class II classification for the non-EEG physiological signal based seizure monitoring system
  • USA: Automated indirect immunofluorescence microscope and software-assisted system receives Class II designation
  • USA: Total 25-hydroxyvitamin D mass spectrometry test system has been classified into Class II (special controls)
  • USA: Newborn screening test for SCID becomes Class II following a de novo request
  • USA: Classification of the Aquaporin-4 autoantibody immunological test system into Class II
  • USA: Class II classification for the acute kidney injury test system
  • USA: Class II classification deemed appropriate for the Streptococcus spp nucleic acid-based assay
  • USA: BCR-ABL quantitation test classified into Class II
  • USA: Class II classification for the prostatic artery embolisation device
  • USA: Absorbable perirectal spacer receives Class II assignment
  • USA: Class II classification for the cervical intraepithelial neoplasia (CIN) test system
  • USA: Class I classification deemed appropriate for reagents for molecular diagnostic instrument test systems
  • USA: 510(k) exemption, subject to limitations, for autosomal recessive carrier screening gene mutation detection system devices
  • USA: Correction to the classification of the oral removable palatal space occupying device for weight management and/or weight loss
  • USA: Reclassification and renaming of single-use female condoms proposed
  • USA: Needle destruction devices to be renamed and reclassified under proposed order
  • USA: Proposed delay of effective date: when products made/derived from tobacco are regulated as drugs, devices or combination products; amendments to regulations regarding intended uses
  • USA: Certain Class II surgical apparel proposed for 510(k) exemption
  • USA: Proposed rule on the procedures for internal agency supervisory review of certain decisions made by the CDRH
  • USA: Guidance on when to submit a 510(k) for a change to an existing device
  • USA: Deciding when to submit a 510(k) for a software change to an existing device
  • USA: Final guidance released on the de novo classification process (evaluation of an automatic Class III designation)
  • USA: New guidance details UDI compliance policy for Class I and unclassified medical devices
  • USA: Guidance published on direct UDI marking of medical devices
  • USA: Updated guidance issued on medical device accessories and their classification
  • USA: Guidance on sharing patient-specific information from a medical device
  • USA: Technical considerations specific to devices using additive manufacturing (3D printing) are subject of new guidance
  • USA: FDA categorisation of IDE devices to assist the CMS with coverage decisions is the subject of new guidance
  • USA: Guidance issued on inclusion of paediatric information/labelling for X-ray imaging devices in pre-market notifications
  • USA: Labelling of certain ultrasonic surgical aspirator devices should include a specific safety statement
  • USA: Three new digital health policy documents unveiled
  • USA: Proposed expansion of the least burdensome provisions set out in new guidance
  • USA: Acceptance review policies for de novo classification requests drafted in the form of guidance
  • USA: Updates proposed to guidance on replacement reagent and instrument family policy for in vitro diagnostic devices
  • USA: Draft guidance on IVDs used in clinical investigations of therapeutic products circulated for public comment
  • USA: Consultation has been held on draft guidance concerning implementation of the Breakthrough Devices Program
  • USA: Guidance drafted on the evaluation of devices used with Regenerative Medicine Advanced Therapies
  • USA: Public warning and notification of recalls discussed in new draft guidance
  • USA: Comments sought on draft guidance documents concerning CLIA waiver applications
  • USA: CDRH publishes proposed guidance development lists for fiscal year 2018
  • USA: eMDR adverse event codes to change in April 2018
  • USA: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program
  • USA: Voluntary Malfunction Summary Reporting Program proposed
  • USA: Modifications to the list of US FDA-recognised standards

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Central & South American News

  • Brazil: Medical device registrations valid for 10 years instead of five years
  • Brazil: Good Manufacturing Practice certification of foreign medical device manufacturers
  • Brazil: Importation process for medical devices has been simplified
  • Brazil: Criteria and processes for importing unregistered medical devices
  • Brazil: Mandatory inclusion of standard barcodes on traceability tags for cardiac stents, and hip and knee implants proposed
  • Brazil: Updated list of technical standards to be adopted in the certification of conformity

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Asia, Africa & Middle East News

  • Australia: ‘Therapeutic Goods (Manufacturing Principles) Determination 2018’
  • Australia: Implementation of new Uniform Recall Procedure for Therapeutic Goods
  • Australia: Guidance on priority review designations for medical devices, including IVDs
  • Australia: Regulatory changes proposed for personalised and 3D printed medical devices
  • China: New rules on the supervision and management of online medical device sales
  • China: Plans to abolish mandatory in-China type testing, accept international clinical trial data, and conduct more overseas inspections
  • China: Consultation held on proposed amendments to the ‘Regulations on the Supervision and Administration of Medical Devices’
  • China: ‘Guiding Principles on the Registration of Mobile Medical Devices’ published
  • China: Numerous technical guidelines have been published by the CFDA
  • China: Six new industry standards published; two repealed
  • EAEU: Proposed modifications to the requirements for products subject to sanitary and epidemiological control
  • India: Classification of medical devices and IVDs under the ‘Medical Devices Rules, 2017’
  • India: Import process clarifications for medical devices and IVDs should ease delays
  • Israel: Standard for colour coded identification of single-use hypodermic needles updated
  • Japan: Partial amendment proposed for Standard for Ruminant-Derived Ingredients
  • Kenya: Parts 1 and 2 of Kenya Standard DKS 2612 on prostheses proposed for adoption
  • Kenya: New standard developed to set quality specifications for neck and spinal orthoses
  • Korea: Several regulatory amendments affecting medical devices were published in late 2017
  • Korea: Agreement to support the marketing of advanced and innovative medical devices
  • Korea: Ministry of Food and Drug Safety joins International Medical Device Regulators Forum (IMDRF)
  • Malaysia: Extension of the moratorium on the registration of medical devices
  • Pakistan: ‘Medical Devices Rules, 2017’ published
  • Philippines: New procedure for applications to amend existing Certificates of Product Registration
  • Philippines: New rules for obtaining customs clearance of radiation devices
  • Saudi Arabia: Draft guidance on requirements for following up and closing medical device Field Safety Notices (FSNs)
  • Vietnam: New guidance released on Class B, C and D medical devices

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Global Interest News

  • IMDRF: Essential Principles of safety and performance of medical devices and IVDs

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Reference Section

  • Roadmap for implementation of the European Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR)

More >>