Browse English Issue Headlines - February 2017

Impact of recent changes to Japan’s medical device regulations: a Competent Authority perspective

Medical devices distributed in Japan are subject to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics, which has been enforced since November 2014 and made major revisions to the Pharmaceutical Affairs Law. This article reflects on the two years that have passed since implementation of the Act, and the progress that has been made as a result of the changes. The article also looks at the recent introduction of other key regulatory activities in the medical device field by the Japanese regulatory authorities: the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency. More >>

US FDA guidance on the use of ISO 10993-1 for the biological evaluation of medical devices: the top 10 changes affecting medical device manufacturers

The original guidance from the US Food and Drug Administration (FDA) on the biological evaluation of medical devices was The Blue Book Memorandum #G95-1, Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing’, dated 1 May 1995. This document persisted unchanged for nearly two decades, even though practices and opinions within the FDA slowly changed. In June 2016, the FDA published the final version of a new guidance document entitled, Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’. The new guidance focuses on the possible biological and toxicological risks presented by medical devices, and outlines testing approaches to address these risks when bringing a medical device to market. This article identifies the top 10 changes to biocompatibility evaluation introduced by the new guidance document and looks at their impact on medical device manufacturers. More >>

Addressing the challenges of medical device registration in the Dominican Republic – requirements, trademarks, samples and timeframes: a Competent Authority perspective

Knowledge of response times, requirements that must be met, trademarks and samples is crucial for obtaining sanitary registration of medical devices in the Dominican Republic, so it is important to understand the regulatory framework that underpins the registration of these products in the country. The regulations for medical devices in the Dominican Republic are established in the General Health Law 42-01 and Decree 246-06 (Regulation on Medicines); according to this legislation, medical devices are known as sanitary products. This article summarises the minimum requirements for registration, the rules for trademarks and sample submission, the approval timeframes, and the simplified procedure for sanitary registration. More >>

The need for increased US FDA oversight of laboratory-developed and other laboratory tests

The US Food and Drug Administration (FDA) still plans to increase oversight of laboratory-developed tests (LDTs), despite an announcement in November 2016 that it will delay work until the new Administration is in place. One of the Agency’s first steps was the drafting of a guidance document: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs). The purpose of this article is to examine the position of the FDA as set out in the draft guidance, taking note of the discussion paper released in January 2017, and propose how the FDA could move forward with minimal impact on medical laboratories while accomplishing the accountability and transparency the public deserves. More >>

European News

  • Europe: Latest timings on the new Regulations for medical devices and IVDs
  • Europe: Products whose principal intended action (depending on PAC present in cranberry) is to prevent or treat cystitis, should not be medical devices
  • Europe: Joint Action on Market Surveillance of Medical Devices launched at 39th CAMD meeting
  • Europe: Eucomed and EDMA formally merge to create MedTech Europe
  • France: Advice for French manufacturers if their Notified Bodies cease operations
  • Sweden: Responsibility for Notified Bodies to transfer to MPA from SWEDAC
  • Switzerland: Grace period for manufacturers affected by the de-designation of their Notified Body
  • UK: Significant fee increases proposed by MHRA to aid cost recovery

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North American News

  • Canada: Non-eCTD electronic-only format to be used for medical device regulatory activities
  • Canada: Scientific and clinical content of licence applications for dermal fillers set out in new guidance document
  • Canada: List of recognised standards for medical devices has been updated
  • USA: 21st Century Cures Act signed into law
  • USA: Most powdered medical gloves are now banned in the USA
  • USA: Pedicle screw systems, including semi-rigid systems, are renamed and reclassified
  • USA: Computerised cognitive assessment aids for concussion have been classified into Class II (special controls)
  • USA: Class II classification deemed appropriate for the Eustachian tube balloon dilation system
  • USA: Paediatric hospital beds are renamed paediatric medical cribs; separate classification created for medical bassinets; special controls established
  • USA: Neurovascular mechanical thrombectomy device for acute ischaemic stroke treatment classified into Class II
  • USA: Up-classification of specialised surgical instrumentation for use with urogynaecologic surgical mesh
  • USA: Reclassification of certain microbiology devices and designation of special controls
  • USA: Post-marketing safety reporting requirements for combination products
  • USA: Determining when a tobacco product is a drug, device or combination product
  • USA: New import data requirements for FDA-regulated products
  • USA: Post-market management of cybersecurity in medical devices
  • USA: Risk:benefit factors to consider in compliance and enforcement decisions
  • USA: Factors to consider when making benefit:risk determinations for IDEs
  • USA: Public notification of emerging post-market medical device signals
  • USA: Labelling for permanent, hysteroscopically-placed tubal implants for sterilisation
  • USA: Guidance published on pre-market notification submissions for Magnetic Resonance Diagnostic Devices
  • USA: Mitigating the risk of cross-contamination from the use of flexible gastrointestinal endoscopes
  • USA: Clinical considerations for neurological devices targeting disease progression and clinical outcomes
  • USA: Guidance published on the regulation of accessories to medical devices
  • USA: Updated guidance for manufacturers on Medical Device Reporting
  • USA: FDA relaxes certain conditions for sale for air-conduction hearing aids
  • USA: cGMP requirements for combination products - supplemental guidance published
  • USA: Guidance published for IRBs, investigators and sponsors on the use of electronic informed consent
  • USA: Q&A on medical product communications that are consistent with FDA-required labelling
  • USA: Clarification drafted on acceptable manufacturer communications with payors, formulary committees and similar entities
  • USA: Advice is drafted on how to prepare a Pre-Request for Designation (Pre-RFD)
  • USA: Addition of safety statement proposed for product labelling of certain ultrasonic surgical aspirator devices
  • USA: Comments solicited on proposed recommendations for bone anchor 510(k) submissions
  • USA: FDA and CMS Parallel Review programme to continue
  • USA: Modifications to the list of US FDA-recognised standards
  • USA: CDRH publishes proposed guidance development lists for fiscal year 2017

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Central & South American News

  • Argentina: Aesthetic use products to be subject to sanitary registration requirements
  • Brazil: Clinical data requirements for innovative and certain high-risk medical devices
  • Brazil: Changes proposed to GCP inspections
  • Brazil: Inmetro further extends compliance date for new conformity assessment procedures
  • Colombia: Draft labelling requirements for IVD and other reagents

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Asia, Africa & Middle East News

  • Asia: Raft of guidance documents endorsed at 21st Annual Meeting of the AHWP
  • Australia: Regulatory reform consultations
  • Australia: MTAA appoints new CEO
  • China: Priority review and approval procedure effective 1 January 2017
  • China: Tighter rules proposed for the management of medical device recalls
  • China: Administrative measures on adverse event monitoring and evaluation re-drafted
  • China: Lower import tariffs for 30 medical device types
  • Korea: IVD technical documentation review requirements now in force
  • Korea: Process for preliminary review of medical device advertisements
  • Korea: Scope and application of medical device consignment certification/notification
  • Korea: Harmonisation of specifications for self-test blood glucose monitoring systems with international standards
  • Malaysia: Guidance published on change of ownership for device registration
  • Malaysia: Guidance on change notifications for registered medical devices
  • Malaysia: Minor changes made to Conformity Assessment Procedures for medical devices approved by recognised countries
  • Malaysia: Draft guidance circulated on drug-device/device-drug combination products
  • Myanmar: Trade restrictions lifted on hospital equipment
  • Russia: List of implantable medical devices revised and expanded
  • Saudi Arabia: Storage, handling and transportation recommendations for medical devices
  • Saudi Arabia: Process for importing medical devices in national emergency situations is clarified
  • Saudi Arabia: Guidance on the importation requirements for personal use and custom-made medical devices
  • Saudi Arabia: Guidance on obtaining an importation licence and clearance for a non-medical IVD
  • South Africa: Department of Health publishes regulations on medical devices and IVDs
  • South Africa: Guidance on oversight and monitoring of clinical trials
  • Taiwan: Partial amendment of Regulation for Registration of Medical Devices drafted
  • Thailand: Medical device reporting criteria, methods and conditions are stipulated

More >>

Reference Section

  • Overview of the medical device regulations in Panama: a Competent Authority perspective

More >>