Browse English Issue Headlines - May 2019

The US Breakthrough Devices Program and the Safer Technologies Program

The Breakthrough Devices Program (BDP) and the Safer Technologies Program (STeP) are Food and Drug Administration (FDA) programmes intended to incentivise development of medical devices that are safer or more effective than currently available devices. The BDP is a codified, established programme that incentivises development of medical devices that more effectively treat or diagnose life-threatening or irreversibly debilitating diseases or conditions. STeP, on the other hand, is a programme proposed by the FDA to incentivise development of medical devices that offer substantial safety innovations but do not otherwise qualify for the BDP, for example because they treat less serious diseases. This article describes what each programme is intended to achieve and the current status of each. The article begins with a description of the BDP, and uses the BDP as a starting point for discussing the likely framework for STeP. More >>

From the Directives’ ERs to the new Regulation’s GSPRs: revolution or evolution in the regulation of medical devices in the European Union?

A new regulatory system for medical devices is being implemented in the European Union. The old Directives on medical devices are being replaced by a single Regulation on medical devices (Regulation (EU) 2017/745). Manufacturers will have to achieve compliance with the new General Safety and Performance Requirements (GSPRs), which replace the Essential Requirements (ERs) of the Directives. The GSPRs set out safety and performance requirements for medical devices and must be complied with irrespective of the risk class of the device. Almost all of the ERs contained in the Directives are retained in the GSPRs of the Regulation; this article focuses on the new requirements introduced in Annex I to Regulation (EU) 2017/745. More >>

Current status of the ASEAN Medical Device Directive

The Association of South East Asian Nations (ASEAN) is composed of 10 member states: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam. The healthcare sector is a high priority focus area under the ASEAN Economic Community (AEC), a regional economic integration agenda under ASEAN, for a combined market of over 622 million people. The ASEAN Medical Device Directive (AMDD) contains a unified set of guidelines for various aspects of medical device regulation, applicable to all of the 10 member states. A harmonised system for medical device registration in the region reduces technical barriers for medical device manufacturers marketing their products in the region. These improvements can boost productivity to bring enhancements in the quality and range of products and services, to the benefit of consumers and users. This article explores the current status of the transposition of the AMDD, what remains to be done, the timeframes, and the challenges that lie ahead. More >>

An overview of the medical device regulatory requirements in Thailand

The medical device regulations in Thailand have recently improved to provide a better safeguard for public health and to ensure that high-quality and effective devices reach Thai patients and consumers. This article provides an overview of Thailand’s regulatory requirements, including pre-market controls, post-market surveillance, clinical trials for medical devices, labelling and language requirements, and future changes. More >>

European News

  • Czech Republic: Form released for accessing online reimbursement system
  • EU: Corrigenda published to Regulations 2017/745 and 2017/746
  • EU: MDCG clarifies scope of clinical evaluation consultation procedure
  • EU: EMA issues Q&A document to assist with implementation of Article 117 of Regulation (EU) 2017/745
  • EU: MDCG issues new and updated guidance on UDI
  • EU: Details of EUDAMED nomenclature system unveiled
  • EU: More EUDAMED guidance on timelines for registration of device data elements, and registering legacy devices
  • EU: Commission’s rolling plan on MDR/IVDR implementation updated again
  • EU: Manual on borderline and classification issues updated
  • EU: Consultation held on benefit-risk assessment of phthalates in certain medical devices
  • Finland: Medical device control being transferred from Valvira to Fimea
  • France: Submission of files to the CNEDiMTS for reimbursement purposes must be done electronically
  • Germany: National implant register to be established
  • Portugal: Presentation of medical device code in NHS contracting procedures; development of an Integrated Medical Device Monitoring System
  • Switzerland: Requirements for ordering Certificates of Free Sale have been modified
  • UK: Guidance on virtual manufacturing of medical devices recently updated
  • UK: Brexit update

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North American News

  • Canada: Medical device fees increased by 2% from 1 April 2019
  • Canada: ‘Medical Devices Regulations’ updated to refer to 2016 edition of ISO 13485
  • Canada: Public to have access to clinical information on drugs and devices
  • Canada: Consultation held on draft guidance concerning software as a medical device
  • Canada: Publication of Draft Health Canada IMDRF ToC for Medical Device Applications Guidance
  • Canada: Publication of updated list of recognised standards for medical devices
  • USA: New acting FDA Commissioner
  • USA: CDRH undergoes period of reorganisation
  • USA: Ventilatory electrical impedance tomograph classified into Class II (special controls)
  • USA: Posterior cervical screw systems become Class II devices
  • USA: In vitro diagnostic devices for Bacillus species detection placed in to Class II
  • USA: Class II classification for software applications for contraceptives
  • USA: Auto titration device for oral appliances is classified into Class II
  • USA: Class II classification for the transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions
  • USA: Devices to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens are Class II devices
  • USA: Steps to reduce risks from use of surgical staplers for internal use and implantable staples
  • USA: Certain flow cytometer instruments to be exempted from 510(k) review
  • USA: Finalised list of accessories distinct from other devices and suitable for Class I
  • USA: Safety and performance based pathway described in final guidance
  • USA: Resources for implementing final rule on human subject protection; acceptance of data from clinical investigations for medical devices
  • USA: Certain unclassified medical devices are exempt from 510(k) requirements
  • USA: Guidance updated on post-market safety reporting for combination products
  • USA: New guidance covers issuing of public warnings about voluntary recalls and notification of recalls
  • USA: Guidance on evaluation of devices used with regenerative medicine advanced therapies
  • USA: Concept and principles of the least burdensome provisions are updated in guidance
  • USA: Updated guidance on devices containing materials derived from animal sources
  • USA: New guidance addresses coordinated development of antimicrobial drugs and AST devices
  • USA: Draft principles of pre-market pathways for combination products
  • USA: Standardised process for providing non-binding feedback after certain FDA device establishment inspections has been proposed
  • USA: Draft guidance on initiating voluntary product recalls
  • USA: Draft guidance recommends non-clinical testing and clinical considerations for implanted Brain-Computer Interface devices
  • USA: Review and update of device establishment inspection processes and standards
  • USA: Questions and answers drafted on a risk-based approach to monitoring clinical investigations
  • USA: Draft guidance issued on technical performance assessment of quantitative imaging in device pre-market submissions
  • USA: Technical considerations are proposed for non-clinical assessment of medical devices containing nitinol
  • USA: Proposed regulatory framework for modifications to artificial intelligence-/machine learning-based software as a medical device
  • USA: Modifications to the list of US FDA-recognised standards
  • USA: GUDID temporary grace period extension ends; HL7 SPL processing window reduced
  • USA: Clarification provided on difference between servicing and remanufacturing of medical imaging devices

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Central and South American News

  • Argentina: Procedure for requesting an import authorisation for a medical product
  • Argentina: Regulatory controls established for sunglasses
  • Brazil: Class I medical devices and IVDs no longer require full registration, only notification
  • Brazil: Extended comment period on proposed ‘classification’ of medical devices as single use or reusable
  • Brazil: Reprocessing of products used in cardiac procedures continues to be permitted
  • Brazil: ANVISA amends IN 03/2015 to add IVD ‘systems’
  • Ecuador: Second revision of standard on natural rubber latex male condoms drafted
  • Honduras: Regulations to control medical devices and related establishments are drafted
  • Mexico: Mexican Official Standard on excimer laser ophthalmic surgery practices drafted

More >>

Asia, Africa and Middle East News

  • Australia: Proposed reclassification of spinal implantable medical devices
  • Australia: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
  • Australia: Consultation held on regulation of software, including Software as a Medical Device
  • Australia: Proposed alignment with EU rules for classification of transient/short-term surgically invasive devices used in direct contact with the heart, CCS or CNS
  • Australia: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin
  • Australia: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media
  • Australia: Changes to the classification of active implantable medical devices and their accessories are proposed
  • Australia: New classification rule proposed for devices that administer medicines or biologicals by inhalation
  • Australia: Guidance on use of market authorisation evidence from comparable overseas regulatory bodies for medical devices
  • Australia: ‘Action Plan for Medical Devices’ is released
  • China: Draft amendments to the ‘Regulations for the Supervision and Administration of Medical Devices’
  • Hong Kong: Proposed Guidance Notes for the listing of Local Responsible Persons
  • India: Eight medical device types to be classed as drugs from April 2020
  • India: Six medical device Quality Control Orders circulated for public comment
  • Japan: Fee increases took effect on 1 April 2019
  • Japan: MDSAP participation extended until the end of March 2020
  • Korea (Republic of): ‘Medical Device Act Enforcement Regulation’ to be amended
  • Korea (Republic of): Proposed amendments to ‘Regulations on standard specification of medical devices’
  • Malaysia: ‘How to apply for medical device registration under Medical Device Act 2012 (Act 737)’ is updated
  • Malaysia: New guidance on notification of medical devices for special access
  • Malaysia: Draft guidance issued on notification of export-only medical devices
  • Philippines: Labelling requirements drafted in line with ASEAN MDD
  • Philippines: Rules are drafted in line with the AMDD for authorising IVDs placed on the market in the Philippines
  • Philippines: Guidelines drafted on the conduct of clinical investigations of medical devices for human subjects
  • Saudi Arabia: Five new guidance documents released
  • Singapore: Guidance updated on establishment licensing, product registration and change notification
  • Singapore: Launch of Online Safety, Compliance Application and Registration System (OSCAR)
  • Taiwan: Proposed changes to classification names/descriptions in The Regulations for Governing the Management of Medical Device
  • Uganda: Draft Uganda Standard for umbilical cord clamps created
  • Uganda: New standard drafted for medical ultrasound gel
  • Uganda: Use of the ISO 7886 and ISO 7864 standards for hypodermic syringes and hypodermic needles
  • Uganda: Six new DUSs on surgical instruments and materials adopted
  • Vietnam: New regulatory requirements for medical devices

More >>

Global Interest News

  • EU/US: Cooperation on development of UDI database specifications
  • IMDRF: Assembly and technical guide for IMDRF ToC submissions
  • IMDRF: Clinical evaluation documents updated and circulated for comment
  • ISO: Updated standards on packaging for terminally sterilised medical devices
  • WHO: Draft policy on remaining shelf-life of medical products

More >>