Journal of Medical Device Regulation Issue Headlines - November 2014

Editorial: Is it right to keep pushing for a repeal of the US medical device excise tax?

There is little doubt that opponents of the USA’s 2.3% medical device excise tax are the most vocal but, perhaps surprisingly, the tax does still have supporters. One prominent advocate of the tax believes the ‘excise tax on medical devices should not be repealed’ and that ‘arguments against the tax don’t withstand scrutiny’. This Editorial helps uncover the facts behind the controversy. More >>

What is the legal basis of Recommendation 2013/473/EU and are Notified Bodies, and consequently certified manufacturers, bound by it?

Volker Lücker questions how European Recommendation 2013/473/EU on the audits and assessments performed by Notified Bodies in the field of medical devices should be understood and what the legal context of this Recommendation actually is. In particular, he questions whether Notified Bodies – and therefore, at least indirectly, all certified manufacturers of medical devices – are bound by this Recommendation. The article investigates the nature of a Recommendation in general, before examining the nature of this specific Recommendation (2013/473/EU). It then considers the resulting consequences for any rights and obligations of the Notified Bodies, taking Germany as an example. More >>

Potential for abuse and mis-use of Commission Recommendation 2013/473/EU by Notified Bodies and the implications for medical device economic operators

Commission Recommendation 2013/473/EU on the audits and assessments performed by Notified Bodies in the field of medical devices was adopted by the European Commission on 24 September 2013. The Recommendation covers Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC and is intended to ensure proper verification of conformity assessments performed by Notified Bodies by tackling frequent shortcomings of audits, assessments and unannounced audits. The Recommendation distinguishes between product assessments and quality system assessments performed by Notified Bodies, as well as unannounced audits to verify continuous compliance with legal obligations. The purpose of Haroon Atchia’s article is to explore the content of the Recommendation and expose areas of possible abuse that could lead to the exploitation of economic operators in the field of medical devices. More >>

An industry perspective on the major changes in the regulatory environment for medical devices imported into China

In March 2013, China initiated sweeping national reforms of the regulation of therapeutic products. The previous State Food and Drug Administration was restructured and elevated to form the China Food and Drug Administration. Around this time, China also became a member of the International Medical Device Regulators Forum. This signalled an increased attention on international harmonisation of China’s regulations. Regulatory reform in China is extensive and is proceeding at a fast pace. Starting at the top tier medical device regulation, the revised Regulation for the Supervision and Administration of Medical Devices leads to top-down changes both in regulatory processes and in technical requirements. Where some reforms result in simplified processes and shorter timelines, others lead to requirements for more extensive technical documentation, and clinical evidence – including increased expectations for in-China trials. For international manufacturers it will be essential to keep abreast of the developments in China and to be prepared to be flexible as the regulatory framework continues to develop. This is challenging when the only official versions of regulations are in Mandarin. This article by Lucy Xiao, Davey Dehui Han and Arthur Brandwood seeks to capture the essence of the reform and to analyse the implications of new provisions on imported devices. More >>

European News

  • Denmark announces new rules for people collaborating with medical device companies
  • Will medical device policy move back to the European Commission’s DG Enterprise?
  • John Wilkinson elected Chair of Competent Authorities for Medical Devices (CAMD) group
  • Consultation on EU implementation of the Minamata Convention on mercury
  • Safety of metal-on-metal joint replacements determined by SCENIHR in final opinion
  • SCENIHR consults on safety of dental amalgam and alternative dental restoration materials
  • Points to consider on clinical evidence for medical devices in Europe highlighted in new Dutch report
  • Dominique Martin appointed Director General of ANSM in France
  • New President and Vice-President of German BfArM announced
  • Implant cards will be compulsory for certain products in Germany from 1 October 2015
  • JFC solicits comments on first trial regulation studies in Germany
  • No increases in medical device fees in Ireland proposed for 2015
  • Irish guidance on clinical investigations published
  • Italy clarifies which healthcare facilities may conduct clinical research on active implants
  • Switzerland updates Information Sheet on clinical trials of medical devices
  • UK proposes to introduce a fee for issuing Certificates of Free Sale

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North American News

  • Canada updates list of combination product classification decisions
  • New licensing requirements for lancing devices and blood glucose monitoring systems in Canada
  • Amendments made to Canadian Bill C-17 that addresses key areas of concern regarding patient safety
  • Canadian regulatory changes for non-corrective contact lenses and labelling of Class II devices
  • Health Canada updates list of recognised standards for medical devices
  • FDA medical device user fees for Fiscal Year 2015
  • US FDA classifies implantable transprostatic tissue retractor system into Class II
  • Down-classification of implanted blood access devices takes effect in USA
  • US classification of dengue virus nucleic acid amplification test reagents
  • Tryptase test systems classified into Class II by US FDA
  • FDA approves classification of haemoglobin A1c test systems into Class II
  • Final order classifying certain haematology and pathology devices published
  • Reclassification of salivary stimulatory systems proposed
  • Reclassification of iontophoresis devices intended for any other purposes is proposed
  • EPPG devices and PSAs proposed for reclassification into Class II
  • Unique Device Identification: guidance documents; extended compliance date for contact lenses and IOLs
  • Final guidance provided on the interpretation of the USA’s custom device exemption
  • US guidance published on studies to establish analytical and clinical performance of HMMDs
  • Rationale for FDA’s decisions on IDE clinical investigations provided in new guidance document
  • US guidance distinguishes between medical device recall and medical device enhancement
  • Design considerations for home-use devices: final US guidance released
  • US publishes guidance on in vitro companion diagnostic devices
  • Guidance finalised on evaluating substantial equivalence in pre-market notifications
  • Evaluation of sex-specific data in medical device clinical studies: US guidance finalised
  • Recommendations for cybersecurity management in medical devices
  • FDA guidance answers questions on CDRH appeals processes
  • FDA intends to exempt certain Class II and Class I reserved devices from 510(k) requirements
  • Guidance drafted on de novo classification process
  • Regulatory oversight of LDTs is subject of two new US draft guidance documents
  • US proposes to clarify policy for fluoroscopic equipment requirements
  • Concerns over content of pre-market submissions for flow cytometric devices prompts drafting of guidance by FDA
  • Candidates sought to participate in pilot for qualification of medical device development tools
  • Modifications to the list of US FDA-recognised standards

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Central & South American News

  • Argentina publishes latest fees for medical device registration
  • Labelling requirements for devices containing natural rubber latex introduced in Argentina
  • Argentina postpones implementation of new distribution/commercialisation rules
  • Devices for dosing and administration of a drug may be exempt from product registration in Brazil
  • Brazil proposes to consolidate criteria for conformity assessment procedures
  • Brazil drafts Resolution on clinical trials involving medical devices
  • ANVISA holds consultation on labelling for medical devices containing natural rubber latex
  • HIV self-testing and non-IVD marketing authorisation requirements under development in Brazil
  • ANVISA launches health products monitoring programme
  • Ecuador publishes Technical Regulations for dentistry products and electromedical equipment
  • Ecuador publishes Technical Regulation for external limb prostheses and external orthoses
  • Mexico releases new draft guidance on submission of technovigilance reports

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Asia, Africa & Middle East News

  • AHWP solicits comments on adverse event reporting timeframes guidance
  • Australia increases scrutiny of medical device applications using evidence from certain European Notified Bodies
  • Australian medical device and IVD manufacturers will finally be given a level playing field
  • TGA in Australia to review all urogynaecological surgical mesh products listed in the ARTG
  • Australia looks to address problems with implementation of new IVD Regulations
  • Australian TGA publishes key performance indicators for first half of 2014
  • Medical Technology Association of Australia to appoint new Chair
  • Five new Chinese Administrative Measures were implemented in October 2014
  • China proposes use of generic names for medical devices
  • China releases draft guidance documents on clinical trials for medical devices and IVD reagents
  • Common principles and rules drafted for medical device circulation in Eurasian Economic Union
  • Ghana tightens import controls to prevent unsafe or counterfeit products reaching the market
  • India amends medical device regulations
  • Medical device clinical trials in India to follow same procedures as drug trials
  • Japan proposes to amend standard for biological ingredients used in medical devices
  • Malaysia abolishes list of medical devices exempt from registration
  • Philippines proposes to adopt ASEAN Common Submission Dossier Template
  • Russia requests comments on proposed classification system for medical devices
  • Singapore’s Change Notification process for FSCAs updated on 1 October 2014
  • Singapore proposes amendments to contact lens grouping criteria
  • South Africa opens consultation on draft Essential Principles and general guidelines concerning proposed new medical device and IVD Regulation
  • South Korea revises standards and specifications for electromagnetic safety of medical devices
  • Amendments proposed to South Korea’s controls on medical device clinical investigations

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Global Interest News

  • Final documents on software and auditing issued by the IMDRF
  • IMDRF publishes final Tables of Contents for IVD and non-IVD pre-market applications
  • Feedback requested on NCAR exchange criteria and report form proposed by the IMDRF
  • Current status of the third revision of ISO 13485

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Reference Information

  • Overview of the medical device regulatory requirements in Hong Kong

More >>