Browse English Issue Headlines - February 2015

Guest Editorial: New European Parliament, new Commission, another Presidency – where does the IVD legislation stand?

The European Diagnostic Manufacturers Association welcomes the revision of the in vitro diagnostics (IVD) legislation and its intention to strengthen the current approval system for IVDs. However, there is a need for legislation that is appropriate and fit for purpose, clearly taking into account the specificities of IVDs. In the new text, decision-makers should acknowledge that IVDs are non-invasive tests that never interact with patients, instead relying on biological samples to provide information that is subsequently used for diagnosis, screening, assessing predisposition and monitoring. The risks IVDs pose to patients is linked to the accuracy of this information and how it is used, not to the devices themselves. This is a marked distinguishing factor when it comes to legislative considerations and clearly separates IVDs from other medical devices, pharmaceuticals or other therapies. It also raises different considerations for the revision itself, including on topics such as the transition period, clinical evidence, post-market follow-up and transparency. More >>

Medical device reforms in China – mandatory in-China clinical trials for imported devices

The substantial regulatory reform that recently took place in China has introduced major updates to both pre- and post-market compliance requirements for medical devices and in vitro diagnostic reagents. One of the stated aims of these reforms, which came into effect on 1 October 2014, was to implement a system that significantly raised the standard on clinical safety requirements for high-risk medical devices in China. The revised legislation has now established a default position that requires mandatory in-China clinical trials for all imported Class II and III medical devices (unless specifically exempted). Manufacturers must, in addition, supply the Clinical Evaluation Report used to support the medical device approval in the country of origin. This article, which is written by Lucy Xiao, Davey Dehui Han and Arthur Brandwood, outlines the new in-China clinical trial requirements for imported medical devices, how clinical trials are conducted in China, and the key challenges facing non-Chinese manufacturers during this time of regulatory transition. More >>

The future for medical device vigilance – a European Competent Authority’s perspective

Medical devices and in vitro diagnostic (IVD) medical devices are of increasing importance to public health and the provision of medical care. It is essential that the regulatory system creates a framework for safe, effective and innovative medical devices, including IVDs. The European medical device vigilance system was set up under the Medical Devices Directives (93/42/EEC, 90/385/EEC and 98/79/EC) to minimise risks to the safety of patients, users and others. The Directives include requirements for medical device manufacturers to report certain types of events to the Competent Authority. This article by Anne Tobin explains the role of the Health Products Regulatory Authority in Ireland in the current vigilance system before looking at changes on the horizon for medical device vigilance in Europe as the Regulations on medical devices and IVDs are developed. More >>

The ‘Pharmaceuticals and Medical Devices Law’: an overview of new regulatory requirements in Japan

In November 2014, Japan’s Pharmaceutical Affairs Law (PAL) overseeing medical device registration requirements was replaced by the Pharmaceuticals and Medical Devices Law (PMDL). The PMDL contains several significant changes to the Japanese registration and approval process that affect manufacturers planning to market their devices in the country, as well as companies already selling their products there. The PMDL does not completely up-end the Japanese regulatory system established under the PAL but does implement many major changes to the country’s registration process. This article discusses all major aspects of device registration under the PMDL but focuses on nine key areas of the new Law that have changed from the PAL. More >>

European News

  • Denmark issues fee schedule for 2015
  • Commission proposes two new temporary exemptions from the RoHS 2 Directive affecting IVDs and ultrasound imaging systems
  • Guidance on the determination of potential health effects of nanomaterials used in medical devices - official opinion of the SCENIHR
  • Safety of metal-on-metal joint replacements with a particular focus on hip implants - official Opinion of the SCENIHR
  • NBOG update
  • Harmonised European standards
  • New Executive Committee elected for European Diagnostic Manufacturers Association (EDMA)
  • Germany drafts new Law on benefit assessments of medical devices
  • Spain increases medical device fees by 1% in 2015
  • UK appoints new Chair of Medicines and Healthcare products Regulatory Agency (MHRA)

More >>

North American News

  • Patient safety in Canada set to improve following passage of Vanessa’s Law
  • Electronic licence applications now accepted for Class III and IV medical devices in Canada
  • Canada prohibits use of certain mercury-containing medical devices and IVDs
  • US proposes re-classification of rigid pedicle screw systems and dynamic stabilisation systems
  • Class II classification for nucleic acid-based IVDs for the detection of MTB complex and associated gene mutations
  • FDA warns against using laparoscopic power morcellators to treat uterine fibroids
  • US FDA offers guidance on molecular diagnostic instruments with combined functions
  • US recommends standardised labelling statement for medical products that do not contain natural rubber latex
  • Guidance from FDA on improving the quality of infusion pumps and pre-market submission content
  • Design considerations for home-use devices: final US guidance updated
  • Establishing safety and compatibility of passive implants in MR environment: final US guidance released
  • Q&A guidance document drafted on procedures for transferring US 510(k) clearances
  • Study recommendations for radiation biodosimetry devices proposed in draft US guidance
  • USA drafts guidance on safe use of products used for irrigation through flexible gastrointestinal endoscopes
  • Clarification on definition and classification of medical device accessories provided in draft US guidance
  • CDRH will not be enforcing the regulation of low-risk devices that promote a healthy lifestyle according to new draft guidance
  • CDRH publishes proposed guidance development lists for 2015
  • UDI implementation and GUDID data submission update
  • UDI compliance deadline extended for certain single-use implants
  • New report analyses trends in US FDA product review processes
  • Final implementation plan on recommendations from independent assessment of US device submission review process
  • AdvaMed names new Chairman of its Board

More >>

Central & South American News

  • Brazil introduces automatic extensions for GGTPS compliance deadlines
  • ANVISA invites medical device companies to evaluate international GMP inspections
  • Mexico expands list of medical devices and other health products that do not require registration
  • Peru proposes amendments to medical device regulations
  • Peru proposes quality control verification requirements for batches of medical devices and pharmaceuticals
  • Peru drafts standard for metrological controls of non-invasive automated sphygmomanometers in line with international norms

More >>

Asia, Africa & Middle East News

  • AHWP finalises numerous documents and elects new leaders
  • Australia New Zealand Therapeutic Products Agency is officially scrapped
  • Australian device manufacturers may now utilise European conformity assessment certifications
  • Legal clarification that certain IVDs are medical devices in Australia
  • Australia hands over development of IVD terms to GMDN Agency
  • Australian government to conduct independent review of medical devices and medicines regulation
  • Medical Technology Association of Australia elects new Board of Directors
  • China agrees to streamline medical device approval process in trade talks with USA
  • Hong Kong solicits comments on application form and guidance for listing distributors under the MDACS
  • India releases draft Bill to strengthen clinical trial provisions and introduce specific device regulations
  • India proposes aligning GMP rules for medical devices and IVDs with international standards
  • India relaxes foreign ownership rules for medical device manufacturers
  • Japan revises manufacturing and quality control requirements for medical devices and IVDs
  • Japan issues Notification concerning marketing applications for combination products
  • New Zealand’s Medsafe has relocated
  • Medical device registration applications in Russia must now include a six digit classification code
  • Saudi Arabia releases guidance on importing devices intended for demonstration or training purposes
  • Saudi guidance published to assist in importation of international quality and efficiency samples
  • Singapore to amend import consignment testing requirements for condoms

More >>

Global Interest News

  • Current status of the third revision of ISO 13485
  • Update on ISO 4074:2014 concerning natural rubber latex male condoms
  • Manufacturers are now invited to participate in Medical Device Single Audit Program pilot

More >>

Reference Section

  • Country overview: Argentina
  • Meeting report: Drug-Device Combination Products
  • Book review: Biointegration of medical implant materials (science and design)

More >>