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Journal of Medical Device Regulation Issue Headlines - August 2012

European regulatory intentions do not always match implementation

Ensuring that a company fulfils its requirements under the European medical device regulations can be a difficult process, especially when there are ambiguous and sometimes opposing views on how the legislation should be drafted and interpreted. Kanwal Jit Singh has performed a gap analysis of the medical device regulatory requirements to identify areas where regulatory intentions do not appear to fit with the legislation and recommended implementation practices. This article focuses on four main areas where confusion exists and action is needed to clarify and resolve the issues: the definition of a medical device; the sub-division of Class I devices; the classification of active devices and devices incorporating a medicinal substance; and ‘placing on the market’ and ‘state-of-the-art’ in the third edition of EN 60601-1. More >>

Practical experiences of registering a Chinese Class III medical device

With the fast growing medical device market in China, an increasing number of foreign manufacturers are keeping a watchful eye on the industry. As compared to Western countries, China takes the application and approval process for imported medical devices to a whole new level of complexity. Language barriers and cultural differences present further obstacles for device manufacturers. Christina Søholm provides a general introduction to the Chinese legal environment and the product registration procedure for Class III products under the Chinese classification rules based on the experiences of a medical device manufacturer located in the European Union. More >>

Medical devices and the Regulated Product Submission

For many years, industry and regulators have recognised the need for electronic submissions in order to reduce the administrative, financial, logistical and environmental burdens that are currently imposed by working with paper-based submissions. The switch to a standards-based, end-to-end, fully electronic regulatory submission management environment is slowly taking place, and the US Food and Drug Administration expects to receive the first Regulated Product Submissions (RPSs) as early as next year. As the RPS is set to become the standard for electronic regulatory submissions for medical devices, Val Theisz and Tom Smith explain what an RPS actually is, and then provide some practical advice to device manufacturers who may be, or perhaps should be, preparing to implement them. More >>

A critical examination of MEDDEV 2.12-1 rev 7 on medical device vigilance

MEDDEV 2.12-1 rev 7, Guidelines on a Medical Devices Vigilance System (March 2012) replaced MEDDEV 2.12-1 rev 6 (December 2009) on 15 June 2012. The stated changes to the Guidelines are the addition of two new Reports Forms (Annex 6 and Annex 7) and the amendment of two existing Report Forms (Annex 3 and Annex 4). However, other changes have also been introduced. Haroon Atchia examines critically the differences between the two editions and evaluates the impact of these differences on manufacturers. The article also identifies areas within the Guidelines where confusion and ambiguity remain, such as Annex 8 on the National Competent Authority Report format, and the terminology used throughout the document. More >>

‘The tax man cometh’ - A regulatory perspective on the new US medical device excise tax

A 2.3% excise tax on the sale of specified medical devices sold in the USA will take effect on 1 January 2013, with the first payment due to the Internal Revenue Service on 29 January 2013. Readers may be asking why this topic is being discussed in the Journal of Medical Device Regulation since taxation is outside the scope of practice for the regulatory affairs department. In this instance, it is important to understand that the taxation is closely tied to how the device is regulated by the Food and Drug Administration, and it is regulatory affairs professionals who truly understand which medical devices may be subject to taxation. Rosina Robinson provides an overview of the new requirements from the medical device regulatory perspective. More >>

Comparison of the medical device regulatory requirements in the European Union and India

Different countries have different regulations for approving a medical device and providing authority to the manufacturer to market the product. In this article, Bijayata Upadhyay examines the similarities and differences between the regulations to be fulfilled by medical devices in the European Union (EU) and India. The comparison between the highly regulated market of the EU and the far less regulated market in India reveals several differences, particularly with respect to the technical documentation requirements. More >>

European Update

  • Denmark transposes Directive 2011/100/EU on vCJD assays
  • European Parliament’s Resolution on PIP case
  • France’s AFSSaPS becomes ANSM
  • New advertising rules for devices and IVDs in France
  • Italy sets up breast implant registries
  • Fees charged by Spain’s AEMPS increase by 1%
  • Sweden transposes Directive 2011/100/EU on vCJD assays
  • Sweden publishes introduction to MEDDEV 2.1/6 on standalone software
  • Swedish guidance documents for Class I and custom-made devices
  • Procedure for foreign government inspections in Switzerland
  • UK releases guidance for Notified Bodies on IVDs for self-testing

More >>

US Update

  • Device provisions of the Food and Drug Administration Safety and Innovation Act of 2012
  • PMAs/PDPs for certain pre-amendments Class III devices
  • FDA proposes unique device identification (UDI) system for medical devices
  • Proposed reclassification of implanted blood access devices
  • Guidance documents for computer-assisted detection devices
  • Providing early feedback on device submissions: draft guidance
  • Draft guidance on paediatric uses of x-ray imaging devices
  • Draft guidance on transferring to another Institutional Review Board
  • Medical device recalls increased by 160% in the first quarter of 2012
  • Comments sought on requests for 510(k) exemptions
  • Protected broadband spectrum for Medical Body Area Networks
  • Massachusetts relaxes ban on industry gifts

More >>

International Update

  • TGA fees and charges rise by 5.6%
  • Australia up-classifies implanted hip, knee and shoulder joints
  • Australian Therapeutic Goods Advisory Council to be created
  • Brazil to simplify approval process for clinical research
  • Brazil publishes guide to IVD regulation
  • Supporting evidence for Class III / IV device licence applications: Canadian guidance
  • Health Canada to draft guidance on drug/device interface
  • Health Canada launches phase II of Summary Basis of Decision project
  • Re-registration necessary following China’s device classification changes
  • China plans to impose further labelling requirements on imported devices
  • Unannounced inspections of device manufacturers in China
  • India strengthens the regulation and monitoring of clinical trials
  • India clarifies import procedure for diagnostic kits/reagents
  • Definition of a medical device and an in vitro diagnostic: final GHTF guidance
  • Non-conformity grading system for regulatory audits: draft GHTF guidance
  • Quality control of ‘special medical equipment’ in Korea
  • Malaysia: transitional arrangements for new device regulations
  • Singapore streamlines market access for lower risk devices
  • Good Manufacturing Practice: Taiwan to recognise ISO 13485: 2003
  • Taiwan to permit sale of Class I devices through ‘virtual channels’
  • Ukraine proposes revision of Technical Regulation 536 of 2008 on medical devices

More >>

Environment Update

  • Canadian province recycling regulation now applies to medical devices
  • Turkey drafts regulation to control waste electrical and electronic equipment (WEEE)

More >>

Standards Update

  • China drafts standards for contact lenses
  • Harmonised EU standards
  • Amendment 1 of third edition of IEC 60601-1 published
  • New dentistry standard ISO 20126: 2012 published
  • New ISO standard for spectacle frames
  • Jordan’s standards organisation joins CENELEC
  • Korea proposes revision of certain device standards and specifications
  • Kyrgyzstan becomes Partner Standardization Body of CEN

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: medical device regulations in Thailand
  • Elemental Essentials: examples of product classifications in Europe
  • Continuing education: University Masters courses for the medical device professional

More >>