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Browse English Issue Headlines - February 2006

GHTF'S NCAR Program: Analysis of Statistics and Performance

The National Competent Authority Report (NCAR) Program established by the Study Group 2 (SG2) of the Global Harmonisation Task Force, has now been running for approximately six years. The programme is designed to facilitate the exchange of information between National Competent Authorities (NCAs) or national regulatory agencies regarding corrective actions or other issues associated with serious risks to safety associated with the use of medical devices. The programme started as a small pilot study of exchange between a small number of NCAs but has grown dramatically. From January to November 2005, 180 reports had been exchanged among 20 participants. The programme is expected to grow further as the number of participants increases. In this article, Jorge E Garcia relates some of the history, philosophy and method of operation of the NCAR Program and analyses its participation statistics and its performance against qualitative measures. The conclusion is that the NCAR has already proven to be an extremely useful post-market regulation tool and that, alongside guidance on mandatory adverse event reporting, the NCAR Program may well be one of SG2's most significant achievements. More >>

Entitlement of Degree of Safety of Medical Products

All medical device manufacturers should take note of the fact that the degree of safety that the public is entitled to expect in a product under Article 6 of the European Product Liability Directive is not contingent on the possibility of avoiding harmful characteristics. As an education exercise, much can be learnt from a judgement by Mr Justice Burton back in March 2001, which concerned 114 people who became infected with Hepatitis C through blood transfusions between 1 March 1998 (the date on which the UK Consumer Protection Act came into force) and 1 September 1991 (when the UK National Blood Authority introduced screening for Hepatitis C). The Consumer Protection Act, which implemented the European Product Liability Directive in the UK, imposes strict liability on producers of defective products that cause injury (in this case, the National Blood Authority), although it does not consider whether or not the producer is negligent. From a legal standpoint, this was the first significant case brought under the Consumer Protection Act and consequently tested the 'strict liability' regime where a consumer does not have to prove fault or negligence. In this article, Haroon Atchia discusses various important issues raised by this case. More >>

Bar Coding of Medical Devices

Bar coding of medical devices contributes towards improving patient safety and supply chain efficiency. However, contrary to the situation for pharmaceuticals, very few regulatory bodies have, to date, released Directives for automatic product identification. In her article, Ulrike Kreysa describes how the healthcare industry has recently recognised the need for global standards in healthcare and why, in May 2005, leading global companies from the pharmaceutical and medical device industry formed the global GS1 Healthcare User Group (GS1 HUG[TM]). Its mission is to lead the healthcare industry to the effective utilisation and development of global standards, with the primary focus on automatic identification to improve patient safety. While developing global voluntary guidelines it is important to consider carefully what information has to be stored for each type of medical device, as the guidelines cover a wide range of products with a wide range of patient safety issues. The diversity of medical devices on the market means a thorough analysis and an appropriate solution is needed. Automatic product identification through bar codes and, quite probably in the future, radio frequency identification technology tags helps to ensure a safe, secure and efficient healthcare supply chain. More >>

European Update

  • PharmMed Austria opened in January 2006
  • Organisational changes in the Danish Medicines Agency
  • Proposed amendments to the EU Medical Device Directives
  • Proposed EU regulation for advanced therapies
  • Review of the EU's ‘New Approach' system
  • Eucomed Position Paper on procedure packs
  • Revised definition of a medicinal product
  • Finnish National Agency for Medicines: fees for 2005–2007
  • New German ICD published
  • IMB Safety Notices
  • Incorrect classification of pressurised nasal sprays in Portugal
  • Reuse of single-use devices: INFARMED's position
  • INFARMED classification of products used to treat hyperkeratosis
  • Mercury in medical devices in Switzerland
  • General product safety in the UK
  • UK guidance on use of batteries and chargers for medical devices
  • Medical Device Alerts issued by UK MHRA
  • Ophthalmic medical devices: adverse incident reporting
  • Education programme on safe device use launched by UK MHRA

More >>

US Update

  • CFTR gene mutation system: classification
  • Low energy ultrasound wound cleaners: classification
  • Medical device reporting: technical amendment
  • Condoms and condoms with spermicidal lubricant: proposed classification
  • Tinnitus masker devices: proposed classification
  • Proposed reclassification of HSV (type 1, 2) serological assays
  • STED Pilot Program: updated guidance document issued
  • Guidance on recordkeeping for low power laser products
  • Nucleic acid IVDs for detection of microbial pathogens: draft guidance
  • Electromagnetic interference with medical telemetry systems
  • Problems associated with falsely elevated glucose readings
  • Information for laser pointer manufacturers
  • Guidance on high-intensity mercury vapour discharge lamps
  • New product codes for radiation-emitting electronic products
  • Medical device recalls
  • HDEs, special controls and environmental assessment exclusions
  • Investigation into the reprocessing of single-use devices
  • CDRH's medical device postmarket safety program

More >>


  • Excluded therapeutic goods in Australia
  • Reuse of single-use devices: transition period extended
  • Australia lists certain dental products as therapeutic goods
  • Clarification provided on regulation of alcohol wipes in Australia
  • Supply of HIV and HCV assays
  • Restocking and sterilisation of orthopaedic implant sets
  • Reducing the regulatory burden on businesses in Australia
  • Proposed amendments to Canada's Medical Devices Regulations
  • New Canadian labelling requirements for glucose monitors
  • Classification of contact lenses in Canada
  • Direct selling of medical devices in China
  • Illegal medical device advertisements in China: first summary
  • Use of Olympic symbols on device packaging and advertising
  • Phase 2 of Hong Kong's MDACS launched
  • India issues notifications on medical device regulation
  • Co-operation between the European Community and Brazil
  • Australia New Zealand Therapeutic Products Authority
  • Australian/New Zealand joint therapeutic advertising scheme
  • MoU between Canada and Australia
  • US/Canada MoU
  • US/Oman Free Trade Agreement signed
  • US/Thai free trade negotiations
  • GHTF guidance documents released for public comment
  • 10th AHWP meeting summary
  • Class I devices in Japan
  • New GCP updates in Japan
  • Japan urged to reform medical technology reimbursement
  • Korea enacts GCP regulations for devices
  • Korea's requirements for in vitro diagnostics
  • Medical Device Bill proposed in Malaysia
  • Romania joins CEN as full member
  • Medical device advertising in Thailand
  • New Thai regulation for radiology equipment being drafted
  • Draft Ministerial Announcements to be reworded
  • Thai FDA's Law Development Plan
  • Fee increase from the US Embassy in Thailand

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Environment Update

  • Hazardous substances in electrical and electronic equipment
  • Batteries and accumulators

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Standards Update

  • Harmonised EU standards
  • Technical Report for medical electrical equipment published

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: South Africa
  • Elemental Essentials: CMDCAS
  • Medical device and medicinal product demarcation in the EU
  • Conformity assessment procedures provided for in EU Directive 90/385/EEC

More >>