The US Food and Drug Administration has reopened until 7 September the public comment period for its proposal to lower the classification of certain neurological and physical medicine devices from Class III (high-risk) to Class II (medium-risk) 1,2 ...
The Tanzanian Food and Drugs Authority has stopped the import of certain standard disposable syringes with effect from 1 May 1 . The decision stems from the agency’s plan to limit and subsequently phase out the use of these products in favour of ...
The Tanzanian Food and Drugs Authority is asking manufacturers of 16 categories of medical devices to formally register their products with the agency as part of its efforts to establish a medtech regulatory framework for the country 1 . The first ...
The Australian health department has issued an order to clarify the classification of certain medical products that do not qualify as medical devices under the current regulations 1 . The Therapeutic Goods (Articles that are not Medical Devices) ...
The Australian Therapeutic Goods Administration has published templates under its new in vitro diagnostics framework that manufacturers can use to declare conformity with the relevant essential principles, classification rules and the appropriate ...
With devices becoming increasingly complex, competent authorities in the European Union must ensure there are sufficiently well-trained experts at notified body level, particularly for assessing innovative devices and for clinical trials. But ...
The UK Medicines and Healthcare products Regulatory Agency plans to begin a pilot programme in September that could lead to the development of a medical device driving licence (MDDL) for certifying the proficiency of healthcare workers in handling ...
The US-based ECRI institute says its Universal Medical Device Nomenclature System will be expanded to include "many additional terms" for software used with medical devices by the end of 2010 1 . The 2010 UMDNS currently contains 24,544 terms ...
The Global Harmonization Task Force has adopted a procedure that will open up membership of the group’s steering committee to representation from outside the European Union, the US, Japan, Canada and Australia. Regional members of the GHTF, such as ...
China’s State Food and Drug Administration and Brazil’s Anvisa healthcare regulatory agencies have met in Brasilia to further their collaboration in areas such as manufacturing inspections and information-sharing related to regulatory processes and ...
The Brazilian Health Surveillance Agency, ANVISA , will implement from 22 May new requirements for local and foreign manufacturers of certain medical devices to comply with Brazilian good manufacturing practices. The GMP requirements will apply to ...
The US Food and Drug Administration and the Federal Communications Commission have formed an initiative to improve the efficiency of their respective regulatory processes applicable to broadband and wireless-enabled medical devices 1 . The agencies ...
