Actualités

WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices

The WHO has just published the WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices, which was adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in  October 2016, and will be published as Annex 4 to its next report.It is available at http://www.who.int/medical_devices/publications/global_model_regulatory_framework_meddev/en/

This model document is "intended to provide guidance and support to WHO Member States that have yet to develop and implement regulatory controls relating to medical devices, as well as to jurisdictions that are continuing to improve their regulatory frameworks as they take steps to ensure the quality and safety of medical devices available in their countries". "Many countries have neither the financial resources nor the technical expertise to transition successfully from an unregulated market to a comprehensive medical devices law in a single programme. Instead, the Model recommends a progressive, or stepwise, approach to regulating the quality, safety and performance of medical devices. It provides guidance for a staged development of the regulatory system. This starts from basic-level controls -such as the publication of the law and resourcing the regulatory authority to undertake enforcement actions - then progresses to expanded-level controls - such as inspection of registered establishments and oversight of clinical investigations". Also, "regulation of medical devices does not take place in isolation, but should be coordinated with regulation of other medical products (e.g. medicines and vaccines) and wider government policy objectives".

Thus, this is very relevant for purchasers, procurement agencies, regulators.

(Seulement en anglais)