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Medical device news from the WHO

WHO resolution number 20; conference; forum; and request for input for the new edition of the regulations book.

1.       WHA67 resolution 20

The World Health Assembly (WHA) is the supreme decision-making body for WHO. The 67th WHA met 19 to 24th of May, it was  attended by delegations from all 194 Member States. It approved the resolution 20 named: Regulatory system strengthening for medical products. (For the purpose of this resolution, medical products include medicines, vaccines, diagnostics and medical devices).

It states the importance of the regulations of medical devices as one of the medical products, for better public health outcome and to increase access to safe, effective and quality medical products; and acknowledges the need to support the area of medical devices.

The complete text of the Resolution in English (other offical versions on request). Some important notes in reference to medical devices are the following :
##It URGES Member States: to strengthen national regulatory systems, to engage in global, regional and subregional networks of national regulatory authorities,  and to promote international cooperation, as appropriate,
##It REQUESTS the Director-General WHO: to prioritize support for establishing and strengthening regional and subregional networks of regulatory authorities, as appropriate, including strengthening areas of regulation of health products that are the least developed, such as regulation of medical devices, including diagnostics;  and to support the building-up of effective national and regional regulatory bodies and networks. To report in five years to the WHA on the implementation.

2.       ICDRA 2014  

The 16th International Conference on Drug Regulatory Authorities, will take place in Rio de Janeiro, 24 to 29 August,  and the main  program is for regulators only, the topic this year is Biosimilars, but due to increased interest,  from regulators, since last ICDRA, this year the programme includes one plenary session on Medical devices.

3.       IMDRF

The International Medical Devices Regulators Forum, will be 16 to 18 September 2014, in Washington DC. The full week program includes open stakeholders day, 17th September, and sessions for regulators only.  Also other events preconference and post-conference workshops.

4.    The current WHO book on “Medical devices regulations, overview and guiding principles” is being revised for a new edition, interested collaborators,  please send email to [email protected] .


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