Medical devices

Regulations

Regulation is primarily concerned with enabling patient access to high quality, safe and effective medical devices, and avoiding access to products that are unsafe. When appropriately implemented, regulation ensures public health benefit and the safety of patients, health care workers and the community.

WHO has a mandate, as outlined in the World Health Assembly (WHA) Resolution 60.29 “to encourage member states to draw up national or regional guidelines for good manufacturing and regulatory practices, to establish surveillance systems and other measures to ensure the quality, safety and efficacy of medical devices and, where appropriate, to participate in international harmonization”.


67th World Health Assembly Resolution WHA67.20 “Regulatory system strengthening for medical products”

The 67th WHA approved the resolution “Regulatory system strengthening for medical products." It states the importance of regulations for medical devices as one of the medical products, for better public health outcome and to increase access to safe, effective and quality medical products. The complete text of the Resolution, in the 6 WHO official languages are available.

WHA67.20 resolution links

WHO activites concerning medical devices regulations

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

WHO published the WHO Global Model Regulatory Framework for Medical Devices including IVDs (the Model) to support its Member States in ensuring the quality and safety of medical devices.

Regulation of medical devices, A step-by-step guide

International Medical Devices Regulators Forum (IMDRF)

WHO is an official observer in the management committee of the “International Medical Devices Regulators Forum” (IMDRF).

Asian Harmonization Working Party (AHWP)

WHO also recognizes other regional organizations as “Asian Harmonization Working Party” (AHWP).

WHO will be developing training materials with professional organizations to assist national regulatory agencies with staffing of qualified biomedical engineers, technicians and regulatory professionals, to perform evaluation, registration, premarket approval and post-market surveillance activities for medical devices.

The 17th International Conference of Drug Regulatory Authorities

The 17th International Conference of Drug Regulatory Authorities (ICDRA) was held in Cape Town, South Africa, on 29 November–2 December 2016. The programme included sessions on medical devices, the recommendations are presented below:

ICDRA 2016
pdf, 257kb



Statistics

Regulatory systems for medical devices are less developed than those for other health products such as medicines or vaccines. According to desk survey performed in 2015-2016, 58% of WHO member states have a regulation for medical devices in place, no matter how limited. WHO has a clear role and mandate in building regulatory capacity through training and harmonization and is committed to this important work, with the support of all stakeholders.


Medical devices regulatory systems at country level

194 county profiles of regulatory status in WHO member states.