Medical devices regulations
Regulation is primarily concerned with enabling patient access to high quality, safe and effective medical devices, and restricting access to those products that are unsafe or have limited clinical use. When appropriately implemented, regulation ensures public health benefit and the safety of patients, health care workers and the community. Thus, assisting member states through regulatory guidance, training, coordination and promotion of international best practices is a priority for the Diagnostic Imaging and Medical Devices (DIM) team.
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”. Furthermore, WHO’s Strategic Objective 11 states that it is necessary for WHO: “to ensure improved access, quality and use of medical products and technologies”.
67th World Health Assembly Resolution WHA67.20 “Regulatory system strengthening for medical products”
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 the 6 WHO official languages are available.
WHA67.20 resolution links
Some important notes in the WHA67.20 resolution 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.
WHO activites concerning medical devices regulations
WHO promotes and recognizes the guidance provided by the 5 study groups of the “Global Harmonization Task Force” (GHTF) during the last 20 years.
WHO is an official observer in the management committee of the “International Medical Devices Regulatory Forum” (IMDRF).
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.
2016 WHO Global Model Regulatory Framework for medical devices including IVDs
WHO initiated the development of 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. Based on Resolution WHA 67.20 ‘Regulatory Systems Strengthening for Medical Products’ adopted by the World Health Assembly in 2014, WHO has undertaken a series of activities to scale up and strengthen regulatory capacities worldwide.
Model regulatory framework
- Regulation of medical devices, A step-by-step guide, developed by the WHO Eastern Mediterranean Regional Office
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
Regulatory systems for medical devices are less developed than those for other health products such as medicines or vaccines. According to the 2013 WHO Baseline Country Survey on Medical Devices, only 69% of 175 responding countries have a national authority responsible for implementing and enforcing medical device regulations. Many of those governments that have drafted regulations have made little progress in implementing them. 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 regulation in regions
In order to provide information about the regulatory process of medical devices in Member States, please see table below to a list of medical devices regulatory authorities, with links to their websites, legislation, safety alerts, database of adverse events, if available and contact information.
- Africa Region - Laboratories and Health Technology
- Region of Americas - Medicines and Health Technologies
- European Region - Health Technologies and Medicines
- Eastern Mediterranean Region - Medical Devices
- South-East Asia Region - Health Technology and Patient Safety Topics
- Western Pacific Region - Health technology and laboratory