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 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”.
WHO promotes and recognizes the guidance provided by the 5 study groups of the “Global Harmonization Task Force” (GHTF) during the last 20 years. GHTF will have their last meeting in November 2012 in Japan and will be soon setting.
WHO is now is looking forward to the recently created “International Medical Devices Regulatory Forum”, (IMDRF) where WHO is an official observer. 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.
WHO provides guidance on the topic of medical devices regulations and will soon be producing reference documents on premarket approval and post-market surveillance.
Regulatory systems for medical devices are less developed than those for other health products such as medicines or vaccines. According to the 2010 WHO Baseline Country Survey on Medical Devices, only 65% of 145 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.
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.