Medical Devices
Medical devices are regarded as a basic part of health systems; the advantages they can offer keep growing since they’re necessary for the safe and effective prevention, diagnosis, treatment, and rehabilitation of illnesses and diseases.
Medical device manufacture, regulation, planning, assessment, acquisition, and management are intricate processes, but they are necessary to ensure the products’ high quality, safety, and suitability for the environments in which they are used.
Medical Device Facts
- In particular, medical devices are essential for patient rehabilitation, disease prevention, diagnosis, and treatment.
- “Any intervention that may be used to promote health, to prevent, diagnose, or treat disease, or for rehabilitation or long-term care” is what is referred to as health technology.
- Developing and rising nations may contextualise global information, facilitate transparent and responsible decision-making, and advance health equity with the use of appropriate HTA initiatives.
Medical devices are regarded as a basic part of health systems; the advantages they can offer keep growing since they're necessary for the safe and effective prevention, diagnosis, treatment, and rehabilitation of illnesses and diseases. Medical device manufacture, regulation, planning, assessment, acquisition, and management are intricate processes, but they are necessary to ensure the products' high quality, safety, and suitability for the environments in which they are used.
Regulation
There are now more than 10,000 distinct types of medical devices in use worldwide as a result of the medical device market’s rapid expansion and technological advancements in healthcare. The countries of the Americas region represent a significant market for medical devices; in fact, this industry has seen high annual growth rates in a number of these nations. The nations import more than 80% of their medical equipment, with very few exceptions. The top goal for nations continues to be patient safety and access to high-quality, safe, and effective medical devices.
Health authorities have a dizzying array of alternatives when it comes to new, technologically advanced, and increasingly sophisticated medical gadgets. In addition to having more options, authorities must also take into account the technological complexity of the devices, more global and competitive markets, an increase in the marketing of used and refurbished equipment, donations of devices, reuse of single-use devices, an increase in the use of devices in doctor’s offices and households, patients with greater access to information, inadequate post-sale technical support services, and the need to set up a post-marketing surveillance system.
It is essential to provide access to high-quality, safe, and effective medical devices and to restrict those products that are harmful or have restricted clinical application through regulatory processes in order to secure the benefit of public health and the safety of patients, healthcare professionals, and the community.
The Member States were asked to improve their programs for the regulation of medical devices by the 42nd Directing Council’s resolution CD42.R10 on medical devices. Later, the World Health Assembly resolution WHA60.29 urged Member States to strengthen their national regulatory systems, participate in global, regional, and subregional networks of national regulatory authorities, and promote international cooperation as necessary. It also requested the General Director to give priority support to the establishment and strengthening of regional and subregional networks of regulatory authorities, as necessary, including strengthening areas of national priority. The World Health Assembly recently approved a resolution, known as WHA60.27, that aims to improve the regulatory framework for medical products.
