Medical Devices

Foto: Ary Rogerio Silva, OPS/OMS

Medical Devices are considered a fundamental component of Health Systems; the benefits they can provide continue to increase as they're essential to prevent, diagnose, treat and rehabilitate illnesses and diseases in a safe and effective way.

The steps that involve Medical Devices manufacturing, regulation, planning, assessment, acquisition, and management are complex but essential to guarantee their quality, safety and compatibility with the settings in which they are used.

Key facts

Medical devices, in particular, are crucial in the prevention, diagnosis, and treatment of illness and disease, as well as patient rehabilitation
A health technology is “any intervention that may be used to promote health, to prevent, diagnose or treat disease or for rehabilitation or long-term care”
Appropriate HTA strategies enable developing and emerging countries to contextualize global knowledge, support transparent and accountable decisionmaking, and promote health equity.

��鶹��Ʒ Response

The ��鶹��Ʒ (��鶹��Ʒ), through the Medicines and Health Technologies area, supports countries of the Americas Region with Medical Device Regulation, Health Technology Management and Health Technology Assessment (HTA).

��鶹��Ʒ undertakes several activities in order to build capacity in Member States through Regional meetings and workshops, technical cooperation, information sharing, and training through online courses.

The objective of ��鶹��Ʒ is to collaborate with the Member States in the creation and strengthening of Regulatory Capacity on Medical Devices in the Americas Region in order to guarantee the quality, safety and efficacy of products used by the population.

��鶹��Ʒ has promoted the harmonization of the regulatory requirements of several countries through annual Regional meetings, information exchange, joint projects, training and the recent designation of CECMED as a ��鶹��Ʒ/WHO Collaborating Centre for the Regulation of Health Technologies.

In 2014, ��鶹��Ʒ was designated as an Affiliate Organization of the

List of priority medical devices for the first level of care

Medical Devices are considered a fundamental component of Health Systems; the benefits they can provide continue to increase as they're essential to prevent, diagnose, treat and rehabilitate illnesses and diseases in a safe and effective way. The steps that involve Medical Devices manufacturing, regulation, planning, assessment, acquisition, and management are complex but essential to guarantee their quality, safety, and compatibility with the settings in which they are used.

The Medical Device market has grown fast; following technological trends in healthcare to improve people's welfare, there are currently more than 10, 000 different kinds of medical devices around the world. The countries of the Americas Region are an important market for medical devices; indeed, in several countries this sector has witnessed a rapid annual growth rate. With few exceptions, the countries import more than 80% of their medical devices. Nevertheless, patient safety and access to high quality, safe and effective medical devices remains the top priority for countries.

Health Authorities face an overwhelming variety of options with regard to increasingly sophisticated, technologically complex and new medical devices. In addition to having more options, authorities must also consider the technological complexity of the devices; more global and competitive markets; increases in the marketing of used and refurbished equipment; donation of devices; reuse of single-use devices; ever-increasing use of devices in physician's offices and at the household level; patients with greater access to information; weak post-sale technical support services; need to establish a post-marketing surveillance program as well as the challenge of delivering good quality services and beneficial treatments as a function of cost-effective Medical Devices.

To ensure public health benefit and the safety of patients, healthcare workers and the community, it is necessary to guarantee access to high quality, safe and effective medical devices and to restrict those products that are unsafe or have limited clinical use through regulatory processes.

The resolution CD42.R10 on Medical Devices, approved during the 42nd Directing Council, urged the Member States to develop and strengthen their programs for the regulation of Medical Devices. Later, the World Health Assembly resolution WHA60.29 urged the 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 also requested the General Director 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 and to support the building-up of effective national and regional regulatory bodies and networks. More recently, the World Health Assembly approved the resolution WHA60.27 on Regulatory system strengthening for medical products.

In 2012, ��鶹��Ʒ held the "1st Regional Meeting of the Regulatory Authorities for the Strengthening of Regulatory Capacity on Medical Devices in the Americas Region" in La Habana, Cuba; it was joined by representatives of the National Regulatory Authorities (NRAs) of several Member States. During the meeting, a Regional Working Group was established and is currently comprised of 16 NRAs; countries join the Working Group voluntarily, with the commitment to work in solidarity to advance towards achieving the set objectives.

The Regional Working Group on Medical Device Regulation aims to strengthen the Regulatory Capacity on Medical Devices through Regional exchange of information in PRAIS, joint projects and training strategies towards the harmonization of regulatory requirements.

PRAIS

The Regional Platform on Access and Innovation for Health Technologies is composed of a series of virtual tools designed to support and promote technological innovation, access, rational use, regulation and governance of health technologies from a public health perspective. ��鶹��Ʒ expects the platform to facilitate the development of linkages between stakeholders for innovation in health systems that extend beyond institutional, country and sector boundaries.

The Community of Practice on Regulation of Medical Devices (CoP) is an instrument that enables exchange of knowledge and information related to Regulation among members. The CoP allows members to share reports, documents, and presentations, and also have information about events, meetings, and workshops promoted by the Medicines and Health Technologies Unit. Moreover, the Community has a discussion group where members discuss about a relevant topics related to Medical Device Regulation.

Initiatives

��鶹��Ʒ — United States Agency for International Development (USAID) — Interaction between HTA and Medical Devices Regulation

In 2013, the ��鶹��Ʒ-USAID funded the project about the interaction between Medical Devices Regulation, Health Technology Assessment, and the Incorporation of technologies in the health systems in the American region. The project was comprised of four country case studies which cite an example of a technology that has been adopted into the health care system, while explaining the different interactions between all institutions and processes involved. These case studies focused on medical devices in Argentina, Colombia, Mexico, and Uruguay.

Each case study comprised three components:

A description and analysis of the process of medical device registration, including HTA and incorporation in each country.
A case study of an adopted medical device into the health care system with examples on the different interactions between regulatory agencies and institutions.
A final report including findings and recommendations on how to better integrate decision-making with regulatory processes and the interactions between agencies and institutions.

Regional meetings

X Meeting of Regulatory Authorities for the Strengthening of the Regulatory Capacity of Medical Devices in the Americas

The ��鶹��Ʒ (��鶹��Ʒ) organized the X Meeting of Regulatory Authorities for the Strengthening of the Regulatory Capacity of Medical Devices in the Americas, from June 1 to 3 2022, in the context of the activities of the Regional Working Group on Medical Device Regulation.

During 1-2 June, the open session took place with 255 participants from 19 countries, including regulators, industry representatives, and other interested parties. ��鶹��Ʒ discussed included an update of the activities of the Regional Working Group, Good Regulatory Practices for Medical Devices, and reliance in the Authorization for Emergency Use of Medical devices. On the afternoon of 2 June and the morning of 3 June, the closed session took place with the attendance of 116 participants from 14 countries in the Region. Among the attendees were directors, unit chiefs, reviewers, department managers and professionals specialized in medical devices from the NRAs of Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cuba, El Salvador, United States of America, Guatemala, Honduras, Mexico, and Uruguay.

The agenda included updates on topics related to the regulation of medical devices, including the different activities of the Regional Working Group, the World Health Organization, and the International Medical Device Regulators Forum (IMDRF).

Additionally, the first roundtable on the regulation of assistive products in the Region was held, during which the NRAs of Brazil, Argentina, Cuba, and Colombia exchanged their experience in regulating these products for people living with functional difficulties.

1st June 2022

Recordings

Spanish
English
Portuguese

Presentations

Update on the activities of the Regional Working Group on Medical Devices Regulation, Alexandre Lemgruber, ��鶹��Ʒ

20220601-ops-oms.pdf6.93 MB
Good Reliance Practices in Emergency Use Authorizations for Medical Devices. NRA Experiences. Marie Valentin, WHO

20220601-oms.pdf2.62 MB

The Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector and its work in support of advances in the Region. Sandra Ligia González, IACRC

20220601-iacrc.pdf3.4 MB

2nd June 2022

Recordings

Spanish
English
Portuguese

Presentations

Good Reliance Practices in Emergency Use Authorizations for Medical Devices. NRA Experiences

Reliance for the Authorization for Emergency Use of Medicines and Other Health Technologies in a Pandemic (e.g. COVID 19). Alexander Lemgruber, ��鶹��Ʒ

20220602-ops.pdf3.29 MB
Argentina – ANMAT. Marcelo Velasques, ANMAT

20220602-anmmat.pdf807.1 KB
Cuba – CECMED. Mario Muñiz, CECMED

20220602-cecmed.pdf3.3 MB
Colombia – INVIMA. Lucía Ayala, INVIMA

20220602-invima.pdf3.46 MB
El Salvador, DNM. Mario Vega, DNM

20220602-dbn.pdf1.77 MB
United States of America – FDA. Vesa Vuniqi, FDA
Mexico – COFEPRIS. Edgardo Arenas, COFEPRIS

20220602-cofepris.pdf1.96 MB

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Management of Medical Equipment

The successful delivery of health care depends largely upon medical devices; therefore, the Management of Medical Equipment (MME) is one of the most important areas within Health Systems. This area requires the active participation of staff from different disciplines such as: technical, clinical, financial, administrative, among others.

In developed countries, the MME includes designating a unit of professionals trained in the proper handling and management of medical equipment. MME promotes a better use of technology, and greater efficiency and effectiveness in hospitals. The MME issue has yet to gain momentum in Latin America; because of the lack of trained personnel, equipment is underutilized, broken, or abandoned.

��鶹��Ʒ's role in Management of Medical Equipment

��鶹��Ʒ, through the Medicines and Health Technologies Unit, promotes and facilitates the adoption of proper Management of Medical Equipment in the Americas Region through technical assistance, online training, regional cooperation, dissemination of documents, among others and the designation of as a ��鶹��Ʒ/WHO Collaborating Centre in Health Technology; also recognizes the significant impact of the Units of Biomedical / Clinical Engineering in the quality of health care services and therefore promotes its incorporation into the local health care.

��鶹��Ʒ/WHO Collaborating Centres in Medical Devices

��鶹��Ʒ/WHO Collaborating Centre for the Regulation of Health Technologies

Country: Cuba

Date of designation: 14/Jul/2014

Terms of Reference:

Assisting ��鶹��Ʒ/WHO in the strengthening of the Health Authorities Network for the regulation of medical devices, ensuring effective and timely exchange of regulatory information between countries in the region.
In collaboration with ��鶹��Ʒ/WHO, to improve the capacity in the region on regulation of medical devices.
Assisting ��鶹��Ʒ/WHO in the development and dissemination of documents regarding medical devices regulatory issues
To provide technical assistance in assuring the quality, safety and efficacy of medical devices at the global, regional and national levels.
To participate in collaborative studies and to conduct regulatory research according to WHO priorities.

Learn about the Regional Base of Health Technology Assessment Reports in the Americas - BRISA (in Spanish)