medical devices 1The 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.

The objective of PAHO 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. PAHO 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 PAHO/WHO Collaborating Centre for the Regulation of Health Technologies.

In 2014, PAHO was designated as an Affiliate Organization of the International Medical Devices Regulators Forum (IMDRF).

Regional Working Group on Medical Device Regulation

In 2012, PAHO 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. PAHO 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

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

In 2013, the PAHO-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 Working Group on Medical Device Regulation Table

Country NRA WEB SITE
Argentina Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) www.anmat.gov.ar
Brazil Agência Nacional de Vigilância Sanitária (ANVISA) portal.anvisa.gov.br
Canada Health Canada
www.hc-sc.gc.ca/index-eng.php
Chile Agencia Nacional de Medicamentos (ANAMED
www.ispch.cl/anamed_
Costa Rica
Ministerio de Salud de Costa Rica
www.ministeriodesalud.go.cr
Colombia Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
www.invima.gov.co
Cuba Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)
www.cecmed.cu
Ecuador
Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA)
www.controlsanitario.gob.ec
El Salvador Dirección Nacional de Medicamentos
www.medicamentos.gob.sv
Honduras Dirección General de Regulación Sanitaria
www.dgrs.gob.hn
Mexico
Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
www.cofepris.gob.mx
Panama Ministerio de Salud de la República de Panamá
www.minsa.gob.pa
Paraguay Dirección Nacional de Vigilancia Sanitaria (DINAVISA)
www.mspbs.gov.py/dinavisa
Peru
Dirección General de Medicamentos, Insumos y Drogas (DIGEMID)
www.digemid.minsa.gob.pe
Dominican Republic Ministerio de Salud Pública
www.sespas.gov.do
Uruguay Ministerio de Salud Pública - República Oriental de Uruguay
www.msp.gub.uy