Skip to main content

Table 1 Principle actors involved in MDLC areas

From: The regulation, assessment, and management of medical devices in Mexico: How do they shape the quality of delivered healthcare?

Stakeholders

Main responsibility

Relative importance for MDLC areas

  

Tehno-vigilance

Assessment

Purchasing

Sub-secretariat for Health System Integration and Development, SIDSS

• Government agency whose mission is to propose to the MoH national policies that improve the quality of social health services; issues the Mexican Official Norms (NOM)

++

+++

++(+)

Departments of Sub-secretariat for Health System Integration and Development

• General directorate of health planning and development, DGPD: Governmental organization and unit under the authority of the SIDSS whose mission is to steer the strengthening of health services among policy makers, and giving guidance to improve health services sustainable and cultural based on populations’ needs.

• General directorate of quality and education, DGCE: Governmental organization and unit under the authority of the SIDSS whose mission is to ensure that the quality and safety of health services, including human resources of the health sector and the regulatory environment of social health supplies is aligned with national policies.

++

+++

++(+)

General Council of Health, CSG

• Sanitary authority directly accountable to the President

• Council whose mission it is to strengthen the governance and the articulation of the National System of Health. Founded: 1917

• Publishes the standard list of Health Supplies

• Holds the Inter-institutional Commission of the standard list for Health Supplies whose mission is to manage the approved technologies in the standard list for Health Supplies

• Auditing of hospitals with regards to quality standards (certification process)

++

++(+)

+

Federal Commission for the Protection against Sanitary Risks, COFEPRIS

• Decentralized organ of the MoH whose mission is to protect the population against medical risks derived from the introduction of new medical drugs, medical devices and other health inputs. Founded: 2002

• Sanitary Authorization Commission whose mission is the market approval of medical products and technologies.

• Technovigilance department whose mission is to implement and realize post-market surveillance.

• Support function of “Sanitary Authorization Commission” whose mission is to provide technovigilance reports for the renovation of market approval.

+++

++

+

National Centre for Health Technology Excellence, CENETEC

• Governmental organization and unit under the scope of the SIDSS whose mission is to contribute to the development and governance of the National Health System in Mexico based on: Health Technology Assessments, Supervision of medical equipment, Telemedicine, Clinical guidelines. Founded: 2004

• WHO collaborating centre.

++

++(+)

++(+)

Sub-systems: Centralized and decentralized health services

• Functionary with national responsibilities within the sub-system; director of healthcare facility; procurement agent

+++

++(+)

+++

 

• Functionary with local responsibility: Head of orthopaedic department

-

+(+)

++

  1. +++ strong relation ++ moderate relation + low relation - no relation