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Table 5 Quotations of interviewees

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

Quotations

Stakeholder group

Area of regulation: Reporting culture of adverse events and complications during clinical practice

„Often they don’t know that there is a regulation for technovigilance.“

Macro level

„… we explained to the health professionals that finally they are the ones who complain about a product that fails and that the product does not provide the required results. However, me as authority how can I take notice about that < complaints > if they < end-users > dont make notifications, if they don't report failures than I cannot find it out and if I don't find it out I cannot react, if I dont react the things stay as they are.“

Macro level

„… not only the bad quality of the materials but also the bad service which they provide for technical assistance… This type of complaint converts into an internal report and stays there, I am sorry that I have to say that.“

Micro level

„… do you believe that the authorities of the institutions don't know the needs that exist?“

Macro level

Area of assessment: Decisions about the eligibility of HRMDs

„… we noticed the extremely poor culture of science that was present in the area of technology assessment.“

Macro level

„As a result of poor regulation every buys what he wants and we complain about lots of things…“

Meso level

„A lot of people said as well that we should skip the institutional standard lists.“

Macro level

Area of assessment: Decisions about the eligibility of HRMDs

„I believe that the first error of the pseudo transparency of implant procurement is that they buy at the lowest price.“

Macro level

“It's incredible that a surgery has to be cancelled because the supplier did not arrive with the material … Which economic penalty can compensate this damage to the patient…”

Micro level

“… a serious problem of the servicio integral is that they decide which brands they include in their service packages … Cheaper products so that they make more profit.”

Supplier

„… there are constant changes, when a new person comes sometimes he dosent has sufficient preparation to realize a tender.“

Micro level

„… the procurement agent knows the standard list but little about the basics of a joint implant.“

Supplier