Support to the Public Health Institute (ISP) to strengthen the regulation of medical devices in Chile
Constant innovations make new medical devices appear on the market every day. There are currently more than 2 million different medical devices in the world that cover very different products, from a simple syringe to an innovative robotic surgical equipment. It is an even broader universe than that of medicines and is one of the causes of the increase in health spending.
Before this technical cooperation, only five medical devices were regulated in Chile. This implied latent risks to guaranteeing safety and access to all medical devices present in the market. The creation of the Department of Medical Devices within the ISP and the intention of promulgating a new norm for the registration of devices that are marketed in the country generated a window of opportunity to strengthen the regulation of medical devices.
What did our support consist of?
A diagnosis was made of the state of the institutional, normative and technical processes that comprise the regulation of medical devices in Chile. Based on the need to identify the manufacturers, importers, and distributors of medical devices, as well as the products offered in the Chilean market, a Master Implementation Plan was proposed that established 5 priority processes:
- Registration and definition of regulatory routes according to the type of risk.
- Strengthening the current surveillance process at the point of entry.
- Technovigilance to report adverse events and send mandatory notifications, and the application of procedures to recall unsafe medical devices from the market.
- Oversight with gradual requirements and prioritized field audits.
- Prioritization of radiological health, according to ministerial provisions in this area.
- Patricia Jara – Team leader
- Stephanie Puerto – Coordinator
- Úrsula Giedion – Technical adviser
Consultants and collaborators
- Aurelio Mejía – Technical leader Phase I
- Natalia Jorgensen – Technical leader Phase II
- Josée Hansen – International expert in medical devices
- Rodrigo Muñoz – Costing expert
- Manuel Espinoza – Local expert
The project had the valuable support of the National Institute of Drug and Food Surveillance (INVIMA), of Colombia, and the National Administration of Drugs, Food and Medical Technology (ANMAT), of Argentina.