• medical devices

National Regulatory Authorities discuss the challenges for the regulation of ventilators in the context of COVID-19

22 May 2020

Washington DC, 22 May 2020 (PAHO) —Representatives of the National Regulatory Authorities (NRA) from countries in the Region participated at the VI Regulatory Update meeting organized by the Pan American Health Organization (PAHO) to discuss the challenges for the regulation of ventilators in the context of COVID-19. More than 80 participants from 21 countries of the Region joined the virtual meeting which took place on 21 May 2020.

"The countries of the Americas are working hard on the reorganization of health services, searching for safe and effective health technologies to face the COVID-19 pandemic, including ventilators," said James Fitzgerald, Director of the PAHO Department of Health Systems and Services. "This meeting aims to exchange experiences and share the challenges that countries face in their regulatory frameworks for the use of ventilators in response to the demand of health systems to address the pandemic."

Alexandre Lemgruber, Regional Advisor for Health Technology Management at PAHO, listed the lines of work on ventilators, that are: regulation, clinical management, technology management, and innovative initiatives and production. Lemgruber also discussed the recently published document on "Regulation of Medical Devices in the context of COVID-19", that presents a search for information related to marketing authorization requirements, manufacturing, technical specifications, and recommendations for use of ventilators, personal protective equipment (PPE), and 3D printing products.

In addition, updates to the List of Priority Medical Devices in the context of COVID-19 were presented, which include, among others, technical specifications of devices for non-invasive ventilation (high-flow nasal cannula - HFNC, BiPAP device – bilevel positive airway pressure system and CPAP device - continuous positive airway pressure). 

Representatives of the National Regulatory Authorities from Argentina (Marcela Rizzo, Director of the National Institute of Medical Products, ANMAT), Brazil (Anderson Pereira, Manager of Technologies and Equipment, ANVISA), Colombia (Lucia Ayala, Technical Director of Medical Devices and Others Technologies, INVIMA) and the United States (Ana Patricia Pineda, International Regulatory Analyst, Office for Latin America, Food and Drug Administration) presented on the experiences and regulatory challenges for the incorporation of ventilators in the health systems of their countries.

Some of the key issues discussed include:

  • Flexibility of regulatory requirements for ventilator manufacturers in the context of COVID-19 to obtain an emergency use authorization.
  • Requirements for registration, manufacturing, marketing, import, and donation.
  • Innovative projects being developed in the Region to face the pandemic (low-cost ventilators prototypes, adaptation of medical devices) and its challenges (manufacturing, technical specifications, efficacy, safety, among others).

PAHO’s extensive response to the pandemic has centered on supporting countries with technical guidelines, training, supplies, and information. The virtual meeting was the sixth meeting held by PAHO to discuss updates on the regulatory response, and to address countries´ challenges and concerns.