Standards Alliance Phase II

Medical Devices

and COVID-19 Projects

The Standards Alliance's medical devices and COVID-19 relief projects promote regulatory convergence in the context of COVID-19, good regulatory practice (GRP), and the adherence and adoption of medical device international standards.

Active Regions: Latin America, Indo-Pacific, and Africa

Project: COVID-19 Medical Device Regulatory Convergence Project (MDRC)
Implementer: Advanced Medical Technology Association (AdvaMed)

The Challenge:

Amidst the COVID-19 pandemic, nations have scrambled to increase production and access to medical devices to prevent and treat the virus, such as rapid diagnostic test kits, ventilators, and personal protective equipment (PPE). However, countries cannot safely deploy these products without a strong medical device regulatory framework and knowledge of emergency use authorization (EUA) procedures and rules.

Medical device regulatory agencies that forgo relying on the regulations and standards of the global community must use their limited public health resources to develop agency and country-unique technical regulations. The Advanced Medical Technology Association (AdvaMed) estimates that the lack of global medical device regulatory convergence costs public health systems and the medical technology industry $4 billion per year, the majority of which occurs in developing countries.

Our Work:

This project increases the transparency and predictability of partner governments’ regulatory ecosystems for medical devices, aligning them with international standards, and improving their overall National Quality Infrastructure. The MDRC project will:

  • build capacity of partner countries for standards and conformity assessment procedures related to medical devices;
  • remove countries’ technical barriers to trade for medical devices;
  • increase patients’ access to needed high-quality PPE and other medical technologies to respond to and recover from COVID-19 and future global health crises; and,
  • foster private sector engagement in the medical technology regulatory space.
Where we work:

Countries: Colombia, Mexico, Peru, Brazil, Vietnam, Indonesia, South Africa, Kenya, Ghana

Regions: Latin America, Indo-Pacific, and Africa

Additional Resources:

Project: COVID-19: Surgical Mask Production Project
Implementer: Ethical Apparel Africa (EAA)

The Challenge:

In Ghana, COVID-19 has highlighted the need for more manufacturers of personal protective equipment (PPE) and the country’s reliance on foreign imports. It has also shown that much of the PPE on the marketplace is not fully certified or reaches ASTM quality standards. Ghana has an opportunity to pivot manufacturing production to PPE and stand out as a certified, quality supplier of PPE. Pivoting to this highly technical product requires significant investment both in machinery and skill development and know-how.

Our Work:

Developing Ghana as a hub for PPE production requires knowledge transfer and increased understanding of ASTM standards both at the government level and in other agencies such as the Ghana FDA and the Ghana Standards Authority. This project will:

  • Manage the PPE certification, accreditation and testing process to ensure right first time passing and no product failure;
  • Establish with the Ghana FDA the standards and related packaging required for the product;
  • Deliver Specialist training programs for Ghana Ministry of Health, Ghana Ministry of Trade and Industry, Ghana FDA and GSA on quality requirements and procuring PPE; and
  • Train the sales & operating team at EAA and Maagrace Garment Industries Ltd. to follow SOP’s and ensure continued standard adherence.
Where we work:

Ghana

Additional Resources:
  • Learn more about EAA
  • about this project
View all SA2 Projects