What are regulatory authorities?
Regulatory authorities (or regulatory bodies) are responsible for establishing regulations and oversight for manufacturing, importing, distributing, and using medical devices.
A National Regulatory Authority (NRA) is a government agency or organisation responsible for ensuring that products and services within its jurisdiction meet specific safety, efficacy, and quality standards. The roles and responsibilities of NRAs vary depending on each country’s capability, resources and priorities. Some of the key functions of regulatory authorities include:
- Establishing policies, laws, standards and guidelines for medical devices. These standards help ensure that devices are safe, effective, and high-quality.
- Regulatory authorities review and approve medical devices before being marketed and sold to users. This process is known as a conformity assessment and involves evaluating the product’s safety, effectiveness, and quality.
- Regulatory authorities police the medcial device market. Once a medical device is approved and placed on the market, regulatory authorities monitor it continuously. They monitor serious events through dedicated portals. Authorities are also responsible for conducting inspections and audits of medical device manufacturers, taking enforcement action when necessary. They can impose fines, restrictions, or other penalties for non-compliance with regulatory standards.
- Regulatory authorities provide manufacturers, healthcare professionals, and the public with guidance and education on regulatory requirements and best practices for using and managing medical devices.
Medical device regulatory authorities in major markets
- United States of America: Food and Drug Administration (FDA), FDA Medical Devices
- European Union: EMA Medical Devices regulated under the Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746.
- Australia: Therapeutic Goods Administration, TGA Medical Devices
- Canada: Health Canada, Health Canada Medical Devices
- Japan: Ministry of Health, Labour and Welfare (MHLW) administered by the Pharmaceuticals and Medical Devices Agency (PMDA).
- United Kingdom: Medicines and Healthcare Products Regulatory Agency MHRA Medical Devices
- South Korea: Ministry of Food and Drug Safety MFDS -China: National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration (CFDA).
- India: Central Drugs Standard Control Organization CDSCO
- Brazil: Agência Nacional de Vigilância Sanitária ANVISA
- South Africa: South Africa Health Products Regulatory Authority SAHPRA
This list is not exhaustive; additional regulatory bodies may exist at regional or local levels in different countries.
What is a stringent regulatory authority (SRA)?
A stringent regulatory authority (SRA) is a regulatory authority that enforces rigorous standards for approving and policing medical devices. Medical devices with SRA approvals are perceived as meeting high-quality standards. They are more likely to be accepted by other countries’ regulatory agencies as part of their own approval processes.
SRAs include:
- United States of America: Food and Drug Administration (FDA)
- European Union Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746.
- Australian Therapeutic Goods Administration
- Health Canada
- Japanese Pharmaceuticals and Medical Devices Agency (PMDA)
- World Health Organization (WHO) prequalification (WHO-PQ)
The International Medical Device Regulators Forum (IMDRF)
The International Medical Device Regulators Forum (IMDRF) is a global organisation focusing on regulatory harmonisation and convergence. Established in 2011, the IMDRF aims to promote international cooperation and convergence of regulatory practices. The IMDRF includes full members, affiliate members, and official observers, collaboratively developing guidance documents, and best practices that help streamline regulatory processes.
Current harmonisation initiatives include:
- APEC LSIF Regulatory Harmonization Steering Committee
- Global Harmonization Working Party (GHWP)
- Pan American Health Organization (PAHO)
- African Medical Devices Forum (AMDF)
Global harmonisation is an ongoing process, and it’s essential to recognise that each country retains its own medical device legislation and oversight mechanisms.