Resources
Canada
Medical Devices Main Page
With links to application information, legislation, guidance documents, licence databases, standards, fees, and more.
Medical Devices Regulation SOR/98-282
Governing regulation for medical devices in Canada. Includes medical device classification rules in Schedule 1.
Understanding How Medical Devices are Regulated in Canada
An e-learning tool to educate stakeholders on the pre-market regulatory requirements for medical devices in Canada.
Personal Information Protection and Electronic Documents Act (PIPEDA)
The federal privacy law for private-sector organizations in Canada. It sets the requirements for how businesses must handle personal information, including health information, in the course of their commercial activity. Note that several Canadian provinces also have health information privacy laws which apply to personal health information and supersede PIPEDA within their respective provinces. More details can be found here.
USA
Device Advice
Comprehensive regulatory assistance, explaining U.S. medical device laws, regulations, guidance’s, and policies, across the entire product lifecycle.
FDA Guidance Documents
Prepared for the public by the FDA to describe the FDA’s interpretation of a regulatory issue.
CDRH Learn
Learning modules that cover medical device regulations, guidance, and policies in video, audio, and slide presentation formats.
Health Information Portability and Accountability Act (HIPAA)
A federal law that required the creation of national standards to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge. Subsequently, the U.S. Department of Health and Human Services (HHS) issued the HIPAA Privacy Rule and HIPAA Security Rule to set out the governing requirements.
European Union
Medical Device Regulation (MDR) 2017/745
Official regulation for medical devices marketed in all EU member countries.
In Vitro Diagnostic Regulation (IVDR)
Regulation governing in vitro diagnostic devices in all EU member countries.
Medical Device Coordination Group (MCDG)
The MDCG is an expert group representing competent authorities of the EU countries. Guidance Documents are developed by the MDCG to present a common understanding of how the MDR and IVDR should be applied in practice.
MDLaw.eu
Additional guidance on MDR Compliance.
General Data Protection Regulation (GDPR)
The EU privacy and security law which imposes obligations on organizations everywhere if they collect data related to people in the EU.
UK
Medicines and Healthcare Products Regulatory Agency (MHRA)
UK’s medical device regulator.
Regulatory guidance
Various guidance documents to assist stakeholders in interpreting UK medical device regulations.
UK Medical Devices Regulation 2002
Current governing legislation for medical devices in the UK.
Other Countries
Therapeutic Goods Administration (TGA)
Australia’s medical device regulator.
Angencia Nacional de Vigilancia Sanitaria (ANVISA)
Brazil’s medical device regulator.
Pharmaceuticals and Medical Devices Agency (PMDA)
Japan’s medical device regulator.
General
Medical Device Single Audit Program (MDSAP)
Allows a single audit recognized by multiple regulatory agencies in place of their routine inspections. Currently recognized by the USA, Canada, Brazil, Australia, and Japan.
International Medical Device Regulators Forum (IMDRF)
The IMDRF is a voluntary group of medical device regulators from around the world that aims to accelerate international medical device regulatory harmonization and convergence.