Resources
Get the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.
Australia TGA Regulatory Approval Process for Medical Devices
The chart shown illustrates the TGA approval process in Australia and is available for download in PDF format. Also includes a timeline of expected
Brazil ANVISA Regulatory Approval Process for Medical Devices
Medical device manufacturers need to obtain ANVISA (Agência Nacional de Vigilância Sanitária) approval prior to selling their products in Brazil.
Brazil ANVISA Regulatory Approval Process for IVDs
Manufacturers need to obtain ANVISA ( Agência Nacional de Vigilância Sanitária ) approval prior to selling their products in Brazil. Brazil has four
Health Canada Regulatory Approval Process for Medical Devices
To obtain access to the Canadian market, medical device manufacturers will need to secure a license. Health Canada issues two types of licenses: the
Health Canada Regulatory Approval Process for IVDs
The chart shown illustrates the Health Canada approval process for In Vitro Devices (IVDs) and is available for download in PDF format. However, if
China NMPA Regulatory Approval Process for Medical Devices
To see their products to the Chinese market, medical device and IVD manufacturers will need to obtain National Medical Products Administration (NMPA