Resources
Get the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.
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
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.
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
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
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
Colombia INVIMA Medical Device Regulatory Approval Process
To market a medical device or IVD, manufacturers must register with the National Food and Drug Surveillance Institute (INVIMA), the country’s medical
Costa Rica medical device & IVD approval process
Medical device manufacturers who want to enter the Costa Rican market need to obtain approval from the Costa Rican Ministry of Health. There are a