Resources
Get the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.
Get smart about Australia in 1 hour
If you are thinking about entering the Australian market for the first time, understanding the Therapeutic Goods Association (TGA) regulatory
TGA - Australia Therapeutic Goods Administration
The Therapeutic Goods Administration is the Australian regulatory authority for therapeutic goods such as pharmaceuticals, blood products and tissues
AUSTRALIA – Overview of medical device industry and healthcare stats
Below you will find basic demographic and healthcare market data on Australia, plus specific information about the medical device and healthcare
Get smart about Brazil in 1 hour
If you are thinking about entering the Brazilian market for the first time, understanding ANVISA’s regulatory requirements can be overwhelming.
BRAZIL – Overview of medical device industry and healthcare statistics
Below you will find basic demographic and healthcare market data on Brazil, plus specific information about the medical device and healthcare
ANVISA - Brazil National Health Surveillance Agency
The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency that is responsible
Health Canada: Structure and Overview
Health Canada is a federal department responsible for the national public health of Canadians. It regulates the use of consumer goods, drugs,
Get smart about Canada in 1 hour
If you are thinking about entering the Canadian market for the first time, understanding Health Canada’s regulatory requirements can be overwhelming
List of Registrars Recognized by Health Canada
The following Registrars are authorized by Health Canada to issue quality management system certificates for: CAN /CSA ISO 13485:2003 ISO 13485:2003