Resources

Get the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.

Transitioning to Medical Device Single Audit Program (MDSAP) Compliance
As the first year of its operational phase ends, the Medical Device Single Audit Program (MDSAP) is finally gaining traction among medical device
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Learn about Health Canada
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
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Learn about basic demographic and healthcare market data on Canada
CANADA – Overview of medical device industry and healthcare statistics
Below you will find basic demographic and healthcare market data on Canada, plus specific information about the medical device and healthcare
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Learn about the Health Canada regulations which apply to medical devices
Health Canada Medical Device Regulations
We have assembled the following documents about Medical Device Regulations from Health Canada as a service to the medical device community.
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NMPA - National Medical Products Administration
The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug
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Medical device registration process in China
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
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Get smart about China in 1 hour
If you are thinking about entering the Chinese market for the first time, trying to understand the CFDA regulatory requirements can be overwhelming.
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China Medical Device Market Overview
With over 1.3 billion residents, China has one of the world's largest medical device markets. Medical device manufacturers around the world are
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