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Preparing a Canadian MDL Application
So you have one or more cleared medical devices in the US and now you want to license them in Canada. While the Canadian registration system seems
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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
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ISO 13485:2016: Six Key Differences for Medical Device Companies
The publication of ISO 13485:2016 introduced significant changes for device manufacturers around the world. Some changes are specific, while others
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Medical device QMS compliance in Canada
Achieving QMS compliance in Canada for medical device and IVD companies
This white paper will discuss the requirements for achieving compliance with the Quality Management System (QMS) regulations as they apply in Canada
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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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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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