Resources

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

China NMPA Medical Device Registration Requirements
Thinking of selling your medical device in China? If so, you need to register your device with China's regulatory authority, the China Food and Drug
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Learn about the Chinese CFDA regulations which apply to medical devices
China NMPA Medical Device Regulations
Shown below are some important regulatory documents impacting medical device companies. Unfortunately, the NMPA only makes these available in Chinese.
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CHINA – Overview of medical device industry and healthcare statistics
Below you will find basic demographic and healthcare market data on China, plus specific information about the medical device and healthcare
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Introduction to Colombia's Medical Device Approval Process
Colombia has over 48 million residents and is a very strong market for foreign medical device manufacturers. Interested in entering this market? This
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Download the free chart: Colombia Regulatory Approval Process for Medical Devices
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
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Learn about the Colombian INVIMA regulations which apply to medical devices
Colombia Medical Device Regulations
All Colombia medical device regulations listed below are in PDF format. Please help us maintain this list by reporting outdated or missing documents
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