Resources

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

Learn about the Indian regulations which apply to medical devices
India Medical Device Regulations
The document was published by the Ministry of Health and Family Welfare (MHFW) and is in PDF format.
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Learn about the Japanese PMDA regulations which apply to medical devices
Japan Medical Device Regulations
The following documents were published by Japan's Ministry of Health, Labour and Welfare (MHLW) or the Pharmaceutical and Medical Devices Agency (
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Learn about the Malaysian regulations which apply to medical devices
Malaysia Medical Device Regulations
All were published by the Medical Device Control Division, Ministry of Health Malaysia (MDCD) and are in PDF format.
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Learn about the Mexican COFEPRIS regulations which apply to medical devices
Mexico Medical Device Regulations
We have assembled the following documents as a service to the medical device community. Documents are in PDF format.
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Learn about the New Zealand regulations which apply to medical devices
New Zealand Medical Device Regulations
All documents listed below were published by the New Zealand Ministry of Health Medicines and Medical Device Safety Authority (MedSafe) and are in
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Learn about the Peruvian regulations which apply to medical devices
Peru Medical Device Regulations
Medical Device Regulations in Peru
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Learn about the Russian regulations which apply to medical devices
Russia Medical Device Regulations
The following documents were published by the Russian agency Roszdravnadzor and are in PDF format.
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Learn about the Saudi Arabian regulations which apply to medical devices
Saudi Arabia Medical Device Regulations
Downloadable files of Medical Device Regulations published by the Saudi Food & Drug Authority (SFDA).
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Learn about the regulations from Singapore which apply to medical devices
Singapore Medical Device Regulations
All documents were published by the Health Sciences Authority (HSA) in Singapore and are in PDF format.
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