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jlw23 replied to the topic Design Controls in the other countries in the forum Introduction to Design Controls 7 years, 5 months ago
There are design controls in most countries that design and manufacture medical devices. There are all specific to their particular country and must follow the standards given by that particular country. However, that are many med-devices that can be found in different country’s under the same company name. There are medical device regulation consulting groups that would service specific countries insuring that the design controls are upheld with the particular standards of that country.
The company Emergo group is one of these companies (https://www.emergogroup.com/). There are standards that they follow as well that apply on a global scale.
http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf.