Regulators determine the extent and complexity of regulatory oversight across each stage of the medical device life cycle. A clear and coordinated system of regulatory controls, together with manufacturers’ robust quality systems, ensure that medical devices are safe, and perform as intended. The implementation of harmonized regulatory controls across jurisdictions enables cross-border leveraging of regulatory resources and reduce the burden on this highly regulated sector. More importantly, it ultimately ensures a better access to lifesaving medical products for patients.

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