The APACMed-ADVAMed position paper highlights the role of standards for harmonized regulatory processes to assure medical devices’ safety, quality and performance.
The standards should only focus on the necessary functional characteristics, not the design characteristics, to demonstrate compliance with Essential Principles. Accordingly, appropriate use of standards will promote efficiencies and innovation while facilitating objective assessment of device safety and performance.
The paper also underlines the cardinal role of the regulatory authorities to encourage, support and adopt international standards, and to endorse the use of the regulatory reliance model.
