WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 5.1-law: Government: give device regulation a sound legal basis that defines products and regulated parties, requires only safe, performing, quality devices on the market, empowers and holds the NRA accountable, and coordinates with justice, police and customs

What does 5.1-law require?

The law should define the products in scope (using harmonized definitions) and the regulated parties, set the general rule that only safe, well-performing, good quality devices may be marketed or used, set out the NRA's responsibilities and enforcement powers (restricting circulation, withdrawing products, penalties), ensure accountability across the branches of government, provide for coordination with justice, police and customs, adapt to new technologies, allow reliance and recognition, specify market entry, record-keeping and reporting duties, allow appeals, set realistic transition periods (with guidance during them) and provide for public health emergencies. It should anticipate the expanded-level controls even if they are implemented later.