WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 6.3.3.4-local: Government and NRA: support quality local production with good regulatory practice, apply the same controls to local and imported devices, offer pre-submission meetings and impartial technical support, and inspect local plants

What does 6.3.3.4-local require?

Governments may promote local device manufacturing, but local manufacturers should face the same consistent, impartial controls as imported products. The NRA should advise government on supportive policies, adopt international standards as national standards and publish recognised lists, provide impartial technical support and voluntary pre-submission meetings, publish concise rules applying equally to local and foreign manufacturers, issue timely risk-based authorizations, take part in regional reliance initiatives, normally inspect local plants and warehouses itself, investigate and coordinate abroad on exported locally made devices, and take graded enforcement from warning letters to closure.