WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 7.6-donations: Donors ensure donated devices meet the receiving country's requirements, respond to an expressed clinical need, are complete, documented in a local language, suited to local conditions and skills, have adequate shelf life and come with a disposal plan, and obtain import authorization before shipment

What does 7.6-donations require?

Whoever donates (charity, company or individual), in consultation with the recipient, is responsible for making sure donated devices comply with the receiving country's regulations, the same as devices from the normal supply chain, including in emergencies. Donated devices should respond to a genuine clinical need that end users asked to meet, carry authorization from the receiving regulator or meet current international safety standards, include all parts and accessories, come with documentation in a language understood locally, suit local conditions such as power supply and local skills (or come with training), have reasonable remaining shelf life, and arrive with a disposal plan. Import documents (product list, labels, manufacturer details, evidence of authorization or QMS certificate for high-risk devices, expiry dates and a commitment letter with proof of proper functioning) must be submitted to the recipient's NRA before shipment; non-compliant donations may be returned at the donor's expense.