ARTICLE SUMMARY:
New guidelines on devices from outside contractors. Excerpted from Pathways’ Picks April 10: Reliance in Brazil, Manufacturing in China, Reprocessing in the EU, and More.
China’s National Medical Products Administration outlined procedures for device authorization holders to maintain quality and safety controls for devices that are manufactured by outside contractors in an April 3 guideline (link in Simplified Chinese). Reforms in 2021 gave domestic and foreign companies more flexibility to work with contract manufacturers in China without having to pursue a new device approval, but the change came with strict requirements to ensure the original company maintains quality control. The new policy guideline underscores those mandates and details the need for companies to vet entrusted manufacturers and work closely with them on issues including corrective and preventive actions, supplier controls, and batch release. The authorization holder retains full responsibility for adverse event reporting, the policy stresses, and it clarifies the role of provincial authorities to audit both production sites and authorization holders. The policy also reiterates that registrants are encouraged to manufacture implantable devices in-house, but if they must contract out, extra care is necessary.