On June 20, 2017, the Center for Medical Device Evaluation of the State Food and Drug Administration issued the Guidelines for the Technical Review of the Registration of Single-use Infusion Pumps (Non-Electrical Drives) and the Technical Review Guidance for the Registration of Blood and Blood Components Storage Bags. Principles - Non-Clinical Evaluation Section" Notice of Solicitation of Comments. The following are the scope of application of the 2 guidelines and the contact information for comments:
Single-use infusion pump (non-electric drive) registration technical review guidelines
This guidance applies to the preparation of a single-use infusion pump (non-electric drive) product registration application and reference to product technical review.
A single-use infusion pump (non-electric drive) refers to a medical device used in a medical institution to input a drug or biological product into a human body in a controlled manner in a controlled manner. The power of the pump is driven by the mechanical power of the device itself. Not driven by other energy. Most of these products are composed of the following components: energy-providing components (non-electrically driven), current limiting devices, reservoirs for containing the infused drug solution, reservoir protection, and drug delivery channels. Liquid filter, flow regulation system, flow stop clamp, self-controlled liquid supply control system, infusion line, etc.
This guideline does not apply to infusion pumps for electric drive or power control, implantable drug delivery devices, enteral nutrition infusion pumps, percutaneous fluid delivery devices, infusions are not powered by the device itself, but through patient intervention. A powered infusion set.
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