What are the products in the catalogue of key regulatory varieties for medical device production?

The "Guiding Opinions of the Comprehensive Department of the State Food and Drug Administration on Strengthening the Grading Supervision and Administration of Medical Device Production and Operation" has made important arrangements for the quality supervision and management of medical device production and operation enterprises, so which products in medical device production and operation enterprises are key regulatory products? Neurological and cardiovascular surgical instruments - cardiovascular interventional instruments products include contrast catheters, catheter guides, central venous catheters, perfusion catheters, balloon dilation catheters, contrast balloons, occludal balloons, thrombotic suction catheters, manule peripheral catheters, catheter sheaths, microcatheters, etc
.
Injection and puncture equipment products include sterile syringes, needle-free syringes, pen syringes, injection needles (excluding disposable unsterilized injection needles).

There are infusion auxiliary electronic devices in the intravascular infusion device (used to increase some auxiliary functions such as flow control, heating, alarm and other functions during the infusion process of analgesics, chemotherapy drugs, and insulin fluids
.
), passive infusion pumps, intravenous infusion needles, intravascular indwelling needles, implantable drug delivery devices, infusion bags
.
Non-vascular infusion devices include insulin pumps, subcutaneous infusion devices for insulin pumps, and reservoirs for insulin pumps
.
The testing equipment required for cardiovascular surgical instruments is CX0285-C suction pressure tester, ZS0285-C catheter power injection flow and pressure tester, DT 0332-C dynamic fracture strength tester, BP0285-C static pressure burst tester, XB0489-C drainage system component anti-deformation tester, XL0285-C liquid leakage tester under pressure, YY0339-C catheter vacuum residue/leakage tester, YY0540-C guide wire bending performance tester, balloon reliability tester, LL0285-C catheter flow tester, XL0461-C pipeline leakage tester, firmness separation tester, 6% Luer cone joint multi-function tester and other catheter series tester
。 The testing equipment required for injection and puncture equipment products is ZY15810-C syringe tightness positive pressure tester, FY15810-C syringe tight negative pressure tester, TL0573-C syringe piston thrust tester, HX15810-C syringe sliding performance tester, HT0573-C to prevent reuse of thrust tester, syringe self-destruct characteristic tester, injection needle simulation skin, CL15811-C medical injection needle tip puncture tester, RX9626-C medical injection needle tube (needle) toughness tester, GX9626-C medical injection needle tube (needle) rigidity tester, LG15811-C breaking force/connection firmness tester, LG15811-T injection needle firmness tester, injection needle breaking force tester and other injection needle tester series and syringe tester series products
。 The testing equipment required for intravascular infusion instruments and products include YY0451-T infusion pump flow parameter tester, intravenous needle penetration force tester, intravenous needle rigidity tester, intravenous infusion needle toughness tester, SZF8368-C infusion device leakage positive and negative pressure tester, SZ8368-C infusion device leakage positive pressure tester, SF8368-C infusion device leakage negative pressure tester, indwelling needle tip piercing force tester, indwelling needle rigidity tester, indwelling needle toughness tester, Connection firmness tester, 6% Luer tapered joint multi-function tester, etc
.
The above contents of the catalogue of key regulatory varieties of medical device production are provided by Weixia Technology originally, hoping to help
you.