美国 GMP认证办理难点、时长

GMP认证流程、需求、时长、和费用

1、确认GMP认证需求来源，GMP认证需求是来源于客户及哪一个品牌的客户。

2、 确认GMP认证依据

3、工厂建立，运行，保持GMP体系，内审和管审

4、GMP认证申请

5、GMP认证实施

6、GMP 认证跟进

7、GMP认证证书发放

8、GMP认证证书维持和年度监督跟进。

9、GMP认证时长，我公司一般三个月时间可以获证。

10、费用依据FDA官方收费标准为依据，我司代理费来电注明顺企网有更多优惠！

11 FAD   通用医院和个人使用的医疗器械是什么？ FDA 分类目录 880即为通用医院和个人使用的医疗器械。

PART 880

GENERAL HOSPITAL AND PERSONAL USE DEVICES

Subpart A - General Provisions
   § 880.1 - Scope.

§ 880.3 - Effective dates of requirement for premarketapproval.
   § 880.9 - Limitations of exemptions fromsection 510(k) of the Federal Food, Drug, and Cosmetic Act (theact).

Subpart B [Reserved]

Subpart C - General Hospital and Personal Use MonitoringDevices
   § 880.2200 - Liquid crystal foreheadtemperature strip.
   § 880.2400 - Bed-patient monitor.
   § 880.2420 - Electronic monitor for gravityflow infusion systems.
   § 880.2460 - Electrically powered spinalfluid pressure monitor.
   § 880.2500 - Spinal fluid manometer.
   § 880.2700 - Stand-on patient scale.
   § 880.2720 - Patient scale.
   § 880.2740 - Surgical sponge scale.
   § 880.2750 - Image processing device forestimation of external blood loss.
   § 880.2800 - Sterilization processindicator.
   § 880.2900 - Clinical color changethermometer.
   § 880.2910 - Clinical electronicthermometer.
   § 880.2920 - Clinical mercurythermometer.
   § 880.2930 - Apgar timer.

Subparts D-E [Reserved]

Subpart F - General Hospital and Personal Use TherapeuticDevices
   § 880.5025 - I.V. container.
   § 880.5045 - Medical recirculating aircleaner.
   § 880.5075 - Elastic bandage.
   § 880.5090 - Liquid bandage.
   § 880.5100 - AC-powered adjustable hospitalbed.
   § 880.5110 - Hydraulic adjustable hospitalbed.
   § 880.5120 - Manual adjustable hospitalbed.
   § 880.5130 - Infant radiant warmer.
   § 880.5140 - Pediatric medical crib.
   § 880.5145 - Medical bassinet.
   § 880.5150 - Nonpowered flotation therapymattress.

emergencies.
   § 880.6265 - Examination gown.
   § 880.6280 - Medical insole.
   § 880.6300 - Implantable radiofrequencytransponder system for patient identification and healthinformation.
   § 880.6305 - Ingestible event marker.
   § 880.6310 - Medical device data system.
   § 880.6315 - Remote Medication ManagementSystem.
   § 880.6320 - AC-powered medical examinationlight.
   § 880.6350 - Battery-powered medicalexamination light.
   § 880.6375 - Patient lubricant.
   § 880.6430 - Liquid medicationdispenser.
   § 880.6450 - Skin pressure protectors.
   § 880.6500 - Medical ultraviolet airpurifier.
   § 880.6600 - Ultraviolet (UV) radiationchamber disinfection device.
   § 880.6710 - Medical ultraviolet waterpurifier.
   § 880.6730 - Body waste receptacle.
   § 880.6740 - Vacuum-powered body fluidsuction apparatus.
   § 880.6760 - Protective restraint.
   § 880.6775 - Powered patient transferdevice.
   § 880.6785 - Manual patient transferdevice.
   § 880.6800 - Washers for body wastereceptacles.
   § 880.6820 - Medical disposablescissors.
   § 880.6850 - Sterilization wrap.
   § 880.6860 - Ethylene oxide gassterilizer.
   § 880.6870 - Dry-heat sterilizer.
   § 880.6880 - Steam sterilizer.
   § 880.6885 - Liquid chemical sterilants/highlevel disinfectants.
   § 880.6887 - Spore test strip.
   § 880.6890 - General purposedisinfectants.
   § 880.6900 - Hand-carried stretcher.
   § 880.6910 - Wheeled stretcher.
   § 880.6920 - Syringe needle introducer.
   § 880.6960 - Irrigating syringe.
   § 880.6970 - Liquid crystal veinlocator.
   § 880.6980 - Vein stabilizer.
   § 880.6990 - Infusion stand.
   § 880.6991 - Medical washer.
   § 880.6992 - Medicalwasher-disinfector.    § 880.5160 -Therapeutic medical binder.
   § 880.5180 - Burn sheet.
   § 880.5200 - Intravascular catheter.
   § 880.5210 - Intravascular cathetersecurement device.
   § 880.5240 - Medical adhesive tape andadhesive bandage.
   § 880.5270 - Neonatal eye pad.
   § 880.5300 - Medical absorbent fiber.
   § 880.5400 - Neonatal incubator.
   § 880.5410 - Neonatal transportincubator.
   § 880.5420 - Pressure infusor for an I.V.bag.

§ 880.5430 - Nonelectrically powered fluid injector.
   § 880.5440 - Intravascular administrationset.
   § 880.5445 - Intravascular administrationset, automated air removal system.
   § 880.5450 - Patient care reverse isolationchamber.
   § 880.5475 - Jet lavage.
   § 880.5500 - AC-powered patient lift.
   § 880.5510 - Non-AC-powered patientlift.
   § 880.5550 - Alternating pressure airflotation mattress.
   § 880.5560 - Temperature regulated watermattress.
   § 880.5570 - Hypodermic single lumenneedle.
   § 880.5580 - Acupuncture needle.
   § 880.5630 - Nipple shield.
   § 880.5640 - Lamb feeding nipple.
   § 880.5680 - Pediatric position holder.
   § 880.5700 - Neonatal phototherapy unit.
   § 880.5725 - Infusion pump.
   § 880.5730 - Alternate controller enabledinfusion pump.
   § 880.5740 - Suction snakebite kit.
   § 880.5760 - Chemical cold pack snakebitekit.
   § 880.5780 - Medical support stocking.
   § 880.5820 - Therapeutic scrotalsupport.
   § 880.5860 - Piston syringe.
   § 880.5950 - Umbilical occlusion device.
   § 880.5960 - Lice removal kit.
   § 880.5965 - Subcutaneous, implanted,intravascular infusion port and catheter.
   § 880.5970 - Percutaneous, implanted,long-term intravascular catheter.

Subpart G - General Hospital and Personal Use MiscellaneousDevices
   § 880.6025 - Absorbent tippedapplicator.
   § 880.6050 - Ice bag.
   § 880.6060 - Medical disposable bedding.
   § 880.6070 - Bed board.
   § 880.6080 - Cardiopulmonary resuscitationboard.
   § 880.6085 - Hot/cold water bottle.
   § 880.6100 - Ethylene oxide gas aeratorcabinet.
   § 880.6140 - Medical chair and table.
   § 880.6150 - Ultrasonic cleaner for medicalinstruments.
   § 880.6175 - [Reserved]
   § 880.6185 - Cast cover.
   § 880.6190 - Mattress cover for medicalpurposes.
   § 880.6200 - Ring cutter.
   § 880.6210 - Sharps needle destructiondevice.
   § 880.6230 - Tongue depressor.
   § 880.6250 - Non-powdered patientexamination glove.
   § 880.6260 - Filtering facepiece respiratorfor use by the general public in public health medical 

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