美國 GMP認證辦理難點、時長

GMP認證流程、需求、時長、和費用

1、確認GMP認證需求來源，GMP認證需求是來源于客戶及哪一個品牌的客戶。

2、 確認GMP認證依據(jù)

3、工廠建立，運行，保持GMP體系，內(nèi)審和管審

4、GMP認證申請

5、GMP認證實施

6、GMP 認證跟進

7、GMP認證證書發(fā)放

8、GMP認證證書維持和年度監(jiān)督跟進。

9、GMP認證時長，我公司一般三個月時間可以獲證。

10、費用依據(jù)FDA官方收費標準為依據(jù)，我司代理費來電注明順企網(wǎng)有更多優(yōu)惠！

11 FAD   通用醫(yī)院和個人使用的醫(yī)療器械是什么？ FDA 分類目錄 880 即為通用醫(yī)院和個人使用的醫(yī)療器械。

PART 880

GENERAL HOSPITAL AND PERSonAL USE DEVICES

Subpart A - General Provisions
   § 880.1 - Scope.

§ 880.3 - Effective dates of re for premarket approval.
   § 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B [Reserved]

Subpart C - General Hospital and Personal Use Monitoring Devices
   § 880.2200 - Liquid crystal forehead temperature strip.
   § 880.2400 - Bed-patient monitor.
   § 880.2420 - Electronic monitor for gravity flow infusion systems.
   § 880.2460 - Electrically powered spinal fluid 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 for estimation of external blood loss.
   § 880.2800 - Sterilization process indicator.
   § 880.2900 - Clinical color change thermometer.
   § 880.2910 - Clinical electronic thermometer.
   § 880.2920 - Clinical mercury thermometer.
   § 880.2930 - Apgar timer.

Subparts D-E [Reserved]

Subpart F - General Hospital and Personal Use Therapeutic Devices
   § 880.5025 - I.V. container.
   § 880.5045 - Medical recirculating air cleaner.
   § 880.5075 - Elastic bandage.
   § 880.5090 - Liquid bandage.
   § 880.5100 - AC-powered adjustable hospital bed.
   § 880.5110 - Hydraulic adjustable hospital bed.
   § 880.5120 - Manual adjustable hospital bed.
   § 880.5130 - Infant radiant warmer.
   § 880.5140 - Pediatric medical crib.
   § 880.5145 - Medical bassinet.
   § 880.5150 - Nonpowered flotation therapy mattress.

emergencies.
   § 880.6265 - Examination gown.
   § 880.6280 - Medical insole.
   § 880.6300 - Implantableuency transponder system for patient identification and health information.
   § 880.6305 - Ingestible event marker.
   § 880.6310 - Medical device data system.
   § 880.6315 - Remote Medication Management System.
   § 880.6320 - AC-powered medical examination light.
   § 880.6350 - Battery-powered medical examination light.
   § 880.6375 - Patient lubricant.
   § 880.6430 - Liquid medication dispenser.
   § 880.6450 - Skin pressure protectors.
   § 880.6500 - Medical ultraviolet air purifier.
   § 880.6600 - Ultraviolet (UV) radiation chamber disinfection device.
   § 880.6710 - Medical ultraviolet water purifier.
   § 880.6730 - Body waste receptacle.
   § 880.6740 - Vacuum-powered body fluid suction apparatus.
   § 880.6760 - Protective restraint.
   § 880.6775 - Powered patient transfer device.
   § 880.6785 - Manual patient transfer device.
   § 880.6800 - Washers for body waste receptacles.
   § 880.6820 - Medical disposable scissors.
   § 880.6850 - Sterilization wrap.
   § 880.6860 - Ethylene oxide gas sterilizer.
   § 880.6870 - Dry-heat sterilizer.
   § 880.6880 - Steam sterilizer.
   § 880.6885 - Liquid chemical sterilants/high level disinfectants.
   § 880.6887 - Spore test strip.
   § 880.6890 - General purpose disinfectants.
   § 880.6900 - Hand-carried stretcher.
   § 880.6910 - Wheeled stretcher.
   § 880.6920 - Syringe needle introducer.
   § 880.6960 - Irrigating syringe.
   § 880.6970 - Liquid crystal vein locator.
   § 880.6980 - Vein stabilizer.
   § 880.6990 - Infusion stand.
   § 880.6991 - Medical washer.
   § 880.6992 - Medical washer-disinfector.    § 880.5160 - Therapeutic medical binder.
   § 880.5180 - Burn sheet.
   § 880.5200 - Intravascular catheter.
   § 880.5210 - Intravascular catheter securement device.
   § 880.5240 - Medical adhesive tape and adhesive bandage.
   § 880.5270 - Neonatal eye pad.
   § 880.5300 - Medical absorbent fiber.
   § 880.5400 - Neonatal incubator.
   § 880.5410 - Neonatal transport incubator.
   § 880.5420 - Pressure infusor for an I.V. bag.

§ 880.5430 - Nonelectrically powered fluid injector.
   § 880.5440 - Intravascular administration set.
   § 880.5445 - Intravascular administration set, automated air removal system.
   § 880.5450 - Patient care reverse isolation chamber.
   § 880.5475 - Jet lavage.
   § 880.5500 - AC-powered patient lift.
   § 880.5510 - Non-AC-powered patient lift.
   § 880.5550 - Alternating pressure air flotation mattress.
   § 880.5560 - Temperature regulated water mattress.
   § 880.5570 - Hypodermic single lumen needle.
   § 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 enabled infusion pump.
   § 880.5740 - Suction snakebite kit.
   § 880.5760 - Chemical cold pack snakebite kit.
   § 880.5780 - Medical support stocking.
   § 880.5820 - Therapeutic scrotal support.
   § 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 Miscellaneous Devices
   § 880.6025 - Absorbent tipped applicator.
   § 880.6050 - Ice bag.
   § 880.6060 - Medical disposable bedding.
   § 880.6070 - Bed board.
   § 880.6080 - Cardiopulmonary resuscitation board.
   § 880.6085 - Hot/cold water bottle.
   § 880.6100 - Ethylene oxide gas aerator cabinet.
   § 880.6140 - Medical chair and table.
   § 880.6150 - Ultrasonic cleaner for medical instruments.
   § 880.6175 - [Reserved]
   § 880.6185 - Cast cover.
   § 880.6190 - Mattress cover for medical purposes.
   § 880.6200 - Ring cutter.
   § 880.6210 - Sharps needle destruction device.
   § 880.6230 - Tongue depressor.
   § 880.6250 - Non-powdered patient examination glove.
   § 880.6260 - Filtering facepiece respirator for use by the general public in public health medical 

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