收藏网站
新闻中心
首页> 新闻中心 > 正文
FDA经常扣押医疗器械产品信息
发布时间:2006-10-13

FDA经常扣押医疗器械产品信息

 

近期,我们注意到相当数量的出口美国的医疗器械的中国制造商或贸易公司经常有产品被美国海关扣留,很多厂商对FDA注册了解甚少甚至不知道所出口的产品按照美国法律需要进行FDA强制性注册,这不仅影响了正常的交货期,还可能增加不必要的仓储费用甚至产品被美国海关退回或扣押;

 

我们提示下列产品的厂商/贸易商近早联络IRC China, 以便我们为您近早申请FDA注册,为顺利通关提供基本条件:

 

Wooden massager

Vibrators

Body weight scale

Back massager

ADHESIVE BANDAGE

ELASTIC BANDAGES

Medical oxygen generator

Autoclave/Steam  sterilizer

Surgical Mask

Weight scale, sunglasses

MAGNIFYING SPECTACLE

SPECTACLE  FRAME, Laser point

Sterilization Pouches/Pack/Wrap/Bag For Medical

Powered wheelchair

Mechanical wheelchair

ADHESIVE WOUND DRESSING/SURGICAL TAPE

TRANSPARENT DRESSING

TRANSPARENT SEMI-PERMEABLE DRESSING

SURGICAL FILM

Blood Irradiation Indicators

Electrosurgical Control Pencil

Limb holder, protector

Patient examination glove

Rollator with brakes

Unscented menstrual pad

Face Mask/Surgical Mask

First Aid Kit

Medical X-ray Processor

Infrared Ear Thermometer

Digital Clinical thermometer

Sanitary napkin

MERCURY THERMOMETER

Medical Stainless Steel Instrument

Bathroom Series

Rollator, sampler

Ultrasonic file, Eye and Brain Massager

Plastic Clogs

Medical degrease gauze

Medical  scissors

STETHOSCOPE

Surgical apparel

Surgical Towel

Gauze

Swabs

Lap Sponges

Microscope lamps

Colposcope

Disposable Preparation Razor Kit

Catheterization Assistance Kit

Condom

Urine Bag

Homecare beds

Fingertip Oximeter

MRI Coil

HCG Urine Strip

Surgicel Absorbable Hemostat

Natural Biological Protein Suture

Compressor Nebulizer

Contact lens case

Stretcher

Vaginal Dilator for Single Use

Computer controlled shampooing & bathing trolley

Electronic Auto-controlled Tower Trolley

Medical lift stretcher trolley

MEDICAL ELECTRONIC AUTO-CONTROLLED AIR MATTRESS

Blood Line Set

Ultrasonic Scaler

Scalpel

Cutter

Suture  needle

Suture

IV Bag

Dental instruments

Ultrasonic Diagnostic Device for Ophthalmology

Pisoton syringe& Hypodermic single lumen needle

Surgical Gown

Surgical Mask

Surgical Drape

Sphygmomanometer

等等。

 

大部分一类产品可直接通过授权被FDA列名的FDA注册事务美国代理人US Agent进行制造商/设施注册Establishment Registration NumberFDA拥有权人注册Owner Number和产品/器械列名Device Listing;2类产品需要通过先申请FDA510(K)号码才能进行公司注册和产品列名。

 

International Regulatory Consultants, LLC (IRC)是被FDA官方列名的提供美国代理人服务(US Agent)的美国代理人,与其他以食品和药品为主要业务的代理人不同,IRC仅活跃于医疗器械FDA注册和美国代理人服务领域,所以我们更求提供专业和务实的服务;为国内厂商顺利开拓美国市场提供坚实的基础;

 

欲了解进一步信息,请访问我们网站的其他介绍或与我们的中国服务代表联络,我们会热忱为您提供解答。感谢您的支持和信任,期待您的问讯!

 

IRC编译整理

www.FDAChina.com