Dubai Medical devices Regulations

Management Forum Ltd - Woking, United Kingdom - Local Business

List of consulting services to quality systems.

In Canada, the medical device market is regulated by Health Canada. Manufacturers of Class II, III and IV must meet the quality system requirements of ISO 13485:2003. Companies that do not by a Health Canada CMDCAS accredited registrar are certified (link in English) ISO 13485:2003, can not sell their products in Canada.

Health Canada requires manufacturers of Class II, III and IV also that these make an application for a medical license (Medical Device Licence, MDL). Applications for products in classes II and III are similar to those of a 510 (k) application to the U.S. FDA. The application for Class IV is usually more expensive than a regular 510 (k) submission, but less complex than an application with the U.S. FDA for a permit before the launch (Premarket Approval, PMA).

Emergo Group specializes in the support of medical device and IVD companies comply with the Canadian Medical Device Regulations (Canadian Medical Devices Regulations, CMDR) to tap this pretty big market. We can assist you in implementing or adapting an ISO 13485:2003 quality system and your medical device license application help to make you comply with the Canadian Medical Device Regulations (Canadian Medical Devices Regulations, CMDR) completely.

Emergo Group has helped hundreds of medical device manufacturers in complying with the Canadian Medical Devices Regulations (CMDR).

For more information about our consulting services to the Health Canada CMDR will be provided upon request.

China Medical Science and Technology Press Technical basis of medical device regulation(Chinese Edition)
Book (China Medical Science and Technology Press)
2013-03-20 12:19:34 by flaveur

"Obamacare" ..jobs destroyed in NY, WI, MA, etc.

Smith & Nephew Orthopedics is laying off an estimated 100 employees in Memphis and Andover, Mass., citing the 2.3% excise tax on orthopedic device companies as the reason.
Medical Device Tax: Cook Medical scuttles midwest expansion plans over levy
Cook Medical says it will not proceed on plans to open 5 new facilities in the midwest because of concerns about the medical device tax.
The company will likely pay between $20 to $30 million once the 2.3% excise tax takes effect in January, 2013

2013-03-20 12:20:55 by flaveur

Um, it's actual closings and layoffs. Hello?

Smith & Nephew Orthopedics is laying off an estimated 100 employees in Memphis and Andover, Mass., citing the 2.3% excise tax on orthopedic device companies as the reason.
Medical Device Tax: Cook Medical scuttles midwest expansion plans over levy
Cook Medical says it will not proceed on plans to open 5 new facilities in the midwest because of concerns about the medical device tax.
The company will likely pay between $20 to $30 million once the 2.3% excise tax takes effect in January, 2013

You might also like:

Make Money on Blogger with Google AdSense
Make Money on Blogger with Google AdSense
Medical Device Recruiter "blows whistle" on ST. JUDE Medical
Medical Device Recruiter "blows whistle" on ST. JUDE Medical
My Naked Secret: Seeing a Woman
My Naked Secret: Seeing a Woman

China: life sciences regulatory crackdown spreads to medical device sector  — Lexology
On August 15, 2013, the local Beijing office of the Ministry of Health (MOH) of the People's Republic of China announced (Chinese link) that it has started a three-month review of the use of high-value medical consumables and large-scale medical ..

HYDROMER, INC. : Enters into Supply Agreement with a Chinese Medical ..  — 4-traders
BRANCHBURG, NJ, August 26, 2013 -(ACCESSWIRE)- Hydromer, Inc. (OTC Pink: HYDI) and a Chinese Medical Device company have entered into a Supply and Support Agreement. Under the terms of this agreement, the Chinese ..

NSystems LLC Hypertension and Total Therapy Device Medicomat-7 Electro Acupuncture Treatment Therapy Pain Device Healthcare Online Lower High Blood Pressure Rehabilitation Supplies Free Health Care Regulation Of Blood System Anti Aging Device Low Back Pain Rheumatoid Arthritis Diabetes Treatment Pain Relief Auricular Ear Acupuncture Points Equipment Foot Massager Stress Therapies High Effective Alternative Chinese Therapy Relaxation Massage And Spa Electroacupuncture Best Portable Music Massage Treatment
Health and Beauty (NSystems LLC)
  • Medicomat® Medical Automat Series
  • THE WORLD S BEST HEALTHCARE APPARATUS
  • Hypertension and Total Therapy Machine
  • Fully Automatic Treatment at Home
  • Blood Pressure Depressor
  • Read more and view product video at Medicomat.com
  • Extra Shipping Bonus: pay only the minimum Standard shipping rate and get Faster delivery services worldwide.Delivery is by EMS (Express Mail Service) to 55 countries...
  • Why is the BEST?
  • Overall Therapy
  • Natural Therapy

Related posts: