European Medical Device Companies

1fdareport0422.jpg

Chapter 2: The Canadian requirements

Information archived on the Web

Information identified as archived on the Web is for reference, research or recordkeeping purposes. It has not been altered or updated after the date of archiving. Web pages that are archived on the Web are not subject to the standards applicable to the Government of Canada Web. In accordance with the Communications Policy of the Government of Canada , you can request alternate forms. Ending the page " Contact Us "

Overview of the requirements of the quality system requirements for the sale of medical devices in Canada

Health Canada, under the provisions of the Food and Drugs Act, regulates the sale of medical devices and drugs in Canada. The new regulations on medical devices ("the Regulations") came into force on 1 July 1998, replacing Regulation applied since 1975. These regulations are amended as necessary to reflect new policies and minor changes that affect them. We can see from a codified version of the site: This regulation is based on principles of assessment and risk management and a balanced approach to examination before the placing on the market, quality and monitoring systems after the placing on the market.

The first system used to classify in vitro diagnostic devices, while the second system is concerned with all the other instruments and covers the majority of the instruments available in Canada. Both systems classify instruments into four risk classes, Class I being the instruments with the lowest risk and Class IV instruments with the highest risk. To assign a level of risk medical devices other than in vitro diagnostic products, we use criteria such as the invasiveness of the instrument, the duration of the break, the body part that is in contact with instrument, or if the operation of the instrument depends on whether or not a source of energy, if the instrument is used for diagnostic or therapeutic purposes and the instrument can transmit energy or not the patient . Special rules are provided to classify devices incorporating, for example, animal tissue or whose manufacture uses a recombinant DNA technology.

A set of requirements for safety and effectiveness underlying the Regulations. These requirements have been shaped according to the "essential requirements" of European directives. In most cases, compliance with Health Canada regarding the requirements is evaluated through a licensing requirement before the placing on the market, but all instruments must respond adequately to requirements of safety and effectiveness, as appropriate.

Before a medical device class II, III or IV can be imported, sold or advertised for sale, it is necessary to hold a license from Health Canada. For cons, the Class I devices are not subject to these requirements for granting approval. Although it is for manufacturers to classify instruments, classification should be evaluated by Health Canada. In addition, the amount of information to be submitted for obtaining a license increases the risk level of the instrument.

To monitor the distribution of a medical device, the manufacturing phase to the use phase, importers and distributors must obtain an establishment license. The manufacturers of medical devices class I instruments that directly distribute users must also obtain a business license.


tadalafil tablets 20 mg dosage
Mosby Assistive Technologies: Principles and Practice (2nd Edition)
Book (Mosby)
2013-04-12 11:26:57 by flaveur

Wow, where to begin? We'll start with "reform."

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

2013-03-10 11:09:53 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

2013-04-12 07:41:44 by flaveur

79 in favor ... that's quite bipartisan, huh?

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 12:23:58 by flaveur

Actual layoffs are "opinion"? How so?

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:

NewScientist.com: News
NewScientist.com: News

Veteran voices caution for women in the military  — Press Pubs
She signed up to become a medic because she had a bit of prior medical training as a lifeguard and it sounded more exciting than other options such as working in a kitchen or an office. After training she was sent to a small ..

Fueling the entrepreneurial spirit  — Harvard Gazette
HMS student Marc Succi, who recently founded a medical device company, said the entrepreneurial spirit is also alive and well among the student body at the Medical School.

Progressive Progressive GT-3520 International 19-Piece Measuring Cup and Spoon Set
Kitchen (Progressive)
  • Comprehensive 19-piece kitchen measuring set in red, white and gray; standard and metric measurements
  • Cup measurements: 1/8, 1/4, 1/3, 1/2, 2/3, 3/4, 1, 1-1/2, 1-3/4, and 2 cups
  • Spoon measurements: 1/32 tsp, 1/16 tsp, 1/8 tsp, 1/4 tsp, 1/2 tsp, 1 tsp, 2 tsp, 1/2 Tbls, and 1 Tbls
  • Large handles provide a more secure grip
  • All pieces are dishwasher safe
Emgee Nostalgia Electrics RHD800 Retro Series Hot Dog Roller
Kitchen (Emgee)
  • Five non-stick rollers rotate continuously to evenly cook hot dogs, sausages, breakfast links and more
  • Holds up to eight regular-sized or four foot-long hot dogs at one time
  • Removable stainless steel rollers and drip tray for easy cleaning
  • Built-in bun warmer on top
  • Great retro styling is perfect for game rooms, theater rooms, picnics and more
Emgee Nostalgia Electrics JFD100 Cake Pop & Donut Hole Bakery
Kitchen (Emgee)
  • Makes up to 7 cake pops, donut holes, or savory treats
  • Non-stick coating for easy cooking and clean-up
  • Includes 25 bamboo cake pop sticks
  • Recipes included for donuts, muffins, brownies bites and more
  • Cooking time between 5-7 minutes
Chef Buddy Chef Buddy Cool Touch Microwave Bowl
Kitchen (Chef Buddy)
  • 3-Piece set: ceramic bowl, microwave bowl holder, vented lid
  • Large 24-ounce capacity
  • Dimensions: 9-1/4-inch by 7-inch by 3.625-inch
  • Dishwasher safe
  • 3-Piece set

Related posts: