ISO 13485

What’s ISO 13485?
Effective quality management systems are recognized as a key regulatory consideration for allowing medical device manufacturers to market their products around the world. ISO 13485 provides a focus for the quality management system requirements for medical device manufacturers.

The ISO 13485 Standard will eventually become the “de facto” standard in Europe and the present EN 46001 Standard will be withdrawn.

Who is getting registered to ISO 13485?
The Canadian Government and Health Canada have not backed down from the requirement that all manufacturers of medical devices exporting into Canada MUST be registered to the ISO 13485/88 standards. While we are not attempting to bore you with repeated facts, the requirement is now in place in Canada. As a reminder, if your products are already licensed with Health Canada, you must submit valid ISO 13488 (Class II) and ISO 13485 (Class III and IV) quality management certificates to Health Canada as a requirement by November, 2003-04. Those companies with new devices or those who are not licensed with Health Canada as of January, 2003-04, must submit the above ISO certificates upon registration.

It is expected that the new ISO 13485/88 standards will go into effect with a 3 year transition to 2006. Companies who are currently registered under the ISO 9000:2000 standard and who need to be registered against 13485/88 should consider the transition to the new ISO 9001:2000 and the new ISO 13485/88 without hesitation. It would be beneficial to you to be registered simultaneously to both standards now. Keep in mind that only certain notified bodies are certified by Health Canada. This certificate can be issued only by a Canadian recognized Notified Body.