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Insight Report Vol. 8- No.8

Will compliance to ISO-13485 assure you that you will also meet the Canadian Standards? Don’t bet on it!

mdi has been working closely with many medical device manufacturers assisting them in upgrading their ISO9001 system to meet the ISO13485 standard. Now comes along the new Canadian standards that companies also need to meet to be able to maintain their Canadian certification. The audit to the Canadian standards is usually conducted by a recognized registrar/notifying body that is qualified in the Canadian Medical Devices Conformity Assessment System (CMDCAS).

Companies have to understand that just because they meet the 13485 standard does not mean they will meet all the additional requirements for the Canadian standards also. This might appear to be a real “pain in the neck” but unfortunately with everyone making sure that they can demand a piece of the regulatory pie manufacturers will have to learn to deal with these different government departments.

We have been recently involved with several companies who have had their audits for ISO13485 along with the Canadian certification. The following are several areas that we have been running into where those companies thought that their ISO13485 upgrade would also pass the Canadian requirements but didn’t:

a. A procedure regarding the classification of devices in accordance with Schedule 1 of the Health Canada Medical Devices Regulations was missing

b. No evidence was shown to establish that the device was in conformance with sections 10-20 of the Health Canada Medical Device Regulations.

c. Procedures were not presented for audit that document distribution records in accordance with Sections 52, 53, 54, 55 and 56 parts of the Canadian Medical Device Regulations

d. Recall procedures, as defined in Section 63, 64 and 65 of the Health Canada Medical Device Regulations were missing

e. Procedures were not presented for audit regarding the Mandatory Problem Reporting in compliance with Sections 59, 60, 61 and 62 of the Health Canada Medical Device Regulations

f. There were no complaint handling procedures as defined in Sections 57 and 58 of the Health Canada Medical Device Regulations

g. There was no procedure for auditing the application (Section 32), renewal (Section 43) or amendment (Section 43) of product licenses for Canada

h. There was no procedure to control implantable devices (if applicable) in accordance with sections 66, 67 and 68 of the Health Canada Medical Device Regulations

i. Their Quality Manual or their internal audit procedures do not consider the requirements of the Canadian Standard ISO 13485:2003 or the Canadian Medical Device regulations.

j. No evidence was shown to establish that the safety and effectiveness of the device was determined in accordance with Section 9 of the Health Canada Medical Device Regulations

k. Manufacturers did not address the labeling of devices to be sold in the Canadian market in accordance with Sections 21-23 of the Health Canada Medical Device Regulations

l. There was no license available for devices to be sold in the Canadian market. (Class II, III and IV devices can obtain such a license only after being certified by an authorized registrar)

Companies work hard to keep up with all these standards. It is even harder to keep in compliance with them. Complying with ISO13485 standards definitely establishes the basic framework needed for compliance; however, the additional effort to conform to Canadian standards needs to be addressed fully to assure that your Canadian certification can be maintained.

We’d like to hear from you on how you enjoyed our Insight Report. insight@mdiconsultants.com

Next Insight Report - to be announced.

If you have any comments on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.
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