Today (22 MARCH 2012) Health Canada (HC) has issued to manufacturer’s of record (those mfr’s with a HC License to sell & market product in Canada) a NOTICE titled “ADDITIONAL GUIDANCE ON TRANSITION FROM THE SECOND TO THE THIRD EDITIONS OF THE IEC 60601 FAMILY OF STANDARDS ON HEALTH CANADA’S LIST OF RECOGNIZED STANDARDS.” HC has said that this guidance document will be posted on the HC website by around 1 APRIL 2012. This document is much simpler and more straightforward than the Version 1.1 NB-MED EN 60601-1 3rd ed Implementation FAQ document. (See more details on the NB-MED document by going to our 6 FEB 2012 posting on the subject.)
Currently, HC recognizes both 2nd & 3rd edition of IEC 60601-1. Based on what has been published, before this notice, after June 1, 2012 HC would only accept IEC 60601-1, 3rd ed. with the related Collateral standards (i.e. IEC 60601-1-XX that are aligned with IEC 60601-1, 3rd ed.) and related Particular standards (i.e. IEC 60601-2-XX that are aligned with IEC 60601-1, 3rd ed.). This doesn’t work well as there are some Particular standards that aren’t aligned with 3rd ed., as of yet, or that have only recently (in the last year or so) been published by IEC and so many manufacturers haven’t had the time and/or resources to understand the requirements, do any redesign work, update to their labeling, update their Risk Management File to meet IEC 60601-1, 3rd. ed with any related Collateral & Particular standards, prepare the product for testing (including gathering all appropriate information [component info, etc.] to support the testing), test the product that will hopefully show that the manufacturer complies with all the requirements of the IEC 60601-1, 3rd ed. and the applicable Colateral and Particular standards. That is unless the manufacturer has a lot of resources and are on top of the standards as they are being developed thru IEC and are starting on all this work prior to the applicable standards being published.
So, this HC guidance document sets out the following for the transition rules to be applied as of June 1, 2012:
- If there is no Particular standard that is directly applicable to the device, it should conform to IEC 60601-1:2005 and its applicable Collateral standards.
- If there is a Particular standard(s) that is directly applicable to the device and the version that aligns with IEC 60601-1:2005 was published by IEC before June 1, 2009, then the device should conform to IEC 60601-1:2005 and its applicable Collateral standards in addition to the(se) Particular standard(s).
NOTE: If there are multiple Particular standards that apply to the device you will want to take the latest Particular standard publication date and if that is still before June 1, 2009 use this item 2. If it is after June 1, 2009n then use item 3. - If there is a Particular standard(s) that is directly applicable to the device and the version that aligns with IEC 60601-1: 2005 was published by IEC after June 1, 2009, a three year transition period from the date of publication by IEC will apply. During this transition, HC will accept conformity to both editions and related Collateral standards (and both will be listed on HC’s List of Recognized Standards).
Refer to NOTE in item 2.
These transition rules will not be applied retroactively, meaning that if you have a HC Medical Device License for your product and you used IEC 60601-1, 2nd ed. unless there is a significant change to your product that impacts the characteristics of IEC 60601 series of standards you won’t have to retest to IEC 60601, 3rd ed and submit for an Amended License Application. HC doesn’t require meeting the ‘state of the art’ in the same sense as is stated in the Essential Requirements of Annex I in the EU Medical Device Directive (MDD) or similarly in the Active Implantable Medical Device Directive (AIMDD) so the manufacturer only needs to submit to HC when they have a new medical device that requires a HC license or the manufacturer has to amend their HC medical device license because they have significant change(s) to the product(s) that impact characteristics addressed by the 60601 series of standards.
You still can submit for a HC Medical Device License to 2nd edition of IEC 60601-1 before June 1, 2012 but you will need to make sure it is shipped prior to June 1, 2012.
Standards are voluntary per the CMDR so if you have test data to IEC 60601-1, 2nd ed. and the applicable Particular & Collateral Standards you still could submit this test data to HC after the Transition Rules (items 1 – 3 above) prescribe IEC 60601-1:2005 & applicable standards. The mfr would have to provide a summary of the differences in the testing compared to IEC 60601-1:2005 and provide a rationale to demonstrate that these differences do not affect the validity of the testing in demonstrating of the device’s safety and effectiveness.
The guidance document does state that HC reserves the right to require additional testing deemed necessary to demonstrate safety and effectiveness of any device.
A very important note is stated near the end of the document which says:
” A Medical Device Licence issued by Health Canada provides authorization to import or sell a medical device in Canada and is evidence that the device meets the requirements of the Medical Devices Regulations. Manufacturers are reminded that Provincial or Territorial electrical safety requirements are separate and distinct from the requirements of the Regulations. For further information regarding these requirements, contact the applicable regulatory authorities. A listing of some such authorities is available at: http://www.csa.ca/cm/ca/en/community/electrical/regulators.”