Monthly Archives: June 2011

Medical Electrical Device (MED) companies are required to adopt IEC 60601-1 edition 3 in 2012.  The timeline to adopt to the new standard is as follows:

Europe: June 1, 2012
Canada: June 1, 2012
USA: July 1, 2013

This standard requires more in depth Risk Analysis, consistent with ISO 14971:2007 requirements covering product lifecycle in addition to re-testing the device to 60601-1 edition 3. The Risk Management Audit part of the compliance consists of full review of implementation of ISO 14971 which requires addressing all elements as required by this standard.

The following steps need to be taken to comply with 60601-1 edition 3:

• Familiarize yourself with the standard
• Revise your Risk Management File to ensure it is consistent with ISO 14979:2007
• Update your design file to cover risk management requirements
• Retest the device to IEC 60601-1 edition 3

As of September 1, 2011, Manufacturers, importers and distributors of medical device software and facilities that purchase patient management software must comply with Health Canada Medical Device Regulations, including the requirement for a valid ISO 13485 (CMDCAS) Quaity System Certification. Any changes made to the device must be consistent with paragraph 34 of Health Canada Medical Device Regulations.
It is therefore important for your organization to ensure that your Patient Management Software is licensed for sale or use within Canada.

Class I: Manufacturers, importers or distributors of a Class I medical device selling directly (not through distributor) need to secure a Medical Device Establishment License (MDEL). Form – 0292 is used for MDEL application.
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/licences/form/frm-0292-eng.pdf
Class II, III & IV: Manufacturers, importers or distributors of Class II, Class III and Class IV must secure a Medical Device License (MDL).
Certification of the quality management system to ISO 13485 and CMDCAS is required for all organizations seeking MDL for all medical devices sold in Canada.
To apply for Class II the following form must be submitted to HC:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/md-im/applic-demande/form/licapp_demhom_cla2-eng.pdf

For class III and IV the procedure is more complicated and must be addressed on a case by case situation, the scope of documentation is similar to 510k clearance.
Private Label: If you wish to private label a medical device you need to comply with HC regulations for Private Labelling:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/md-im/label_marque_pri-eng.pdf

Private label manufacturers must apply for and obtain a medical device licence (MDL) in order to sell their Class II, III or IV private label medical devices in Canada.

If your company has been registered for number of years and you would like to improve your quality management system further, perhaps you should consider implementation of ISO 9004:2009.
The ISO 9004 series have always been used hand in hand with, and as an implementation guide to ISO 9001, but since the 2009 edition, the ISO 9004 has had the life of its own. ISO 9004:2009 in addition to being an excellent guide to implementation of quality management system is also a full-fledged standard that can be implemented on its own.
By looking at the body of ISO 9004:2009 it is evident the direction that the standard is taking, by inclusion of the following, in addition to provide guidance on enhancement of ISO 9001 standard:
– Sustained success
– Strategy and policy formulation
– Strategy and policy deployment
– Strategy and policy communication
– Financial resources
– Natural resources
– Improvement innovation and learning
Looking at the above additions it is evident that the overall policy of the organization has to expand beyond the broad policies that are commonly adopted under quality or environmental management systems.
The ISO 9004:2009 might be a good fit for your organization if you would prefer to pursue the excellence model within your organization.
At this point in time there is no certification for this standard, but you never know.