Rob Packard, a Quality System & Regulatory expert of Medical Device Academy, was gracious enough to allow us to post these articles he wrote recently on Canadian Medical Device Regulations.  Thx Rob!

The first article is a hypothetical case study that explains the process of obtaining a Health Canada Medical Device License.

The second and third articles are a 2 Part Series on the 11 Steps to Obtaining CMDCAS Certification.

• Part 1 focuses on the process of verifying the classification, selecting a registrar and obtaining a quote for CMDCAS certification. 
• Part 2 focuses on the process of updating the quality system (Licensing, Mandatory Problem Reporting, & Recall Procedures), finding a distributor, training your staff that touches parts of the quality system that are impacted by the CMDR, conducting internal auditing to applicable sections of the CMDR, going thru the CMDCAS certification audit, and lastly if applicable your Submission of your License Application. 

First a closing statement press release from the GHTF president was issued recently (dated Nov 2012) and on the International Medical Device Regulators Forum (IMDRF) webpage for the Archived GHTF documents there is a statement at the top of that page stating:

• “Important! The organisation GHTF no longer exists, and has been permanently replaced by the IMDRF. All material appearing on this page and the pages within has been moved here from the old GHTF site for preservation, and is no longer current. It is historic information and should not be acted upon.”

Another point to note is that the last set of documents from the GHTF were issued on 2 Nov 2012 and the IMDRF website in the last couple days seems to have been totally updated and reorganized in an easy to use format that will make it easy for the public to view this valuable resource and to stay up to date on the happenings of this organization.   Hopefully,  in the next decade, or sooner, the IMDRF will begin the process of Harmonizing areas of the international medical device regulatory arena so medical device manufacturers won’t have to deal with varying regulations through out the world.

On the Archived GHTF webpage it also states that they have brought all of the current and archived GHTF documents over to the IMDRF website.  Note, that the GHTF website is still up but it is not clear what will happen to it or when it will be taken down.

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More about the IMDRF: Straight from the IMDRF website the following gives you some information about the organization.  If you have furhter questions about the organization please contact the IMDRF secretariat at imdrf.secretariat@tga.gov.au

IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.

IMDRF was born in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum. A copy of the outcome statement from this meeting is available from the Meetings page.

Further information about the work and operations of IMDRF is available in its Terms of Reference (Note, the last page of this document has an organizational chart showing the roles and inte-relations of these roles).

On the About Us webpage  they go on to describe the different roles and responsibilities within the IMDRF.   The functions described are the IMDRF Management Committee; the Management Committee Members (Australia, Brazil, Canada, Europe (the EU), Japan, and the USA);  Official Observers (World Health Organization {WHO}); Affiliate Organizations; and Working Groups.

RAPS Regulatory Focus Article posted 30 Oct 2013 on the subject is interesting and provides some additional background and perspective.

Enjoy the article!

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:

1. 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.
2. 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.
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.”

The following text has been taken straight from the Health Canada website on the page for this final guidance document

“A draft version of this guidance document was first published and released for consultation in 2006. Comments from stakeholders and the Scientific Advisory Panel on Reprocessing of Medical Devices have been considered in producing this final version.

To reduce the risks associated with the use of reprocessed reusable medical devices, Health Canada has developed this guidance document to aid manufacturers of Class I, II, III and IV reusable medical devices in the preparation of reprocessing and sterilization information to be provided with these devices.

The guidance document is intended to assist manufacturers in understanding and complying with the regulatory requirements of section 21(1)(i) of the Medical Devices Regulations as they pertain to the directions for use for reusable medical devices. This guidance document should be used in conjunction with the Guidance Document on Recognition and Use of Standards under the Medical Devices Regulations.

In order to provide industry with sufficient time to meet the specifications of the guidance document, Health Canada will allow a six-month transition period commencing on the date of implementation, June 1, 2011. Following the transition period, Health Canada will expect manufacturers to meet the specifications listed in the guidance document.

Further information on this guidance document, and a summary of comments received and Health Canada’s responses to them, may be obtained by contacting:

Device Evaluation Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Phone: 613-954-0297
Fax: 613-957-9969
E-mail: DED_manager@hc-sc.gc.ca

Published by authority of the Minister of Health

Date Adopted 2011/06/01

Effective Date 2011/06/01

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.”

Per the Interpretation issued  e-labelling refers to the information required by section 21(1) of the Regulations (Medical Devices Regulations – SOR/98-282) that would ordinarily be found in the directions for use. Per the notice:

“The directions for use may include a surgeon’s instruction manual, operator’s manual, or user’s manual. At this time, the only acceptable electronic media in which to present information to satisfy the labeling requirements of section 21(2) of the Regulations are those described below.

Electronic labelling may be provided on Compact Disc (CD) or Digital Video Disc (DVD), accompanying the device at the time of sale and/or delivery….The CD/DVD must be packaged with or accompany the device in a manner that alerts the user to its purpose. The information provided on CD/DVD should be easily navigable.

For the following two categories of devices…, this information may, in the alternative, be provided in downloadable format from the internet: Class IV medical devices and in vitro diagnostic devices (IVDDs) that do not fall within the definition of near patient IVDD. The internet address must accompany these devices at the time of sale and/or delivery, and be displayed in a manner that alerts the user to its purpose…

Manufacturers should ensure that the labelling information provided in electronic format is identical in content to the paper format submitted with the device licence application…

Upon request, a paper copy of the label information should be provided promptly to the user, without additional cost.

Since this Notice is permissive in nature, it is effective immediately….”

For full text of the notice click here or go to the Health Canada webpage for this notice.