ANVISA (The Brazil National Health Surveillance Agency) issued the rule IN 4 on September 24, 2015  (that superseded the IN 11, dated December 16, 2014) which requires the standard ABNT NBR IEC 60601-1:2010 + Emenda IEC:2012 – the Portuguese translation of IEC 60601-1:2005 + Amendment 1:2012 (Edition 3.1 or 3rd edition + Amendment 1).  This standard is required for any new product seeking ANVISA approval since September 24, 2015 and going forward.

Before we get to the 60601-1-9 issue let’s talk a little about which version of 60601-1 applies.  If you have an INMETRO certificate that met 60601-1 3rd ed. you are ok until you have to rectify your product or your certificate expires.  If the Particular Standard 60601-2-XX  is still based on the 2nd ed. of 60601-1 then you still can use the 2nd edition of 60601-1.  But check the IN 4 before you move forward that way to make sure you are using the proper version of the applicable standards.  For the EMC standard you only need to deal with the 60601-1-2 3rd ed. which is equivalent to the 2007 edition of IEC 60601-1-2 and is the less stringent standard compared to 4th ed of 60601-1-2.

Along with 60601-1 there were a long list of other 60601 based standards in the Notice including the 60601-1-9 standard for “environmentally conscious design of medical electrical equipment”.  If you would like a copy of this notice please e-mail me at Leo@EisnerSafety.com.  I believe that Brazil is the first country that is mandating the use of 60601-1-9 . The full IEC standard title is “IEC 60601-1-9:2007 + Amendment 1:2013 Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design“.  The Brazilian version of the standard is ABNT NBR IEC 60601-1-9:2014 which is translated into Portuguese and the text is identical to IEC 60601-1-9:2007 + A1:2013.

ANVISA is requiring compliance to the standard by December 1, 2016 specifically for the clauses 4.1, 4.5.2 and 4.5.3 of the standard.  So, the documentation needed will include the identification of environmental aspects (clause 4.1), instructions for minimizing environmental impact during normal use (clause 4.5.2), and information for end of life management (clause 4.5.3). 

If you need help with IEC 60601-1, any in the Series of Standards or any National Version of these standards please email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants.

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.

You don’t have to leave your office to join in on the presentation and as a special thank you for visiting us at Eisner Safety Consultants you can get a 20% discount.  To find out more about the presentation & discount just click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

We have decided to send out a monthly update of our blog posts for each month which are all located at www.EisnerSafety.com/Industry_News/.  We have been working out the bugs for the last few weeks and we are ready to go live as of today, 31 July 2012 evening (Some may receive your copy on 1 August).  If you haven’t viewed our blog posts in the last several months there have been some significant posts covering a lot of issues around national implementation of IEC 60601-1, 3rd edition (Japan, article on US, Canada, EU & Brazil) and Amendment 1 (just released); EU Competent Authorities formed Central Management Committee (CMC) for medical device sector & Issued Four Decisions; and much more.  You can also view our posts on Twitter at our Twitter feed at http://Twitter,com/EisnerSafety/.

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