Changes in NRTL Mark affect Regulatory Approvals?

T

TaraMedical

#1
Hello -

I've heard that even if a company makes an unrelated label change, it could affect their device approval in some countries.

I understand that the NRTL mark is only for US certification under OSHA. However, if a company changes the NRTL mark on their label, with no changes to construction or certification results, will that company need to resubmit their device for approval in certain countries?

Thanks!

-Tara
 
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M

MIREGMGR

#2
AFAIK, only Canada shares use of NRTL-issued certification marks with the US.

However, in case I'm forgetting something...what countries are of concern? What standard(s) are the subject of the certification mark(s)?
 
T

TaraMedical

#3
Thanks for the question. The standard could be UL 60601 or UL 61010. I can't think of other standards that would result in NRTL marks for regulated medical or IVD devices that need regulatory approval before they can be sold.

To clarify, if a manufacturer changes the look of a label (i.e. the NRTL mark), then would the manufacturer need to resubmit the technical file to the regulatory body for re-approval based on label change alone?

For manufacturers selling globally, the applicable regulatory bodies could be ANVISA (Brazil), JMDR, KFDA (Korea), TFDA (Taiwan), SFDA (China), Health, TGA, (Australia), Health Canada, Roszdravnadzor (Russia), etc.

I guess the other part of this question is understanding whether a change in the look of a label is likely to hold a product up in customs and in which countries?
 
M

MIREGMGR

#4
My company has several thousand products, labeled with our or our private label/contract customers' identifications, in global distribution. Periodically we revise the layout or other formatting aspects of some of these labels.

Our experience has been that device regulators care about label content, not format or "look". We've never had pushback on a label format/"look" change from any country where we or our customers do business.
 
D

drewsky1

#5
We are removing the NTRL symbol from our electrical devices and will not obtain the specific service contract required to put the symbol on the label. Our devices have completed and passed all IEC60601-1 testing and have CB test reports. We have been told this is a major issue in Canada and that Canada must bear an approved electrical safety certification mark, as required under the Canadian Electrical Code and each provincial Electrical Safety Code. Has anyone had experience with this? We are aware of other medical device companies that do not have the NTRL symbol and they are selling product in Canada. We researched this prior to our decision. We do realize that there may be a problem at Customs that may question no NTRL symbol on product but if we provide the CB test report there would be no problem. We also will continue to put on the label that the product complies with the CSA standard. Any feedback would be appreciated. :confused:
 
M

MIREGMGR

#6
Medical devices that are mains-connected to obtain electrical energy to operate are subject to two kinds of regulation; as medical devices, and as electrical equipment. An NRTL mark may indicate that a device has been reviewed by the issuing party for conformance to a standard (such as a national version of IEC 60601-1) that is relevant to medical device regulation, but if such an NRTL mark is present it always indicates that the device is designed and manufactured to conform to electrical safety requirements.

For devices that must be hardwired at installation, it's common for the local electrical inspector (the point-person in electrical code enforcement) to require that the installed equipment have an NRTL mark, as locally adopted (in the US) or provincially adopted (in Canada) codes almost always want.

For devices that plug-connect, hospitals' insurance companies often mandate that such equipment have an NRTL mark.

Because of these factors, hospital purchasing agents, installation electricians, engineers, biomed techs and others involved in the qualifying/buying/installing process may have a problem with systems that are not NRTL marked. Some hospitals have rules requiring such marking.

The challenge in discontinuing NRTL marking for mains-connected medical devices thus is a marketing one: can you convince customers to buy it, given that there potentially are multiple ways that their lives could be made more difficult during the process of getting it installed and into use?
 
D

drewsky1

#7
Thank you Miregmgr. Your comments validate our research on the risk of removing the NTRL mark. However, we are being told it is a regulatory issue whereas it is a requirement to have the NTRL mark on the device labeling in order to register the product in Canada. This is what we find puzzling.
 

Peter Selvey

Staff member
Super Moderator
#8
The NRTL mark is purely a US issue, it does not have any legal meaning in Canada.

What you are probably talking about is what is called an SCC mark, since it is administered by the Standards Council of Canada.

Most agencies offer a certification mark which consists of their company logo (e.g. UL, CSA, ETL, TUV etc) but with some small addition to indicate if the certificate is NRTL, SCC or both. Most manufacturers choose both, as it does not cost much more to cover both at the same time. But for Canada, the NRTL side has no meaning, only the SCC part.

In Canada, for the medical device regulations you do not need an SCC mark.

However, state law covering electrical safety can refer to the Canadian Electrical Code (CEC) which in turn requires approvals (via SCC mark), with a list of product standards given in Annex A.

For example in British Columbia, B.C. Reg. 100/2004 "Safety Standards Act ELECTRICAL SAFETY REGULATION", Section 20 says that
The Canadian Electrical Code, Part I, Twenty-first Edition, Safety Standard for Electrical Installations, Canadian Standards Association Standard C22.1-09 is adopted in whole.
I only have the 2007 edition of the CEC which is out of date, but it says:
2-024 Use of approved equipment (see Appendix A)
Electrical equipment used in electrical installations within the jurisdiction of the inspection department shall be approved and shall be of a kind or type and rating approved for the specific purpose for which it is to be employed.
Appendix A then lists CAN/CSA-C22.2 No. 601.1-M90.

I remember reading something that the CEC is being updated to refer to CSA's version of IEC 60601-1:2005 (the 3rd edition), but I need to check on that. If someone has the information on hand, it would be useful to add here.
 
D

drewsky1

#9
This is a good clarification, however per Health Canada below it appears the labeling requires a "mark of conformity" an acceptable Canadian certification organizatio. So even if we have a CB Certificate stating we comply to CAN/CSA-C22/2 No. 60601-1 , we still need to include this "mark" on our labeling which does not go without it's cost.

A Medical Device Licence is issued by Health Canada when acceptable evidence has been provided to show that the device meets the requirements of the Medical Devices Regulations. However, manufacturers are reminded that the Canadian Electrical Code is separate and distinct from the Medical Devices Regulations and is mandated by Provincial and Territorial electrical safety authorities, not by Health Canada. Therefore, in addition to having a medical device licence, mains-powered electromedical devices sold in Canada must be "approved" under the Canadian Electrical Code, and must bear a mark of conformity recognised by the Provincial and Territorial electrical safety authorities. For further information regarding these requirements, contact the applicable regulatory authorities
 

Peter Selvey

Staff member
Super Moderator
#10
Yes, Health Canada is saying the same thing, the state or provincial regulation refers to the CEC, the CEC requires the approval and also refers to the SCC operated scheme for the approval, which then UL, CSA, ETL, TUVs etc all use to issue an SCC Mark (which looks similar to an NRTL mark).

Keep in mind the SCC mark (and the NRTL mark) is more than just the testing phase. It includes ongoing factory inspections for regular production, obligations for the manufacturer to report design changes. Most significantly, the agency that issues the mark takes part of the responsibility for the basic safety of your product. The costs money, but I think it's reasonable and worth it for basic safety. I'm sure without the NRTL, SCC and similar schemes there would be far more electrical safety incidents than occur now.

A CB certificate is really just a test report on the sample tested. That's all.
 
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