Customs and Health Canada

[Concat]

It becomes a medical device when the product is advertised as a way to quit smoking, or a nicotine delivery system. So Health Canada doesn't have to make the claim that ecigs are medical devices. A company does it themselves by making "health claims."

This is why you'll rarely see them advertised as a way to quit smoking, and in Canada, you'll never see them marketed as a way to deliver nicotine. It's simply implied.

The can't do anything, or rather, it's my understanding that they should not be doing anything, if an ecig is marketed as something as innocuous as a "novelty item." It's about intent. Without nicotine, the device is literally a small fog machine. Health Canada can't just claim fog machines are medical devices. It seems, however, they can do whatever they want now a days. There's no oversight.

 

[Cokeybill]

I was wondering why ejuice vendors use ejuice,vape, etc in their company's name. If a company was wise, they would go with something that does not attract customs to put up the "red flag" on a package coming into Canada. Sure on the info tag, there might not be any mention of the product(some vendors do this to pass "GO") but, the company name is a sure way of attracting customs. I have gottten my packages by requesting the vendor to put a personal name instead of company name on the return address. Anyone have an input on this possibilty for the vendors?
And as concerned about HC and their backdoor enhancements to manipulate bills and "Ninja" them in their "adjust to fit any circumstance"...ignorance on their part is our community's loss.

 

[Concat]

It's my opinion that people should only order internationally from companies recommended on here. If they don't, well then you're just accepting the risks.

HealthCabin, for example, uses a personal return address and on the customs form it said "Toy Gift."

 

[Cokeybill]

It's my opinion that people should only order internationally from companies recommended on here. If they don't, well then you're just accepting the risks.

HealthCabin, for example, uses a personal return address and on the customs form it said "Toy Gift."

GH1 gave me a "message therapy" form statement.

 

[Song]

The Therapeutic Products Directorate (TPD) of Health Canada is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use. Prior to being given market authorization, a manufacturer must submit substantive scientific evidence of a product's safety, efficacy and quality as required by the Food and Drugs Act and Regulations. .This is done through the filing of a drug submission to the TPD.
.
Here is some additional information to clarify the classification of electronic cigarettes under the Food and Drugs Act:

• a non-refillable disposable electronic smoking product (e.g., e-cigarette) prefilled with nicotine (or any other drug or Natural Health Product [NHP]) is considered to be a drug (or NHP)/medical device combination product and requires a DIN (or NPN). In this case, its drug delivery system is to be reviewed for safety and efficacy but a medical device license is not required;
• a refillable electronic smoking product (e.g., e-cigarette) with nicotine or intended to be used with nicotine (or any other drug or NHP) is considered to be a drug (or NHP) delivery system and, therefore, a Class II medical device, and its nicotine (or drug or NHP) component requires a DIN (or NPN). (Please note that no medical device licence is to be issued until the associated drug component has received a DIN [or NPN].);
• an electronic smoking product (e.g., e-cigarette) associated with a health claim but not associated with nor intended to be used with nicotine (nor any other drug nor NHP) is considered to be a Class I medical device.

What??? I really don't get this, didn't Happy Vaper get market autorization. But it shoudn't be classified as any of these 3 devices. All 3 of these classifications have health claim or nicotine in it. I don't think Happy Vaper has any health claims or nicotine no? My best bet would be number 3, a electronic smoking product associated with a health claim but not associated with nor intended to be used with nicotine. So we have to apply for a class 1 medical device even if we make zero health claims?

 

[Switched]

Happy Jack does have authorization.

 

[Song]

So basicly we need a class 1 medical device autorization even if we don't make any health claims?

 

[Switched]

In order not to sell the farm with my issue. I shut up, they sent it back, I got it back. Nuff said. Just don't read what's in the email hit the links. HC is down at the moment.

 

[kanadiankat]

So basicly we need a class 1 medical device autorization even if we don't make any health claims?

Only if you're willing to agree that an electronic cigarette is intended to be used to distribute medicine (apparently nicotine) - but that you do not intend to sell nicotine, recommend it, nor provide any information on it and make it clear to all your customers that they should not use your ecigs with nicotine.

If, on the other hand, you are selling electronic cigarettes as electronic cigarettes - then you should technically not need a medical device authorization - as electronics are managed / regulated mainly at a provincial level - but you will have issues from time to time with hardware and customs.

Have a look at the ECTA sticky thread - to get an idea of some of the ways this issue is being prepared for resolution.

 

[Song]

I just checked HC own page here something a little interesting:

2.0 Legislated Requirements

Any person who imports into Canada, or sells in Canada, a medical device for human use requires an establishment licence with the exception of

a retailer
a healthcare facility,
a manufacturer of Class II, III or IV medical devices that only sells:
medical devices for which they hold a valid licence, or
medical devices subject to Parts 2 and 3 of the Regulations,
a manufacturer of a Class 1 medical devices who imports or distributes solely through a licenced establishment,
a person solely selling medical devices subject to Parts 2 and 3 of the Regulations
a dispenser.


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Explanatory Notes

For manufacturers who are also involved in sales of other medical devices (for which they are not the manufacturer), the MDEL requirements are as follows:
If they are involved in any distribution activities, such as sales to healthcare facilities, they are acting as a distributor for these other medical devices and require a MDEL for these activities.
If they are solely selling these medical devices to consumers for their own use, and not for resale, the establishment is a retailer of these other medical devices and are exempt from the MDEL requirements.



So, we don't even need a MDEL if your only doing retail. By there own words lol. I'm so printing this and going to shove it in there face if they give me any problems at customs

 

[Concat]

And this will likely be their reply:

But if I'm not mistaken, you had nic juice in your order, no?

 

[Song]

Hey as long as i get my stuff, i couldn't care less about there excuses

 

[Switched]

as a supplier I wooda thunk you wooda already be on the up and up with this stuff?

 

[Song]

I'm a pretty new supplier Switched. Plus I think there new policy on stopping e-cigs without nic is pretty new. I also had other things to worry about at first, like finding good manufacturers with good quality e-cigs and not pieces of junks lol

 

[VIVAP2]

ok but what's next? isn't ECTA making a plan to look over these issues ?

 

[Switched]

ok but what's next? isn't ECTA making a plan to look over these issues ?

Yes they are but things are not going to happen overnight.

 

[Switched]

I'm a pretty new supplier Switched. Plus I think there new policy on stopping e-cigs without nic is pretty new. I also had other things to worry about at first, like finding good manufacturers with good quality e-cigs and not pieces of junks lol

I hear ya my good man. Yes the psoetd regs (advisory) have changed since original posting. I wish I had kept the old set as a text file so we can see the re-wording and additions.

Back when I started vaping hardware was a gray area, it seems the regs on that part have been firmed up. That is the impression that I got with my interactions with HC some months ago.

As stated elsewhere, when I started back in 2010, it was a known fact that we were under a ban, however, they really only targeted nic, which IMO led folks into a false sense of security. The rest of the world knows Canada is under a ban, how come we don't?

In my case 1 order over hundredths is a pretty good avg if you ask me That being said for new vapers getting dinged on their first or second really sucks.

 

[platinum]

"So, we don't even need a MDEL if your only doing retail. By there own words lol. I'm so printing this and going to shove it in there face if they give me any problems at customs "

Song I`m pretty sure you would still need an import licence and have a provincial/federal tax number.

 

[Ms. Creant]

I was wondering why ejuice vendors use ejuice,vape, etc in their company's name. If a company was wise, they would go with something that does not attract customs to put up the "red flag" on a package coming into Canada. Sure on the info tag, there might not be any mention of the product(some vendors do this to pass "GO") but, the company name is a sure way of attracting customs. I have gottten my packages by requesting the vendor to put a personal name instead of company name on the return address. Anyone have an input on this possibilty for the vendors?
And as concerned about HC and their backdoor enhancements to manipulate bills and "Ninja" them in their "adjust to fit any circumstance"...ignorance on their part is our community's loss.

Greenhouseone.com seems to have a firm grip on that concept, and apparently a lot of success getting packages through customs. They clearly state their guarantee to clear customs on their web site. Unfortunately, Canada and Germany are two that are not on the 'guaranteed' list but they take measures to increase success rate.

Edit: I was mistaken, the guarantee is in a post in their vendor forum, not on their website.

 

[Song]

Well I have a import number and provincial/federal tax number, just no licence for MDEL lol. I reread the rules, the wording I'm guessing it might be retailers are allowed to sale class 1 medical device with MDEL, but as soon as you start importing this stuff you become a importer and as such you need a MDEL or your manufacturer needs one. I'll check on it again.