Hi Anna. Thank you for your effort, I enjoyed your videos on medical devises , I would be thankful if you make a video on medical rep job in pharmaceutical and Biothec industry. Thank you so much .
Hi, do you have network who would like offer import agent services in Canada as a MDEL license holder? It’s so hard to fine them, which I don’t think it supposed to be.
Hi Anna, Thank you so much for the great work you've done . I'm curious to know if test strips such as urine ketone testing considered Medical device if yes than what class they should be under which I need to apply MDEL in order to import & sell? I hope to hear from you soon. Thank you.
Hi, thank you. All tests would be considered as in vitro diagnostic devices and they have a slightly different classification. I would suggest to check with Health Canada and you can also refer to my video here it shares some online resources : ruclips.net/video/DtzroPUowMM/видео.html&ab_channel=AnnaNesterova
Hi Anna, approx a year ago I began selling medical supplies online. I started doing small, regular sales to a couple healthcare facilities in my area of class 1 medical devices. I had never heard of an mdel until recently and Im pretty nervous having never obtained this license. Can you shed any light on what my options are, or what kind of consequences I might be facing?
Hi Anna, thanks for all the information that you provide to all the community. We are from Italy, where we develop medical device (Class 1) . We need now to adatp it to the Canada regulations, specially the electrical part, which is quite different to Europe. Where can get some company that help us to do that electrical adaptation and to register MDEL ? Is there any directory or could you advice where to look for them ? any advice will be appreciated ! thanks !
Ciao, yes, you will need to perform additional testing for either ISO or C-UL certification for Canada specific. CSA testing and certificate is also Canada and USA standard specific. There are third party organizations performing the testing. I can also arrange a consultation in this regard with someone who can guide you through the process, but it will have a consulting cost
Hi Anna I am looking to sell Derma Rollers which is a class 2 medical device. I am looking have them shipped from manufacturer in China and sold online on Amazon Canada. What do kind of licensing do I need to get or what do I need to sell these here. I look forward to your response
Hi Anna, thank you very much for the helpful information. I am a little confused, as I want to start importing medical devices, I understood that I need to apply for the MDEL as importer or distributer. However, does the manufacturer which is outside of Canada also need to apply for MDL? Thank you in advance!
I want to sell medical devices ,I am not creating or manufacturing .Do I need to have a certificate ,or is it enough that a class 2 is already legal and certified .
Hi, can you specify please, you want to sell a specific device that is class 2? Or you want to be hired by a company that makes class 2 medical devices?
Hi Anna, Thank you very much for very informative video. I am trying to import KF94 and FDA (USA) approved class 1 masks into Canada. Are these considered medical device, if so, are they considered a class I device which I need to apply MDEL in order to import & sell? It would be really great if you can let me know.. Thank you.
HI There, please watch my video here, as you need to double check the registration of this item in Canada. In 90% cases it is similar to US but 10% it can be different. Here is the link: ruclips.net/video/DtzroPUowMM/видео.html&ab_channel=AnnaNesterova
You can do it yourself on Health Canada website or hire a third party company that does it for a fee. Make sure the company is based in Canada and knows all the rules.
@@liveurlife-vv6lk you'd have to confirm the class first and yes, if they are I and II, you'd have to get both. You can find which class they belong on Health Canada website
Hi Anna, I am trying to import and sell a Blood Pressure Monitor from a manufacturer based in Asia. Can you please tell me if you have reference for a 3rd party agency that can help me and my manufacturer to fulfill the requirements of licensing and documentation?
@@ashishverma866 Hi Ashish, I do provide such services in partnership with another agency. You'd need to file for Class II MDL licence with Health Canada
@@AnnaNesterova So I need to file Class II MDL with Health Canada and the manufacturer has to register their device with HC also right? My manufacturer already has ISO 13485 quality system established and has CE CFDA certificate if that will help. I would like to take your services. How do we proceed from here?
@@AnnaNesterova Hi Anna, I am looking to import and sell derma roller (microneedling device - Class II) from China. Is getting a license something you can help me with? Feel free to email me.
@@uugegenyore9292 Yes, it is not a simple process. First of all, find what class of devices cosmetic lenses fall into. You can search competitive products that have active registration. I am actually working on the video on this topic.
@@uugegenyore9292 When you find what class, then you can go on the Health Canada website to get forms and you will know what information you will need from the manufacturer
Hi Anna, Great video, thank you! I am curious to know how to determine the class(1,2,3,4) for different products. Are there any resources for this to determine such?
Hi Azim, You'd have to follow the instructions on the Health Canada website, as they have full description of each class and exceptions. I usually guess based on my experience and then go to their website to double check. You can also email them if you have a specific product. Another way is to find out what class it is in the US or Europe and it means it will be similar in Canada. Hope it helps
Hi, Im starting to start my own business as a distributor, My manufacturing is from Pakistan and I shall distribute in Canada. Do I require a MDEL or do I need a MDL? OR BOTH? Thanks. 😇
Hey Ahsan. I'm going to setup import license here in Canada to import surgical instruments from Sialkot. Get in touch with me on osama.ak.283@gmail.com
Thanks for touching this aspect. Useful to know about 6 category you mentioned
I have subscribed and hit the bell button. Thank you so much for this video, Anna.
Fantastic content and amazing audio. Which microphone did you use for the video ?
Hi Anna. Thank you for your effort, I enjoyed your videos on medical devises , I would be thankful if you make a video on medical rep job in pharmaceutical and Biothec industry.
Thank you so much .
Hi Anna, How do I get a license number for my company? So I can register my device.
you said, we may not need license if importing from a licensed company. wondering would i still need a license if its in other country? and licensed
hi there, a manufacturer has to have license to sell in Canada, depending on class of the device. are you a local importer/distributor in Canada?
Hi Anna thank you I am Justin bio medical engineer my experience 14 year
Hi, do you have network who would like offer import agent services in Canada as a MDEL license holder? It’s so hard to fine them, which I don’t think it supposed to be.
I really appreciate it. Thanks.
Hi Anna, Thank you so much for the great work you've done . I'm curious to know if test strips such as urine ketone testing considered Medical device if yes than what class they should be under which I need to apply MDEL in order to import & sell? I hope to hear from you soon. Thank you.
Hi, thank you. All tests would be considered as in vitro diagnostic devices and they have a slightly different classification. I would suggest to check with Health Canada and you can also refer to my video here it shares some online resources : ruclips.net/video/DtzroPUowMM/видео.html&ab_channel=AnnaNesterova
@@AnnaNesterova Thank you so much
Hi Anna, approx a year ago I began selling medical supplies online. I started doing small, regular sales to a couple healthcare facilities in my area of class 1 medical devices. I had never heard of an mdel until recently and Im pretty nervous having never obtained this license. Can you shed any light on what my options are, or what kind of consequences I might be facing?
want to be hired by a company that makes class 2 medical devices?
Hi Anna, thanks for all the information that you provide to all the community. We are from Italy, where we develop medical device (Class 1) . We need now to adatp it to the Canada regulations, specially the electrical part, which is quite different to Europe. Where can get some company that help us to do that electrical adaptation and to register MDEL ? Is there any directory or could you advice where to look for them ? any advice will be appreciated ! thanks !
Ciao, yes, you will need to perform additional testing for either ISO or C-UL certification for Canada specific. CSA testing and certificate is also Canada and USA standard specific. There are third party organizations performing the testing. I can also arrange a consultation in this regard with someone who can guide you through the process, but it will have a consulting cost
An anyone helpe to get medical class 2 license in Ontario
Thank you so much. Do you have a video on how to write the handling procedure handbook? Or do you know an a creditable service that does so?
I am sure there are special firms that are doing it, but I do not know one
Are surgical face masks, n95 masks, and hand sanitizer considered class 1?
yes
Hi, can you tell me which class do 0.50mm derma roller fall under?
Hi Anna , I am trying to import skin suture for practice purpose only so what do I need?
probably nothing if it is not for commercial use or use on patients
Great video. Very useful.
Glad it was helpful!
Hi Anna, how can i contact you for licencing process ?
you can fill out the form or use the email address on the website www.avamedical.ca
Hi Anna I am looking to sell Derma Rollers which is a class 2 medical device. I am looking have them shipped from manufacturer in China and sold online on Amazon Canada. What do kind of licensing do I need to get or what do I need to sell these here. I look forward to your response
Hi Anna, thank you very much for the helpful information. I am a little confused, as I want to start importing medical devices, I understood that I need to apply for the MDEL as importer or distributer. However, does the manufacturer which is outside of Canada also need to apply for MDL? Thank you in advance!
Yes if you belong to class 2 3 4
You have to get mdl as a manufacturer after getting mdsap
I want to sell medical devices ,I am not creating or manufacturing .Do I need to have a certificate ,or is it enough that a class 2 is already legal and certified .
Hi, can you specify please, you want to sell a specific device that is class 2? Or you want to be hired by a company that makes class 2 medical devices?
Would like to get job opportunities Laparoscopy surgical instruments suppliers as store keeper in gulf countries
Hi Anna, Thank you very much for very informative video. I am trying to import KF94 and FDA (USA) approved class 1 masks into Canada. Are these considered medical device, if so, are they considered a class I device which I need to apply MDEL in order to import & sell? It would be really great if you can let me know.. Thank you.
HI There, please watch my video here, as you need to double check the registration of this item in Canada. In 90% cases it is similar to US but 10% it can be different. Here is the link: ruclips.net/video/DtzroPUowMM/видео.html&ab_channel=AnnaNesterova
Iits interesting, I need to fill up MDEL form class-1 who can help me please
You can do it yourself on Health Canada website or hire a third party company that does it for a fee. Make sure the company is based in Canada and knows all the rules.
Prescription glasses and lens and frame are in which class? Thanks in advance
glasses class i but lenses most likely II
@@AnnaNesterova thanks... So I have to get these two licensed seperately.
@@liveurlife-vv6lk you'd have to confirm the class first and yes, if they are I and II, you'd have to get both. You can find which class they belong on Health Canada website
@@AnnaNesterova thanks
Hi Anna, I am trying to import and sell a Blood Pressure Monitor from a manufacturer based in Asia. Can you please tell me if you have reference for a 3rd party agency that can help me and my manufacturer to fulfill the requirements of licensing and documentation?
I know BP monitors are class II device
@@ashishverma866 Hi Ashish, I do provide such services in partnership with another agency. You'd need to file for Class II MDL licence with Health Canada
@@AnnaNesterova So I need to file Class II MDL with Health Canada and the manufacturer has to register their device with HC also right? My manufacturer already has ISO 13485 quality system established and has CE CFDA certificate if that will help. I would like to take your services. How do we proceed from here?
@@ashishverma866 I will reply in the email
@@AnnaNesterova Hi Anna, I am looking to import and sell derma roller (microneedling device - Class II) from China. Is getting a license something you can help me with? Feel free to email me.
Hi Anna, am looking to order some cosmetic contact lenses, would I be needing any certification from the manufacturer
hi, are you ordering for personal use or you are planning to import?
Planning to import and I find it difficult to fill the right forms I have the companies medical device certificate send to me but not sure what to do
@@uugegenyore9292 Yes, it is not a simple process. First of all, find what class of devices cosmetic lenses fall into. You can search competitive products that have active registration. I am actually working on the video on this topic.
@@uugegenyore9292 When you find what class, then you can go on the Health Canada website to get forms and you will know what information you will need from the manufacturer
@@AnnaNesterova it is under class two but filling the form is abit difficult and I do not want to make any mistakes
Hi Anna,
Great video, thank you! I am curious to know how to determine the class(1,2,3,4) for different products. Are there any resources for this to determine such?
Hi Azim,
You'd have to follow the instructions on the Health Canada website, as they have full description of each class and exceptions. I usually guess based on my experience and then go to their website to double check. You can also email them if you have a specific product. Another way is to find out what class it is in the US or Europe and it means it will be similar in Canada. Hope it helps
Hi, Im starting to start my own business as a distributor, My manufacturing is from Pakistan and I shall distribute in Canada. Do I require a MDEL or do I need a MDL? OR BOTH? Thanks. 😇
Hi, it depends on the class fo your products
@@AnnaNesterova ☠☠
Hey Ahsan. I'm going to setup import license here in Canada to import surgical instruments from Sialkot. Get in touch with me on osama.ak.283@gmail.com
@@osamaahmedkhan7526 Ok Inshallah.
@@osamaahmedkhan7526 AM LOOKING TO GET START A CONTANT LENSE BUSINESS WONDERING THE PROCESS TO GET MDEL
😁🙂👍🏼❤
Hi Dear I want to import dental materials how to make licence for small business
please feel free to message me with your response thank you