Export Of Approved Canadian Medical Devices - What export certs are needed

[OCCUL - 2007]

Looking for information on what export certs are needed to export approved medical devices to foreign countries. On the Health Canada site -I can only find the "Application for Pharmaceutical Export Certs Required by Foreign Countries" and nothing for medical devices.. Have attempted to contact them several times..
Thanks in advance for any assistance

 

[Pataha]

O.K. for imprting to Canada do you have a distributor or agent? If so are the registered with Health Canada? What Class is your device? Is it electronic?

You will need to be registered ISO 13485:CMDCAS. They have a list of many auditing groups. However, when I did a reference check on the many that are allowed, the only one that did not have negative things said about them - in speed and ease to work with, was QMI. If you do not have one. I can provide a telephone number for a contact if need be.
For some guidance from Health Canada go to

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down side is that is still talks about ISO13485:1996. Health Canda gives you till 16 March 2006 to change over to ISO 13485:2003.
For the active license direction call 613-957-1426 that is the telephone to the reviewers and they should direct you. Maurice at 613-954-4587 is also very informative about requirements for Health Canada, almost everyone I speak with refers me to him and then he will direct me to others.
If you have questions about the ISO 13485:CMDCAS your Health Canada person would be Eagan Cobbold at 613-954-4597. I have had positive expereinces in dealing with all of the people.

For AU, you will need an in country agent when dealing with the TGA. However, the info is easy to read and follow. The only bummer is they are moving away from accepting 510(k)s and want the CE mark.
Europa follow the essential requirments of your notifing body. If you choose QMI for your certification audits, they work with DGM for CE marking in Europe.

One of the many Craigs on the forum

 

[OCCUL - 2007]

Export from Canada to foreign countries

Thanks...

I am looking for instructions on how to export class II approved/licenced medical devices in canada to foreign countries. In other words, we have 13485/medical device licence/establishment licence for products in Canada...just want to know what certs are necessary for export (from Canada) to foreign countries.....

Thanks

 

[Pataha]

Does this mean that you already have a CE Mark for Europa?

If you have met the regualtory requirments for the countries you are exporting to (for the U.S. you will need a 510(k)).

The documents are fairly easy. You will need a "Commerical Invoice for Customs"
It is what you would expect on any invoice. However, a statment may be needed to either avoid or pay reduced tarrifs.

For AU, we do something like:

"Certificate of Origin on File"
(Medical Equipment Enclosed)
Product Manufactured in the USA"
"Note: with reference to "The USA/Australia Free Trade Agreement", this is to confirm that the goods shipped to ABC Ltd are a 100% manufacture of USA and are eligible for preferential Duty Rate."

I do not if this will help, but I would suggest contacting the government. The following is some Email addresses that should get you started.
Good Hunting.

International Trade Canada (ITCan)
https://www.itcan-cican.gc.ca


Canadian Trade Commissioner Service
https://www.infoexport.gc.ca/


Investment Partnerships Canada
https://www.investincanada.gc.ca


Team Canada
https://www.tcm-mec.gc.ca/


Trade Negotiations and Agreements
(broken link removed)