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Health Canada medical device licences, apostilled for your COFEPRIS file

Your Mexican distributor needs the Canadian licence “debidamente legalizado”, and the guides you find online still describe a consular step that no longer exists. We take the licence PDFs exactly as Health Canada issued them, have each one apostilled for Mexico, and deliver the originals to your registration holder by DHL Express, with scans and verifiable apostille numbers the day they are issued. Nothing to ship from your side of the world.

Get a fixed quote Compare the two routes
Authority
Global Affairs Canada
Health Canada licences are federal
Government fee
None
The federal apostille is free
Federal queue
About 25 business days
No paid rush exists
Delivered to
Your distributor in Mexico
DHL Express, signature on delivery
What changed in 2024

An apostille, not a Mexican consulate stamp

Until January 11, 2024, a Canadian document bound for Mexico needed two steps: authentication by Global Affairs Canada, then legalization at a Mexican consulate. On that date Canada joined the Hague Apostille Convention, which Mexico has applied for decades, and the consular step disappeared. The Consulate General of Mexico in Toronto says so on its own website, and Mexican consulates in Canada now decline to legalize Canadian documents.

That matters because many regulatory guides, distributor checklists and even competitor pages were written before 2024. If your distributor asks for “legalización consular”, the answer is the apostille: it is the only form of authentication available for a Canadian document today.

COFEPRIS asks for foreign legal documents to be “debidamente legalizados”, and its own guidance defines the accepted forms: the apostille for Hague Convention countries, consular legalization only for countries outside the Convention. Canada is now in the first group.

Each apostille carries a certificate number that anyone can check in Global Affairs Canada’s public online register. We send those numbers with the scans, so your distributor’s submission includes independent proof of authenticity, which is stronger than a consular stamp ever was.

Two routes

Standard or express: which one your file can use

Both give you a valid apostille under the Hague Convention. The difference is what the apostille sits on, and how long the queue is.

Standard: the licence itself

  • The apostille is placed directly on the Health Canada licence, by Global Affairs Canada in Ottawa.
  • We work from the electronically issued licence: no paper request to Health Canada, no notary.
  • Current federal queue: about 25 business days, plus 5 to 10 business days of mail each way.
  • The safe choice for COFEPRIS, and the one we recommend unless your timeline is tight.

Express: a notarized copy, apostilled in Toronto

  • A Canadian notary certifies official copies of the licences, and Ontario apostilles them in person, usually within 2 business days.
  • About 1 to 2 weeks door to door, delivery to Mexico included.
  • The apostille certifies the notary’s certified copy, not the licence itself.
  • Confirm with your distributor that COFEPRIS accepts an apostilled notarized copy for your submission before choosing it.
Do you need a certificate of free sale? Often not. Under Mexico’s abbreviated regulatory pathway for devices already authorized in Canada, the licence itself is the central document. Health Canada’s export certificate is signed electronically and cannot be apostilled as sent; read our guide to the certificate of free sale before ordering one.
Built for regulatory teams

What we handle, so your RA team does not have to

  • Nothing to ship from abroad. Send the licence PDFs by email; we prepare the submission in Canada.
  • Checked before filing. Each licence is verified against Health Canada’s Medical Devices Active Licence Listing, so an expired or amended licence is caught before it costs you weeks.
  • Tracked filing and follow-up until every apostille is issued.
  • Scans the same day, in colour, with the apostille numbers, so your distributor can prepare the submission before the originals land.
  • DHL Express to your registration holder in Mexico, signature on delivery, with a delivery guarantee: if the envelope is lost, we obtain new apostilles and ship again at no charge.
  • Quoted and invoiced in US dollars, to the manufacturer or the Canadian licence holder, payable by bank transfer or corporate card.
  • One fixed price per submission, with additional licences in the same submission at a reduced per-document rate.
  • One contact who answers your distributor’s questions directly if COFEPRIS raises any, with you in copy.
Common questions
Can a Health Canada medical device licence be apostilled?
Yes. Medical device licences are federal documents, so Global Affairs Canada apostilles them directly, and in our experience it authenticates the electronically issued licence as long as it shows the signing official’s name and signature, which current licences do. No notarization is needed on the standard route.
Does Mexico still require legalization at a Mexican consulate?
No. Since Canada joined the Hague Apostille Convention on January 11, 2024, the apostille is the only authentication required for a Canadian public document in Mexico, and Mexican consulates in Canada no longer legalize Canadian documents.
How long does the apostille take?
On the standard route, the federal queue is currently about 25 business days, plus 5 to 10 business days of mail each way, then 3 to 5 days by DHL Express to Mexico. Plan on about 6 to 8 weeks from filing to delivery. The express route, through a notarized copy apostilled in Toronto, takes about 1 to 2 weeks, if the receiving authority accepts it.
Do the originals have to come from Korea, Europe or the United States?
No. We work from the licence PDFs issued by Health Canada and prepare the submission in Canada, so nothing irreplaceable is put in the mail on your side.
Does the licence need a Spanish translation?
That depends on your registration holder and on the submission. When a translation is required in Mexico, it must usually be done by a perito traductor recognized there, and a translation made in Canada would not be accepted. Ask your distributor before the file starts; we can coordinate one in Mexico if needed.
Can you issue the invoice to our Canadian licence holder or to the manufacturer?
Either. Tell us which entity should be invoiced, and whether you pay by bank transfer in US dollars or by corporate card. Nothing is payable before the submission is ready to file.
5.0 on Google
“I highly recommend this agency. They keep you informed every step of the way, providing accurate and reliable information…”
David Alvarez-Carbonell, Google review
“Great team and excellent coordination; I received my apostille in less than 6 days, just in time for my trip. Best of luck to the whole team!”
Ludy_Daan, Google review
“I highly recommend Viapostille. Their team was professional, attentive…”
Ghassan Nasri, Google review

Send us the licence PDFs and the delivery address in Mexico

We confirm the route, check each licence against Health Canada’s active listing and send a fixed all-in quote within one business day, with delivery to your distributor included. Nothing is payable until we file.

Get a fixed quote