Between mid-August and mid-October 2026, regulators in Canada, Mexico, Colombia, Chile and Argentina published rules or guidance that a device maker selling there should act on. Taken one market at a time, most of it looks minor. Taken together, it points one way: most of the new work falls on whoever imports your product or holds your registration in the country, not on you. So the place to deal with it is your distribution agreement, and you need to do it before the dates below.
Chile is the exception. It is opening a regulated market on a fixed timetable, and companies that are ready early will have an advantage.
Every date in this piece is either printed in the instrument or worked out from the rule the instrument sets. Where we had to count the days ourselves, we say so. All instruments were read on 19 October 2026.
The calendar
| Date | Market | What happens | Where the date comes from |
|---|---|---|---|
| 1 Sep 2026 | Argentina | ANMAT's revised fee schedule takes effect, with a new cap on the fee for each device import | Printed in Disposición 5461/2026, art. 3 |
| 2 Sep 2026 | Canada | New web forms for exceptional importation during shortages. Notice before a shipment arrives falls from 5 to 3 business days | Health Canada notice, 2 Sep 2026 |
| 7 Sep 2026 | Colombia | Resolución 1763 (the SISCAATS supply-reporting system) takes effect on publication. Device reporting is not live yet | Publication date in the Ministry's own list of instruments |
| 7 Oct 2026 | Argentina | New process for ANMAT good-manufacturing-practice certificates for factories outside Mercosur, based on ISO 13485 | Disposición 6403/2026: in force the day after publication on 6 Oct |
| 1 Dec 2026 | Canada | Establishment-licence changes take effect: holders must give supplier lists, and foreign distributors no longer need a licence | Our count: the regulation says the 180th day after registration on 4 Jun 2026. Health Canada's own bulletin says 14 Dec. See below |
| 1 Feb 2027 | Canada | Special Access Program requests for devices are accepted only on the new form, sent by the routes set out in the notice | Printed in Health Canada's notice of 24 Aug 2026 |
| By 7 Mar 2027 | Colombia | The Ministry's own deadline to switch on device reporting in SISCAATS. Reporting becomes mandatory two months after that | Our count: six months from publication, which the resolution sets as a maximum |
| By 19 Mar 2027 | Chile | ISP's technical instructions for the 39 newly regulated device categories are due. Voluntary registration opens once they are issued | Our count: 12 months from the decree's publication on 19 Mar 2026 |
| 14 May 2027 | Mexico | NOM-137-SSA1-2025, the new device labelling standard, takes effect. It includes rules for identifying software | Our count: the NOM says 360 calendar days after publication on 19 May 2026 |
| 17 Jun 2027 | Canada | Amended shortage and discontinuation reporting for devices takes effect | Printed in GUI-0137 v4. It is the first anniversary of the regulation's publication |
| 10 Nov 2027 | Mexico | End of the 180-day period to use up stock labelled under the old standard | Our count from the NOM's transitory article |
| Mar 2028 / Mar 2029 | Chile | Registration becomes mandatory for 13 categories after 24 months, and for the other 26 after 36 months | The decree's own timetable, counted from 19 Mar 2026 |
The cross-market point: a company registered in several of these markets is running several calendars at once, and different local partners are responsible for each. As at 19 October 2026, 1,469 manufacturers in our corpus have registrations on record in both Canada and Colombia, so two of the rows above can apply to each of them.
Canada: your importer's licence changes on 1 December
What changed. The Regulations Amending the Medical Devices Regulations (Establishment Licences), SOR/2026-110, were registered on 4 June 2026 and published in the Canada Gazette, Part II on 17 June 2026. They make three changes to the medical device establishment licence (MDEL) regime:
- Foreign distributors no longer need an MDEL when they sell to a Canadian importer that holds one. Hospitals and retailers that import without a licence must still buy from a licensed supplier.
- Every MDEL applicant must list its suppliers: the name and address of each person, other than the manufacturer, who sells it devices for import or distribution, and the classes of device each one supplies. Holders update the list at the annual licence review.
- The attestation about documented procedures is gone. In its place come explicit duties to keep documented procedures, assigned by role. Manufacturers, importers and distributors must each have procedures for distribution records, and for Class II to IV devices for handling, storage, delivery, installation, servicing and corrective action. Manufacturers and importers must have procedures for incident reports. Licence holders and importers of Class II to IV devices must have procedures for supplying serious-risk information.
When. Section 10 of the regulation says it comes into force "on the 180th day after the day on which they are registered". It was registered on 4 June 2026, which by our count makes the date 1 December 2026. Health Canada's compliance bulletin of 17 June gives 14 December 2026, counting 180 days from the Gazette publication instead. The regulation's own text is what binds, so plan for 1 December. Under the transitional provision, an application still undecided on that day cannot be granted unless the applicant has filed its supplier information by that day.
Who it affects. Canadian importers and distributors, and Class I manufacturers that hold an MDEL. Foreign manufacturers are not named, but their supply chains now become visible: the importer reports who it buys from.
What to do. If you sell into Canada through a distributor rather than directly to the importer, expect the importer to name that distributor to Health Canada. If your foreign distributor holds an MDEL only because the old rule required it, it may no longer need one. If you have an MDEL application pending, file the supplier list before 1 December. Annual licence reviews are due before 1 April each year. On our reading of the amended section 46.1, the review due by 31 March 2027 is where most existing holders will file the list for the first time.
Also in Canada. Three other changes came out of the same set of shortage rules (SOR/2026-96, published 17 June 2026) or followed in the same period:
- Exceptional importation during shortages. On 2 September Health Canada moved forms FRM-0577 and FRM-0578 online. An importer must now give 3 business days' notice before an exceptionally imported device reaches the border, down from 5. A proposal to list a foreign-authorised device must name the foreign regulator and attach that regulator's authorisation and the manufacturer's quality-management certificate. It must also show the evidence of shortage, explain why the device is a suitable substitute, and give a last import date and a unit cap. GUI-0147 version 2 (7 October) revises the criteria for listing a device and adds a duty to report changes to the foreign authorisation. This is a route for relieving shortages, not a way into the market.
- Shortage and discontinuation reporting. GUI-0137 version 4, issued 7 October, applies from 17 June 2027. It covers manufacturers of devices in categories on Health Canada's shortages list, and importers of Class I devices in those categories. If you sell listed categories in Canada, update your reporting procedure before then.
- Special Access Program. On 24 August Health Canada introduced a new application form and secure submission routes for clinicians requesting unlicensed devices. From 1 February 2027 it accepts only those. If your device reaches Canadian patients through special access before it is licensed, as many early-stage devices do, update the instructions you give clinicians.
Mexico: new labelling rules from May 2027, including for software
What changed. NOM-137-SSA1-2025, Etiquetado de dispositivos médicos, was published in the Diario Oficial de la Federación on 19 May 2026 and replaces the 2008 standard. Section 11 says it takes effect 360 calendar days after publication, which by our count is 14 May 2027. Under its second transitory article, devices whose labelling cannot be changed in time get a further 180 calendar days to use up packaging and finished stock. By our count that runs to 10 November 2027.
Three provisions matter most to a foreign manufacturer:
- Software as a medical device gets its own rules. SaMD must carry an identifier, such as a version, revision level or release date, and the intended user must be able to see it. The only exception is a device with no wired or wireless electronic interface. Software with no physical form or packaging may carry its labelling electronically, reached through the software itself or a website. Mobile apps that meet the definition are expressly SaMD.
- Electronic labelling can supplement the label, but not replace it. Labels and instructions for use may be supplemented through RFID, barcodes, QR codes or a website, but the electronic content must not replace or contradict what was authorised.
- Spanish, and consistency with the registration. Label content must be in Spanish and must match the registration certificate COFEPRIS issued. Where the original label lacks required information, it goes on a supplementary label that does not cover required information.
Who it affects. Everyone with a Mexican registration, especially software companies, because the identifier rule shapes the product's user interface, not just its packaging.
What to do. Add the Mexican requirements to your next label revision, not at the last minute. For software, show the version or release identifier inside the app and give users an in-software route to the labelling.
Not for devices: the 2 September 2026 agreement creating an abbreviated route that recognises Brazilian approvals covers medicines registrations. Its title says so, and the text never mentions devices.
Colombia: supply reporting is law, but device reporting has not started
What changed. The health ministry's Resolución 1763 de 2026 (signed 5 August, published in Diario Oficial 53.618 on 7 September) creates SISCAATS, a central system for supply alerts on medicines and medical devices, including in-vitro diagnostics. Device marketing-authorisation holders and importers must report three things: units available for immediate sale, monthly within the first eight calendar days; short-term availability and units distributed, when the Ministry asks; and incidents that threaten supply, at any time. If an incident leads the holder to stop marketing a product, temporarily or permanently, it must also notify INVIMA.
Three details narrow this considerably for devices:
- Availability reporting applies only to devices on a priority list that the Ministry will publish and update, with at least ten days' notice before each reporting period (art. 6, para. 1).
- Device reports cannot start until the Ministry publishes a standardised reference table. It has given itself at most six months from publication to do so. Until then, holders and importers answer INVIMA's requests when a shortage is a risk (art. 15).
- Each report type becomes mandatory two months after it is switched on, with a no-penalty test period before that (art. 16).
So the resolution is in force, but monthly device reporting has not begun. If the Ministry meets its own deadline, the outer limit for switching it on is early March 2027 by our count, with mandatory reporting about two months later.
Who it affects. Whoever holds your Colombian registration or imports your product. That is often the local partner, which makes this a contract question.
What to do. Agree now who files SISCAATS reports and who decides to notify INVIMA of a stop in marketing, and put both in the distribution agreement. Then watch for the Ministry's device priority list.
What has not happened: the decree that would replace Colombia's device registration regime has not been issued. On 5 August 2026 the Ministry published its responses to the public consultation on the draft. As at 19 October 2026 the decree is not on the Ministry's list of instruments. Until it is, the current rules apply.
Chile: the scope of the new regime is now clearer, but registration has not opened
What changed. Exempt Decree 25 of 2026 (Diario Oficial, 19 March 2026) brings 39 categories of devices and in-vitro diagnostics under ISP registration. Once each category's date arrives, those products may be made, imported, sold or distributed in Chile only with an ISP registration (art. séptimo). On 1 October 2026, ISP published Material Informativo N° 1, a table that sets out, for each of the 39 entries, the device type, the risk class, examples of what is and is not covered, and the deadline.
- Scope: devices in classes II to IV and in-vitro diagnostics in classes B and C. The four class II entries are continuous glucose monitoring, automatic blood-pressure monitors, CPAP/BPAP and steam or ethylene-oxide sterilisers.
- Timing: 13 entries at 24 months, mostly class IV implants plus insulin pumps and blood bags, and the other 26 at 36 months, both counted from 19 March 2026.
- Software: two class III SaMD entries. One is software that processes and analyses oncology images, explicitly including AI/ML-based analysis; the other is radiotherapy treatment-planning software. ISP lists PACS, generic image viewers, workflow and administrative software as out of scope.
ISP describes the table as descriptive and "no limitante", meaning the examples do not limit the scope. It is not the technical instruction (instructivo técnico) that opens voluntary early registration. The decree requires that instruction within 12 months of publication, so by 19 March 2027 by our count. As at 19 October 2026, ISP's device agency page carried the scope table but no instruction. The decree also says that a significant change after registration requires a new registration, not an amendment (art. sexto), and that family and system registrations are allowed (art. quinto).
Who it affects. Makers of anything in the 39 categories who sell in Chile or plan to, and especially AI imaging companies in oncology.
What to do. Check your products against ISP's include and exclude columns, not the decree's bare category names. Have your dossier ready for the day the instruction is published: voluntary registration before the mandatory dates means you are not filing in the same queue as the whole market.
Separately, ISP consulted on a draft vigilance guide for devices from 27 August to 27 September 2026. The final version has not been published.
Argentina: an ISO 13485 route for foreign factories
What changed. ANMAT's Disposición 6403/2026 (published in the Boletín Oficial on 6 October, in force the next day) sets out how ANMAT certifies good manufacturing practice at device and IVD factories outside the country that Mercosur's inspection regime does not cover. The certificate is used for product registration applications and later changes. The Argentine importer applies, with a sworn request, the fee, its ANMAT authorisation and a current ISO 13485 certificate from a certification body accredited by a member of the ILAC or IAF networks, with proof of that accreditation. ANMAT's device institute has 40 business days to assess the initial file. Depending on its risk analysis, it may issue the certificate, ask for more information (which stops the clock), or verify remotely or on site. Recertification can be requested in the 60 business days before expiry, and applications already in progress move to the new rules.
Who it affects. Every foreign manufacturer outside Mercosur that registers devices in Argentina, through its importer.
What to do. Check that your ISO 13485 certificate comes from an accredited body and covers every factory and product category you will file for. ANMAT accepts one certificate per application, so factories covered by different certificates need separate applications.
Also in Argentina. Disposición 5461/2026 revised ANMAT's fees from 1 September 2026 and capped the fee charged on each device import operation at ARS 5,000,000. That is the August 2026 figure, and peso amounts change often. On 10 September ANMAT published a notice explaining how existing rules (Disposición 64/25) apply to software as a medical device. It says that health apps on wearables, such as ECG and atrial-fibrillation detection, irregular-rhythm alerts and sleep-apnoea detection, must be registered. This is a notice about rules already in force, not a new rule.
What this means for software and AI
Three of the five markets moved on software in this period, and in three different ways. Mexico regulates how software is identified and labelled: from May 2027 the version must be visible to the user. Chile regulates which software is in scope: AI oncology imaging and radiotherapy planning are in, while viewers and PACS are out. Argentina has stated that consumer wearable health functions are devices. If you sell software across Latin America, these are three separate checks.
What this means for startups
- Chile is the one opening in this list. A first-market company in an in-scope category can register voluntarily as soon as the instruction appears, ahead of the mandatory dates in 2028 and 2029.
- Get your ISO 13485 certificate from an accredited body. Argentina now accepts it as the basis for its foreign-factory certificate, and an accredited certificate is the one other regulators are most likely to accept too.
- Before licensing in Canada, special access is often how a device first reaches patients. Update the forms you give clinicians before February 2027.
The short version
- Canada: plan for 1 December 2026, not 14 December. Your importer starts listing its suppliers, and foreign distributors lose the need for their own licence.
- Mexico: update labels before 14 May 2027, and add a visible version identifier to software.
- Colombia: the supply-reporting resolution is in force, but device reporting starts only after the Ministry publishes its list and reference table. Settle who reports before then.
- Chile: check the 39-item scope table now, and be ready for the technical instruction, due by March 2027.
- Argentina: an accredited ISO 13485 certificate is now the basis for foreign-factory certification.
In four of the five markets, the obligation falls on the local holder or importer. Which partner holds your registrations, and what the contract makes them do, matters more after this quarter than before it. Our Latin America assessment covers who can hold a registration in each market.