Chile Medical Device Registration: The 24-Month vs 36-Month Transition Schedule

1. Key takeaways

Exempt Decree No. 25/2026 established a two-track transition period for the device categories newly brought under the sanitary control regime of Article 111, and both tracks run from the publication date of 19 March 2026: implantable and other higher-risk devices receive 24 months (expiring around March 2028), while all remaining products receive 36 months (expiring around March 2029). GRZAN does not plan client projects backwards from these two statutory deadlines. Instead, we treat March 2027 — the expected release point of the ISP technical guidance — as the first hard milestone in the schedule, because the real bottleneck year is not 2028 but 2027.

The reasoning is straightforward. The ISP must carry out conformity verification for the newly listed categories on its own, and no accredited private verification body is currently available to take over that task. Review capacity is therefore limited, and manufacturers that intend to move early will concentrate their submissions right after the guidance is published. As a result, the queue will build up sharply across 2027 and 2028, and every month of delay in preparation translates directly into lost queue position.

A second consequence deserves equal attention. The decree is explicit about what happens when a transition period expires: products on the listed schedule that have not obtained sanitary registration may no longer be manufactured, imported, sold or distributed in Chile. For a company with an established channel, that outcome is commercially far more damaging than the cost of the registration itself. Planning should therefore be driven by the earliest controllable milestone — the release of the technical guidance in March 2027 — and every upstream activity, from dossier engineering to apostille chains, should be measured against that date rather than against the statutory deadline.

2. Legal basis

• Bringing the listed devices under the sanitary control regime of Article 111 | Decreto Exento N° 25, de 2026 | 19 March 2026 | Transition period provisions: high-risk and critical implantable devices, 24 months; all other devices, 36 months.
• Same instrument | Transitional provisions: the ISP must publish technical guidance within 12 months of publication, defining the procedure and documentation requirements; once the guidance is issued, companies may voluntarily apply for conformity verification.
• Sanitary Code | DFL N° 725, de 1967 | Article 111, subparagraph b) | where no private bodies exist to carry out control and certification tasks, the ISP implements them itself.
• Regulation on the control of medical products and devices | Decreto Supremo N° 825, de 1998 | 21 August 1999 | Article 20 (classification) and Article 21 (documentation requirements by class).

3. Expert insights

Insight 1: the two tracks cut by product, not by company.

A single manufacturer’s coronary stent (Class IV) and its automatic blood pressure monitor (Class II) will fall on two different statutory deadlines. GRZAN therefore requires clients in Chile projects to build a SKU-level production and submission table rather than a company-level market plan. A company-level plan blends the two tracks into one average timeline and systematically underestimates the time pressure on the implantable product line, where the shortest transition period and the heaviest documentation requirements coincide. Every SKU should carry its own class, its own track, and its own target submission date.

Insight 2: for products on the 24-month track, the preparation time actually available is only about 12 months.

The logic chain is fixed: the guidance is expected around March 2027; submissions enter the review queue afterwards; the mandatory deadline for the 24-month track falls in March 2028. A manufacturer that waits for the guidance before starting work is left with roughly 12 months to complete dossier engineering, apostille evidence gathering, Spanish localization, and the unavoidable waiting period inside ISP review. Dossier engineering for Class III and Class IV products typically takes 2–4 months (practical estimate), and one or more deficiency rounds must be added on top of that. Measured against the 12-month window, the time available for starting is effectively negative.

Insight 3: the 36-month track cannot be pushed back either, because IVDs and imaging equipment carry higher documentation complexity.

Thirty-six months looks comfortable, but in vitro diagnostic devices need a complete analytical performance evidence chain, and imaging equipment needs a full set of electrical safety and performance reports. Their documentation cycles are not shorter than those for implantables. The real difference between the two tracks lies in the distribution of review queue pressure: the later a submission arrives, the closer it sits to the deadline surge around 2029, when every remaining company on the 36-month track files at once.

Insight 4: the consequence after the transition expires is a prohibition on manufacture, import, sale and distribution — not a fine.

Products on the listed schedule that have not obtained sanitary registration once the transition period expires may no longer carry out any of those four activities. For companies that already have products in the channel, this means products currently on sale must be pulled from the market, a commercial loss that far exceeds the cost of running the registration on time. Treat the deadline as a market-access cliff, not as a compliance formality.

4. Practical recommendations

1. Build a SKU-level three-column table: product, class, and transition track (24 or 36 months), and mark the mandatory deadline month for each SKU.
2. Set March 2027 as the dossier-ready milestone, and plan backwards from that date — not backwards from the mandatory deadline.
3. Start implantable and Class IV products first: they combine the shortest transition period with the highest documentation requirements.
4. Complete the generic dossier base before the guidance is published: ISO 13485, the risk management report, Spanish labels and instructions for use, so that only product-specific parts remain after publication.
5. Insert registration progress milestones into distribution agreements, binding channel stocking to certificate milestones so that unregistered distribution never triggers a seizure.

5. Verification checklist

• □ A SKU-level three-column table of class and transition track has been produced
• □ The 24-month track list for implantable and higher-risk products has been confirmed
• □ March 2027 has been set as the dossier-ready milestone
• □ Generic base documentation (ISO 13485, risk management, Spanish labels and instructions for use) has been completed
• □ Certificate milestones and stocking conditions have been written into distribution agreements

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers entering the Chilean market with ISP registration pathways, transition-track planning and classification strategy, from SKU-level deadline tables to full dossier preparation. For a feasibility assessment of your specific product, contact the GRZAN regulatory team at info@grzanglobal.com.