Chile Medical Device Regulation 2026–2029: Outlook and Action Plan

1. Key takeaways

Chilean medical device regulation is in a three-year restructuring period: Exempt Decree N° 25/2026 of March 19, 2026 brought 39 categories into registration control; around March 2027 the ISP must issue technical guidance (a 12-month statutory deadline); in March 2028 implants and higher-risk products require a certificate (24 months); in March 2029 the remaining products require one (36 months). In parallel, the tecnovigilancia system is being rewritten through the National Tecnovigilancia System Guide (consultation launched August 27, 2026).

GRZAN offers manufacturers three forward judgements: the list will keep expanding — the delegated-legislation structure of Article 111 letter d) determines this; queuing will become the dominant variable, because the ISP must verify the 39 new categories itself; and post-market obligations will tighten before registration obligations do — the direction of the tecnovigilancia guide revision is already clear. Reading the three trends together, the sequencing conclusion follows naturally: a manufacturer that resolves its licence-holder architecture and its vigilance staffing first, and its registration dossiers second, spends less and keeps more control than one that does the reverse.

2. Legal basis

• Listing of medical devices under the sanitary control regime of Article 111 | Decreto Exento N° 25, de 2026 | March 19, 2026 | 39 categories included; 24 / 36 month transition periods; 12-month deadline for technical guidance; significant changes require a new registration application.
• Sanitary Code | DFL N° 725, de 1967 | Article 111 letter d) | category-by-category implementation through reasoned decrees (the legal mechanism for expansion); Article 111 letter b) | the ISP performs verifications itself where no private body exists.
• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Articles 20, 21, 22, 26, 28, 30.
• ISP public consultation | National Tecnovigilancia System Guide | launched August 27, 2026 | intended to replace previous versions (not in force as of the verification date).
• General Technical Norm on patient safety and the safe use of medical devices | Norma General Técnica N° 204 | published January 16, 2019 | the current basis of tecnovigilancia.

3. Expert insights

Insight one: expansion will not stop at 39 categories.

Article 111 letter d) hands the initiation power to the Ministry of Health, acting on the ISP’s proposal through a reasoned decree — no statutory amendment is required. Combined with the selection criteria of Exempt Decree N° 25/2026 (criticality, priority for class III/IV and C/D, ministerial programmes, adverse event history), products with adverse event records or products in public procurement catalogues are the highest-probability candidates for the next batch. Monitoring those two signals is cheaper than reacting to a decree after publication, and it gives planning teams a working forecast instead of a surprise.

Insight two: 2027 is the only low-cost window.

Guidance is due within 12 months (around March 2027), after which voluntary applications become possible. The ISP must verify the 39 categories itself, so queuing in 2027–2028 is inevitable. Setting the dossier-ready milestone at March 2027 is the only cost trough in this round of expansion: applications filed before the queue peaks are reviewed against the same requirements but with less waiting, and internal teams are not yet stretched across mandatory-deadline work.

Insight three: post-market obligations tighten before registration obligations do.

The tecnovigilancia guide draft already sets explicit deadlines and role requirements for manufacturers, importers and distributors (2 / 10 / 20 working days; 3 / 10 working days for FSCA and recalls; responsible person and backup). Registration obligations are still in transition, while post-market obligations are already being detailed — a company that concentrates all resources on registration will find gaps opening on the post-market side. Budgeting and staffing should reflect that asymmetry now, not after the guide takes effect.

Insight four: after three years, the real dividing line is who holds the certificate.

Once the 24-month and 36-month deadlines pass, every product on sale needs a certificate. Changing the licence holder at that point costs far more than it does today — because the distribution channel is already running on the existing arrangement. GRZAN recommends settling the licence-holder architecture in 2027 rather than accepting the distributor’s terms under pressure in 2028, when the alternatives have narrowed to one.

4. Practical recommendations

2026 (now until March 2027)

1. Complete the comparison against the 39-category list and output an SKU-level three-column table (on/off the list, classification, transition tier).
2. Start the common dossier foundation: ISO 13485, risk management plan and report, Spanish labelling and instructions drafts.
3. Process the CFS and Apostille document chain in parallel.
4. Settle the licence-holder architecture, writing on-demand transfer, termination handover and technical-file ownership clauses into agreements.
5. Appoint the tecnovigilancia responsible person and backup; complete company registration and warehouse authorisation.

2027 (guidance publication year)

1. Complete the gap comparison within 48 hours of ISP technical guidance publication.
2. File voluntary applications immediately to secure an early review position.
3. Update internal deadlines and forms (ANDID/006, ANDID/010, ANDIM/012) per the published tecnovigilancia guide.
4. Build a change impact assessment form covering design, materials, process and site, sterilisation, intended use and labelling, and software versions.

2028–2029 (mandatory certification period)

1. Certify implants and higher-risk products before March 2028 (the 24-month tier).
2. Certify the remaining products before March 2029 (the 36-month tier).
3. Review certificate information every 3 years and keep labels synchronised.
4. Annual six-dimension self-assessment: certificate consistency, labelling and instructions, batch traceability, warehousing and cold chain, tecnovigilancia records, distribution and authorisation chain.

5. Verification checklist

• □ The 39-category list comparison is complete and the SKU-level three-column table is output
• □ The common dossier foundation has started, with the CFS and Apostille processed in parallel
• □ The licence-holder architecture is settled and on-demand transfer clauses are in agreements
• □ The tecnovigilancia responsible person and backup have been appointed
• □ The dossier-ready milestone is set at March 2027
• □ The two mandatory deadlines (March 2028 / March 2029) are scheduled per SKU
• □ The annual six-dimension self-assessment mechanism exists

Regulatory information verified as of October 29, 2026.

GRZAN supports manufacturers, importers and authorised representatives with post-market compliance in Chile, including tecnovigilancia reporting, FSCA and recall execution, record-keeping systems and SEREMI inspection response. For a product-specific feasibility assessment or post-market compliance support for the Chilean market, contact the GRZAN regulatory team at info@grzanglobal.com.