NEW MARKET – MEDICAL DEVICES & IVD
Mandala International, the key to your success in Chile!
Chile just overhauled its medical device and IVD regulatory framework. Enter this market with a local registration and legal representative who knows exactly how the new rules work.
A new 2026 decree adds dozens of device & IVD families to Chile’s mandatory registration regime with 24 to 36-month transition windows already running.
WHAT WE DO
OUR SOLUTIONS IN CHILE
Mandala Chile is being established to act as the local registration holder and legal representative of foreign medical device and IVD manufacturers before the Instituto de Salud Pública (ISP), the health authority, and its medical devices unit, ANDID.
We hold the local company structure, the physical address required for the sanitary licenses, and a designated local technical director, while authorized third parties can handle the physical import, warehousing and logistics, all governed by a documented tripartite quality agreement between manufacturer, real importer and Mandala Chile.
In addition to product registration, Mandala Chile will manage the full regulatory lifecycle : modifications, renewals, technovigilance and post-market obligations. So you remain independent and free to choose your own commercial and distribution partners in Chile.
THE 2026 DECREE
WHY THIS IS THE MOMENT TO REGISTER IN CHILE
39 new categories of devices and IVDs
The 2026 decree pulls cardiac implants, imaging equipment, dialysis devices and more IVD panels into mandatory ISP registration.
24–36 month windows
Each product family has a fixed transition deadline already running. Higher-risk devices have the shortest runway.
Early certification counts
Voluntary early registration becomes the final registration, no second procedure or fee once the deadline hits.
No more equivalency route
The old cross-country equivalency pathway disappears under the new decree. Every product needs its own Chilean file.
REGISTRATION IN CHILE
PRODUCTS REGISTRATION
The new decree brings dozens of additional medical device families from cardiac implants and stents to imaging and dialysis equipment into ISP’s mandatory sanitary registration regime, on top of families already regulated before 2026 (surgical gloves, condoms, hypodermic needles and syringes, automatic external defibrillators…).
GENERAL GUIDELINES
- Registration must be requested by a legally constituted Chilean company with a designated local technical director.
- Risk classification (Class I to IV) determines the applicable technical file and testing requirements.
- Sanitary registration is valid for 3 years, automatically renewable while obligations are met.
- Higher-risk device families benefit from transition windows of 24 to 36 months before registration becomes mandatory.
- No local factory audit is required: ISO 13485, a CE certificate or an equivalent GMP certification is accepted as proof of the manufacturer’s quality system.
ISP classifies IVDs from A (lowest risk) to D (highest risk) : examples range from buffer solutions (A) and pregnancy tests (B) to Chagas detection kits (C) and SARS-CoV-2 or HIV kits (D). The 2026 decree adds new mandatory families such as HPV, H. pylori and respiratory virus panels, alongside IVDs already regulated beforehand (HIV self-tests and professional-use tests, blood-bank immunohematology reagents).
GENERAL GUIDELINES
- Higher-risk IVDs (Class C & D) can require physical sample testing in ISP’s own laboratories as part of the conformity evaluation.
- The real importer remains responsible for any local release testing needed to clear each shipment for sale, and must issue Mandala the corresponding certificate of analysis.
- Typical registration timelines run 60 to 90 business days once the technical file is submitted.
- Self-test products additionally require usability studies demonstrating safe use by a layperson.
WHAT WE DO
OUR SERVICES
COMPANY REGISTRATION
FAST-TRACK PRODUCT PRE-REGISTRATION
LICENSE HOSTING & LEGAL REPRESENTATION
TECHNOVIGILANCE & POST-MARKET SURVEILLANCE
DOCUMENTARY REVIEW & ISP CERTIFICATE OF ANALYSIS
DISTRIBUTOR & IMPORT COMPLIANCE FRAMEWORK
SCOPE OF THE NEW REGIME
IS YOUR PRODUCT SUBJECT TO REGISTRATION?
Every manufacturer selling into Chile must be declared in ISP’s system, regardless of whether each product itself requires full sanitary registration.
SUBJECT TO REGISTRATION
- Medical devices, Class III & IV
- IVDs, Class C & D
- Cosmetics and medicines
- Disinfectants, via the SAFIS platform
We handle classification, registration and its modifications, license hosting and technovigilance for this category.
NOT YET SUBJECT TO REGISTRATION
- Lower-risk medical devices, Class I & II
- Lower-risk IVDs, Class A & B
We focus on classification and a documentary review supported by ISP, anticipating future registration requirements and strengthening your position in public tenders.
Note: food supplements require a separate license and dedicated warehouse managed by SEREMI, and fall outside Mandala Chile’s current scope.
Not sure whether your product needs to be registered in Chile?
GET IN TOUCH
CONTACT US
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ABOUT MANDALA CHILE
FREQUENTLY ASKED QUESTIONS
Yes. Chilean law requires any foreign manufacturer wishing to market pharmaceuticals, medical devices, or cosmetics to appoint a Local Regulatory Representative established in Chile. Mandala International acts as your legal bridge, holding the sanitary registrations on your behalf while ensuring you maintain full commercial independence and control over your distribution network.
Since March 2026, the ISP (Instituto de Salud Pública) has implemented a phased mandatory registration for 39 new categories of medium and high-risk devices and IVDs. Companies now have a strict timeline (24 to 36 months) to comply. Mandala helps you navigate this transition to avoid market withdrawal.
The timeline varies based on the product’s risk classification. On average, registration for medical devices takes 6 to 10 months, while pharmaceutical products can take up to 18 months. Utilizing Mandala’s expertise and leveraging the new regulatory reliance mechanisms introduced in March 2026, can significantly streamline these timelines by ensuring your technical dossier meets ISP standards.
Absolutely. Beyond product registration, the Chilean authorities (SEREMI de Salud) require that the facilities used for storage and distribution meet strict sanitary standards. Mandala supports you in obtaining the Resolution of Sanitary Authorization for your local infrastructure or assists in auditing your chosen third-party logistics (3PL) provider to ensure full compliance with Good Storage and Distribution Practices (GSDP).
Choosing a distributor as your registration holder can lead to a huge commercial risk. If you wish to change distributors, transferring the registration can be a long and costly legal process. By choosing Mandala as an independent partner, you own the market access rights. You remain flexible to appoint, change, or add multiple distributors without ever risking your presence in the Chilean market.
WHERE WE DO
OTHER LATAM COUNTRIES IN WHICH WE OPERATE
LATAM EXPENSION PACK
Thinking of a global expansion in Latin America, Mandala International helps you access several markets faster through one regional regulatory strategy and benefit from exclusive discounts. Learn more about Mandala international’s LATAM EXPANSION PACK.