Date: March 19h, 2026
The Chilean Ministry of Health (MINSAL) has recently published Exempt Decree No. 25, setting up a new health control regime for a wide range of medical devices (MD) and in vitro diagnostic (IVD) medical devices. This significant regulatory shift aims to align Chile with international safety and performance standards, ensuring that only high-quality and safe devices reach the market.
Understanding the new constraints
For manufacturers and distributors, this decree introduces several mandatory requirements to maintain market access:
- Mandatory registration: A total of 39 categories of medical devices (MD) and in vitro diagnostics (IVD) now require formal registration with the Institute of Public Health (ISP) before they can be legally manufactured, imported, or sold.
- Quality verification: Compliance must be proved through rigorous technical standards, including ISO 13485 and ISO 14971, ensuring traceability and performance.
- Staged implementation: To allow for industry adaptation, compliance deadlines are set from March 19, 2026 (date of publication), based on the device type:
- 24-month deadline: High-risk and implantable devices (e.g., cardiac pacemakers, stents, breast implants).
- 36-month deadline: Diagnostic equipment, clinical software, and laboratory tests (e.g., CT scanners, oncology software, HPV tests).
List of regulated devices
The regulation targets medium-to-high-risk technologies. Below are the products newly incorporated into the health control regime:
In Vitro Diagnostic (IVD) Medical Devices
- Helicobacter pylori detection tests.
- Human Papillomavirus (HPV) detection tests.
- Respiratory virus tests (Influenza A/B, RSV, SARS-CoV-2, etc.).
- Glucose monitoring systems (meters, strips, and lancets).
- Pregnancy and tumor marker tests (hCG).
Medical Devices (MD)
- Cardiovascular: Pacemakers, defibrillators, stents, heart valves, and cardiovascular catheters.
- Implants & prostheses: Cochlear implants, hip prostheses, breast implants, and surgical meshes.
- Specialized equipment: Insulin infusion pumps, blood bags, mechanical ventilators, and extracorporeal circulation equipment.
- Imaging: X-ray, Mammography, CT scanners, PET/SPECT, and radiotherapy equipment.
- Renal care: Hemodialysis equipment, filters, catheters, and concentrates.
- Other: Intraocular lenses, electrosurgical units, dermal fillers (hyaluronic acid), IUDs (copper), and sterilization equipment.
- Software: Software for oncological image processing and treatment planning.
How to operate in the meanwhile?
While manufacturers can continue to commercialize current and new products without registration until the respective deadlines, the ISP has introduced a voluntary early registration process. By applying ahead of schedule, they can avoid the bottleneck effect that could result in a lapse of market authorization and affect their business results.
In this context, the ISP issues a transitory certificate of conformity. This serves as a fast-track, allowing for a much faster conversion into the final sanitary registration when the deadline arrives. This certificate is already becoming a decisive factor in public tenders as government buyers seek to ensure that the products they get will remain legally compliant once the new regulations are fully active.
Mandala International : your new partner in Chile
To help our clients navigate this complex transition, Mandala International decided to open its subsidiary office in Chile.
While these new regulations introduce significant hurdles, they also stabilize the market by ensuring high quality and safety. Our local team will support your expansion by managing the entire ISP registration process, providing local representation, and ensuring your documentation meets the new Chilean technical standards before the 24 and 36-month deadlines.
Contact us for more details