The draft is available for public comment on the ISP website through September 27, 2026.
The Chilean Institute of Public Health (ISP) has published for public consultation the draft of the Fifth Edition of the National Technovigilance System Guide, prepared by the Surveillance Subdepartment of the National Medical Devices Agency (ANDIM).
The document updates and replaces the currently valid version and applies to all medical devices and in vitro diagnostic medical devices that are manufactured, imported, distributed, or used in the country.
The Guide is the instrument through which the ISP interprets and implements, among other regulations, Article 28 of the Regulations on the Control of Medical Products and Devices and General Technical Standard No. 204 on Patient Safety and Quality of Care Regarding the Safe Use of Medical Devices: Technovigilance.
It is worth noting that this update is expressly aligned with the ISP’s goal of gradually complying with the guidelines of the World Health Organization’s Global Benchmarking Tool, as well as with the guidance of the International Forum of Medical Device Regulators.
This suggests that future regulatory updates in this area will continue to align with international standards, a relevant consideration for manufacturers already operating under such frameworks in other jurisdictions.
The draft is open for public comment on the ISP’s website from August 27 to September 27, 2026.
I. Structure and Scope of the Guidance
The Guidance is organized around three central pillars:
- The National Technovigilance Network, which operates at three levels—national, regional, and local—and includes the Ministry of Health, the ISP, the Health Services, the Regional Ministerial Secretariats of Health (SEREMI), and manufacturers, importers, distributors, and healthcare providers;
- The Adverse Event and Incident Reporting System;
- The Alert System, through which Field Safety Corrective Actions and Field Safety Notices are disseminated.
The Guide devotes separate chapters to each stakeholder in the Network—healthcare providers, Health Services, and SEREMI—and, in particular, to manufacturers, importers, and distributors, reflecting that the latter bear the most demanding obligations regarding investigation, risk assessment, and corrective actions.
The document also includes five appendices covering instructions for accessing the “Integrated Surveillance System (SVI)” platform, useful links, a list of situations exempt from reporting with practical examples, and the basic content required for Technosurveillance manuals, both for healthcare providers and the industry.
II. Main Changes in the Draft
1.Data Protection and Clinical Confidentiality. A new section has been added that expressly subjects the processing, traceability, recording, and reporting of health information carried out through the SVI and the records of implantable devices to Law No. 19,628 on the Protection of Privacy and to the confidentiality obligations of Law No. 20,584.
2. Formal requirements for the industry’s technovigilance officer. Manufacturers, importers, and distributors must designate a technovigilance officer who is a healthcare professional or who can demonstrate proven and documented experience in the field, maintains a contractual relationship (as a full-time employee or contractor) with the company, and has an office or place of work within the national territory. This appointment, along with that of the technical officer and their alternate, must be formally registered with the ISP.
3. New certified registration service in the National Network. Since January of this year, the ISP has offered the service “Registration of Manufacturers, Importers, or Distributors of Medical Devices with the National Technovigilance Network,” which issues an official certificate attesting that the company has a duly appointed technovigilance officer and a current manual. This certificate can be used as a means of verification in public bidding processes, which gives it immediate practical relevance for companies participating in public procurements.
4. Three milestones for the investigation of sentinel events[1]. The Guide structures the investigation of these events into three stages:
An initial response upon receipt and notification to the manufacturer (within 20 business days), An interim follow-up response (an additional 20 business days), and A final report (within 60 business days of the initial notification), each with required minimum content.
5. Usage errors and abnormal use[2]. A clear distinction is made between reportable usage errors (those resulting in death, serious injury, or a threat to public health), usage errors not individually reportable (managed internally, unless there is a change in trend), and abnormal use itself, the management of which falls under the responsibility of the healthcare facility and local authorities, not the manufacturer.
6. Differentiated deadlines for reporting FSCA. A deadline of 3 business days is set for market recalls and for FSCA associated with events involving death or permanent harm with a high probability of occurrence, and 10 business days for all other FSCA, counted from the time the company becomes aware of the situation.
7. Strengthened operational requirements for product recalls. Written procedures must be in place to initiate a recall at any level of the distribution chain; electronic distribution records must be available to the ISP; personnel must be designated to carry out and coordinate the recall; and a segregated area must be designated for storing recalled products. The final report must reconcile the units distributed, consumed, and recalled, supported by notarized certificates of destruction or shipping documents.
8. Strengthened content of the Field Safety Notice (FSN). The Guide details a list of minimum elements that every FSN must contain—medical device identification, description of the defect, summary of the investigation, recommended measures, contact information, and implementation deadlines—and expressly prohibits the inclusion of comments that downplay the risk or constitute misleading advertising.
9. Consolidation of the Integrated Surveillance System (SVI). The SVI, in effect since 2023, is reaffirmed as the sole reporting platform, with differentiated profiles (Facility, Professional, and SEREMI Professional, among others) that allow each stakeholder in the Network to monitor and manage their own reports.
10. New practical appendices. An appendix is included with specific examples of situations exempt from reporting—such as defects detected by the user prior to use or events attributable to a patient’s preexisting medical condition—as well as appendices containing the basic required information.
[1]The Guide defines a sentinel event as one related to the use of a marketed medical device that affects the patient and that directly or indirectly causes, or could cause, death or serious physical or psychological injury.
[2]“Abnormal use” means an action or omission by a user that exceeds any risk control measures reasonably adopted by the manufacturer (e.g., sabotage, unauthorized tampering with the device, or gross negligence).
III. Impact by Type of Stakeholder in the National Network
- Healthcare providers (public and private). They must ensure that their internal pharmacovigilance manual, their local network of reporters, and their event validation criteria comply with the new standards. In addition, an assessment will be conducted to determine whether their data management system meets the traceability and retention requirements set forth in the Guidance.
- Manufacturers, importers, and distributors. These entities face the greatest number of new requirements, as they must verify that their pharmacovigilance officer meets the formal requirements, assess the advisability of applying for the new certified registration, and review their internal procedures for investigating sentinel events and managing FSCA in light of the new deadlines and milestones.
- Health Services and SEREMI. They maintain their role in coordinating and supervising the local network and must report quarterly on the status of their network to their higher authorities. The SEREMIs also retain their oversight role in serious situations related to an Alert or FSCA, and the ISP may request that they initiate an oversight process.
You can download the complete draft and respond to the consultation here.
For more information on these topics, please contact our Public Law and Regulated Markets team:
Antonio Rubilar | Partner | arubilar@az.cl
Dafne Guerra | Life Sciences and Competition Director | dguerra@az.cl
Gonzalo Bravo | Public Law and Regulated Markets Group Director | gbravo@az.cl
Claudia Delgado | Associate | cdelgado@az.cl
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