Appointing the Tecnovigilancia Responsible Person in Chile

1. Key takeaways

Chile’s tecnovigilancia system requires the formal appointment of a tecnovigilancia responsible person (Responsable de Tecnovigilancia) and a backup, and notification to the ISP of the appointment and of any subsequent change. The ISP consultation draft of the National Tecnovigilancia System Guide makes the requirement more concrete: both the responsible person and the backup must have a contractual relationship with the Chilean entity and must perform the role within Chilean territory. In parallel, the ISP already requires designation of a tecnovigilancia contact at the company-registration stage.

GRZAN’s assessment: this role is the single point of failure of post-market compliance. A vacant position, an unqualified appointee, or an unreported change makes the company’s reporting obligations impossible to perform in form — reports go nowhere, notifications arrive late, and the statutory duty is breached even if the underlying safety work was done. The role is also the human link in the shortest deadlines of the system: when a sentinel event occurs, the person who must recognise, classify and file the report within 2 working days is this appointee. Everything else in the vigilance programme depends on that person existing, being reachable, and being formally registered with the authority. It is also the position through which the ISP’s queries and case-specific requests enter the company, which means the quality of every regulatory interaction after an incident depends on how well this single appointment was designed.

2. Legal basis

• ISP public consultation | National Tecnovigilancia System Guide | launched August 27, 2026, consultation period until September 27, 2026 | formal appointment of a tecnovigilancia responsible person and a backup, both required to have a contractual relationship with the filing entity and to perform the role within Chilean territory; the appointment and its subsequent changes must be notified to the ISP.
• General Technical Norm on patient safety and the safe use of medical devices | Norma General Técnica N° 204 | issued December 21, 2018 | requires designation of tecnovigilancia responsible persons at each level of the three-level operation (national, territorial, local), as the single communication channel.
• ISP filing requirement | company registration (Inscripción de Empresa) | a tecnovigilancia contact must be designated at registration.
• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 28: post-market reporting obligations.
• ISP forms | ANDID/006 (devices), ANDID/010 (IVDs), ANDIM/012 (FSCA and recalls).

3. Expert insights

Insight one: the responsible person plus backup design exists to prevent a single-point vacancy.

The guide requires the appointment of both a responsible person and a backup. This is not a formality: the reporting deadline for sentinel events is 2 working days, and if the responsible person is on leave or has left the company with no backup in place, the company loses, as a practical matter, the ability to report on time. The backup is not a courtesy title but the structural insurance for the harshest deadline in the system, and it should be trained, credentialed and plugged into the same reporting chain as the primary appointee.

Insight two: performing the role within Chilean territory is a hard condition.

The consultation draft expressly requires the responsible person and the backup to perform their duties within Chilean territory and to have a contractual relationship with the entity. This rules out appointment of staff of the foreign parent company, and equally rules out nominal designation of distributor personnel with no contractual relationship to the licence holder. Remote performance from another country may look operationally equivalent, but it fails the formal condition — and formal conditions are exactly what inspections verify first.

Insight three: both the appointment and its changes must be notified to the ISP.

The guide requires notification of the appointment and of any subsequent change. A change of person without notification leaves the old contact standing in the ISP’s system — queries and notices reach the wrong person, while legal responsibility stays with the company. The notification duty therefore has to be wired into the HR offboarding process, not left to the vigilance function to remember.

Insight four: Norma N° 204 places a responsible person at every level of the network.

Healthcare institutions operate the three-level structure (national, territorial, local), each with a responsible person acting as the single communication channel. The company-side counterpart must understand this structure; otherwise reports linger between levels and deadlines expire while the file sits at the wrong tier. Knowing who sits at each level is part of the company’s own preparedness.

4. Practical recommendations

1. Appoint the responsible person and the backup simultaneously, and state in the agreement the conditions that trigger substitution between the two, so the handover is automatic rather than negotiated during an event.
2. Ensure both individuals have a contractual relationship with the Chilean entity and perform the role within Chilean territory, avoiding foreign-parent dual hats and nominal appointments without contractual ties.
3. Notify both the appointment and any change to the ISP, and retain the notification receipts as evidence of the completed duty.
4. Integrate the responsible person into the 2-working-day response chain, with system accounts and templates that allow direct filing of reports without intermediate approvals.
5. Complete the designation of the tecnovigilancia contact at the company-registration stage, not after the certificate arrives.

5. Verification checklist

• □ The tecnovigilancia responsible person and backup have been appointed
• □ Both individuals have a contractual relationship with the Chilean entity and perform the role within Chilean territory
• □ The appointment has been notified to the ISP and the receipt retained
• □ The change-notification procedure is written into the SOP
• □ The tecnovigilancia contact was designated at the company-registration stage

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.