ISP as Verification Body: Direct Conformity Assessment for the 39 New Categories

1. Key takeaways

For the 39 categories newly added by Exempt Decree No. 25/2026, there are currently no accredited private conformity verification bodies, and conformity verification is carried out directly by the ISP. This is not a provisional arrangement but the default branch anticipated by Article 111(b) of the Sanitary Code: when no private bodies exist to perform these tasks, the ISP performs them itself.

GRZAN identifies three operational corollaries of this arrangement: the dossier format is driven by document review; the ISP is simultaneously player and referee, so the quality of deficiency responses directly determines progress; and review queueing will be the main variable across 2027–2028. Each corollary changes how a submission should be planned, and each is examined in detail below.

2. Legal basis

• Sanitary Code | DFL N° 725, de 1967 | Article 111(b) | the ISP authorizes and inspects the bodies engaged in control and certification; when no private bodies carry out such tasks, the ISP performs them itself.
• Same instrument | Article 111(a) | control and certification must be performed by bodies expressly authorized by the ISP.
• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 3: the conformity verification certificate must be obtained beforehand; Article 6: an aggrieved party may appeal to the ISP within 15 working days from notification of non-conformity; Article 7: the body concerned must submit its explanations and documentation within 10 working days.
• Decree listing devices under the sanitary control regime of Article 111 | Decreto Exento N° 25, de 2026 | March 19, 2026 | for the newly listed categories, conformity verification takes the form of sanitary registration granted by the ISP, with the evidence evaluated through document review.

3. Expert insights

Insight one: under a document review regime, how evidence is organized matters more than how much evidence exists.

The ISP does not repeat design verification; it reviews whether the submitted documents demonstrate conformity with standards such as NCh-ISO 16142-1 and 16142-2. A well-structured 200-page package that maps onto the essential principles outperforms a disorderly 2,000-page pile. The first thing GRZAN does in such projects is usually to reorganize the table of contents, not to commission additional reports. Documents that cannot be located by the reviewer are, for practical purposes, documents that do not exist. In a document review regime the table of contents is also the reviewer’s first impression: a package whose structure is complete signals discipline, while a disordered pile invites suspicion about every layer beneath it.

Insight two: because the ISP holds both roles, the appeal route is an internal review.

The appeal mechanism of Article 6 of DS 825/1998 was designed around a third-party verification body, with the ISP acting as arbiter. When the ISP itself is the verification body, the 15 working days appeal window of Article 6 and the 10 working days explanation duty of Article 7 form an internal review path. The time limits remain fully effective, but the room for contestation narrows — which is why the quality of the first submission matters more than advocacy skill at the appeal stage. Budget the effort accordingly, at the front of the project rather than the end. In calendar terms this means locking the dossier scope early and treating any late change as a threat to the readiness milestone, not as a routine improvement.

Insight three: review capacity is a hard constraint, and early submission is the only real answer.

The ISP must verify the 39 new categories itself, while the mandatory compliance deadlines cluster around March 2028 and March 2029. Queueing risk cannot be negotiated away by talking to the ISP; it can only be avoided by submitting early. This is the underlying rationale for the production scheduling recommendations made elsewhere in this series. A dossier that is ready early competes against a shorter queue; the same dossier filed at the deadline competes against everyone else’s. Planning the submission around the queue also protects the commercial calendar: a launch date built on an early filing survives delay, while one built on a last-minute filing inherits every day of queue.

Insight four: once a private verification body appears, the process will change again.

The model of Article 111(b) presupposes the existence of private bodies. If an organization obtains authorization later, the verification route may fork. Sponsors should therefore build their documentation so that it stands whoever performs the verification — that is, fully aligned with the NCh-ISO standards rather than tailored to the ISP’s current review habits. Alignment with published standards is also the most defensible position if the review regime, the responsible bodies or the applicable guidance change during the multi-year transition.

4. Practical recommendations

1. Reorder the dossier and build a standards mapping: use the essential principles of NCh-ISO 16142-1 and 16142-2 as the organizing skeleton, pointing item by item to specific documents.
2. Prepare the first submission to a zero-deficiency standard: with the ISP in a dual role, the room for negotiation during the deficiency-response stage is limited.
3. Submit early to avoid queueing: set the documentation-readiness milestone around March 2027, not at the mandatory deadline.
4. Align documentation to the standards, not to review habits: preserve compatibility for the future entry of private verification bodies.
5. Know the time limits of Articles 6 and 7: start the 15 working days appeal clock on the day the non-conformity notification is received, and calendar the 10 working days explanation duty in parallel.

5. Verification checklist

• □ It is confirmed that the newly listed categories are verified directly by the ISP
• □ The dossier has been reordered against NCh-ISO 16142-1 and 16142-2 with a standards mapping in place
• □ The first submission has passed an internal review to a zero-deficiency standard
• □ The documentation-readiness milestone is set around March 2027
• □ The 15 working days appeal time limit is written into the project workflow

Regulatory information verified as of October 29, 2026.

For a product-specific feasibility assessment of Chile market entry, GRZAN’s regulatory team supports manufacturers and importers with registration dossiers, conformity documentation and ISP submissions. Contact info@grzanglobal.com to discuss your project.