NCh-ISO 16142 Principles: Building the Essential Principles Compliance Table

1. Key takeaways

Exempt Decree No. 25/2026 lists NCh-ISO 16142-1 (essential principles of safety and performance for medical devices) and NCh-ISO 16142-2 (the corresponding part for in vitro diagnostic devices) as conformity evaluation references, together with NCh-ISO 13485 (quality management systems) and NCh-ISO 14971 (risk management). These four documents form the evidence framework for the newly listed categories.

GRZAN’s working method is to build an essential principles compliance table (a GSPR-style table): the left column lists the principle entries, and the right side records applicability, the manner of conformity and the file number of the supporting evidence. This is the highest-return document in a Chilean submission — it paves the reviewer’s path in advance, and it turns a scattered dossier into a navigable structure that can be checked line by line against a published standard. Because the table mirrors the decree’s own references, it also survives personnel changes inside the company: anyone can regenerate the review logic from the same two columns.

2. Legal basis

• Decree listing devices under the sanitary control regime of Article 111 | Decreto Exento N° 25, de 2026 | March 19, 2026 | conformity evaluation is benchmarked against NCh-ISO 16142-1, NCh-ISO 16142-2, NCh-ISO 13485 and NCh-ISO 14971 and against the product-specific standards listed in the annex.
• Sanitary Code | DFL N° 725, de 1967 | Article 111(c) | control and quality testing follow the Chilean official standards approved by the Ministry of Health on the proposal of the national standardization body (INN); where no such standards exist, the standards approved by the Ministry of Health apply, based on the ISP’s proposal and on information from international organizations or foreign specialized bodies.
• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 21: performance evaluation follows Chilean official standards, or standards approved by the Ministry of Health where none exist.

3. Expert insights

Insight one: NCh standards are Chilean adoptions — same numbers, but versions must be checked.

The NCh-ISO series is the adoption of ISO standards by Chile’s national standardization body, the INN. The numbering matches the ISO designations, but the adopted edition may lag in time. GRZAN requires its clients, before submission, to compare the current NCh edition against the edition referenced in their ISO certificates; a version mismatch is a common cause of deficiency letters. A short written version statement, prepared once, prevents an avoidable round of clarification that would otherwise cost weeks inside the review queue. The check is cheap — one lookup in the INN catalog or one request to the certification body — compared with a deficiency round that costs weeks and a queue position.

Insight two: Article 111(c) provides a fallback path where no NCh standard exists.

The order of the provision is: Chilean official standards first; where none exist, standards approved by the Ministry of Health, which must be based on information from international organizations or foreign specialized bodies. This means that for new technologies without a corresponding NCh standard — certain SaMD and AI software, for example — an alternative path exists. But the absence of an NCh standard must be stated in writing as the premise; a sponsor cannot silently default to international standards and expect the reviewer to accept the substitution without justification.

Insight three: 16142 states principles, not test methods.

The 16142 series sets out essential principles of safety and performance; the actual test methods come from product-specific standards such as the IEC 60601 series for electrical safety or the ISO 10993 series for biocompatibility. A frequent scoring error is to answer test-method queries with the 16142 table. The correct structure is a three-layer progression: 16142 principles, then the product-specific standard, then the test report. Each layer answers a different question, and confusing the layers weakens the whole evidence chain. In practice GRZAN builds the table so that each principle row names the product-specific standard clause used to satisfy it, which makes the three-layer progression visible on a single page.

Insight four: in vitro diagnostics follow 16142-2, and the two must not be mixed.

The essential principles for IVDs sit in 16142-2, which is a different checklist from 16142-1 for devices. IVD sponsors should build a separate compliance table, with emphasis on the principles related to analytical performance (limit of detection, precision, interference, stability) and clinical performance (clinical sensitivity and specificity). Where a sponsor markets both devices and IVDs, keeping the two tables in separate files also prevents an accidental cross-reference that would misdirect the reviewer. Reusing a device-side table for an IVD submission signals unfamiliarity with the framework and generates avoidable queries.

4. Practical recommendations

1. Build an essential principles compliance table: principle entry, applicability determination, manner of conformity, evidence file number — one row per principle.
2. Check the current NCh edition against the edition cited in the company’s ISO certificates, and issue a written version statement.
3. Build the three-layer structure of principle, product-specific standard and test report; do not use the principles table as a substitute for test evidence.
4. Keep a separate table for IVDs, organizing analytical and clinical performance evidence under NCh-ISO 16142-2.
5. State the alternative path in writing for technologies without an NCh standard, invoking the hierarchy of Article 111(c) of the Sanitary Code.

5. Verification checklist

• □ The current editions of NCh-ISO 16142-1 (devices) and 16142-2 (IVDs) have been obtained
• □ The essential principles compliance table is complete (applicability, manner of conformity, evidence numbers)
• □ The NCh editions have been checked against the editions cited in the company certificates
• □ The three-layer structure of principle, product-specific standard and test report is in place
• □ A written alternative path is stated for every item without an NCh standard

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.