Argentina Technical Report: Preparing Annex V of GMC 25/21

1. Key takeaways

The Argentine technical report must be prepared in the fixed format of Annex V of GMC 25/21, with five required contents:

1. Product description and working principle;
2. Intended use;
3. Precautions;
4. Production process;
5. Describe the safety and effectiveness of the product against the essential requirements of GMC 72/98.

The fifth item is the part most frequently overlooked by applicants, particularly by newcomers to the Argentine system: it is not a freely drafted performance narrative, but a point-by-point statement of conformity with the MERCOSUR essential requirements (GMC/RES 72/98). Treating it as a summary paragraph rather than a structured compliance matrix is one of the most reliable ways to generate a deficiency letter, because examiners look for an item-by-item mapping rather than a general assurance.

It also helps to understand why the regulator chose a fixed format. A uniform five-part structure lets examiners navigate reports from very different manufacturers at the same speed, and lets them find the essential requirements statement without hunting through differently organized files. A submission that follows the format exactly is therefore not merely compliant; it is cheaper for ANMAT to review, and a cheaper review is a faster review. Companies that respect the format also find their own internal reviews easier, because every reader knows where each type of content must appear.

2. Legal basis

The three instruments interlock: Annex V of GMC 25/21 dictates the structure of the report, GMC/RES 72/98 supplies the checklist of essential requirements that the fifth section must answer point by point, and Disposición ANMAT 64/2025 confirms the technical documentation obligations in domestic law. A report drafted without reference to any one of the three will be structurally incomplete from the examiner’s perspective.

A practical drafting order follows the same sequence as the annex itself. The first four sections, product description and working principle, intended use, precautions and production process, can be assembled largely from existing development documentation, while the fifth section, the essential requirements statement, is the only one that usually requires new work. Budgeting the effort accordingly, and starting the fifth section early because it drives the evidence collection, keeps the report from becoming the last document standing between the dossier and submission.

3. Expert insights

Insight 1: Annex V is a format specification, not a content guide. It prescribes which sections must appear and in what order, but not how deep each section must go. Depth is determined by the risk class: for Class III/IV the technical report must be able to independently support the conclusion of safety and effectiveness, otherwise ANMAT will require clinical studies; for Class I/II a statement of satisfaction of the essential requirements is the measure. Drafting to a single depth for all classes therefore either wastes effort on low-risk files or under-prepares high-risk ones.

Insight 2: the GMC 72/98 essential requirements statement is an Argentine-specific feature that CE documentation cannot simply replace. The general safety and performance requirements (GSPR) of the EU MDR are structurally similar to GMC 72/98 but do not map onto it one for one. Translating the CE conformity table directly leaves gaps in review, and the recommended approach is to rebuild the statement with the GMC 72/98 items as the skeleton, pulling evidence from the CE file into each row rather than reusing the EU table wholesale.

Insight 3: the production process section must be consistent with the GMP evidence. If the production process described in the technical report diverges from the scope of the ISO 13485 certificate or from the actual site layout, that inconsistency becomes a trigger for ANMAT to request supplementary material or initiate a site inspection. Cross-checking the three sources before submission is far cheaper than managing an inspection.

4. Practical recommendations

1. Build the conformity table on the skeleton of the GMC 72/98 items. Use four columns per item: the essential requirement, applicability, the means of satisfaction (standard / test / design control), and the identifier of the evidence file, producing a matrix an examiner can audit directly.
2. Align the intended use with the definitions chapter. The intended use wording must fit within one of the six medical purposes in the definitions of Disposición 64/2025, and must match the label and the IFU exactly, since any divergence among the three texts invites questions about the product’s claimed role.
3. Keep the production process description consistent with reality. Cross-check it against the technical file and the quality system documentation so that the three descriptions cannot drift apart, and update all of them together whenever the process changes.
4. Have the Spanish version done by a local regulatory translator. Technical terminology errors directly trigger deficiency letters; do not rely on machine translation for a document this central to the technical assessment.

5. Verification checklist

• □ Technical report prepared section by section against the five contents of Annex V
• □ Essential requirements conformity matrix completed against the GMC 72/98 items
• □ The four sections on product description and working principle, intended use, precautions and production process complete
• □ Intended use wording consistent with the label, the IFU and the definitions chapter
• □ Production process description consistent with the GMP evidence and the actual layout
• □ Spanish version completed and proofread by a local regulatory translation

Regulatory information verified as of October 29, 2026.

In Argentina, GRZAN operates a wholly owned subsidiary that can serve as the registration holder and importer of record for foreign manufacturers, directly handling classification assessment, pathway selection, building the GMP and CFS documentation chain, Spanish-language localization of technical documentation and labeling, HELENA submissions and responses to deficiency letters, as well as BONITA import notifications, operation of the ARGOS vigilance system, change maintenance and planning for the 5-year renewal. For support with registration dossiers and conformity documentation for the Argentine market, contact the GRZAN regulatory team at info@grzanglobal.com.

The GRZAN regulatory team consists of professionals with many years of hands-on experience in international registrations, tracks the activity of regulatory authorities across markets on an ongoing basis, and applies a writing standard of conclusions first, traceable sources and verifiable figures to everything it publishes. For a market access plan tailored to a specific product in Argentina or the wider MERCOSUR region, the GRZAN regulatory team welcomes your enquiry at info@grzanglobal.com.