ANMAT Introduces Simplified Licensing Regime for Low-Risk Medical Device Manufacturers and Importers in Argentina

Key Summary

Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT) has announced that, with immediate effect, a new simplified licensing regime applies to manufacturers and importers of low-risk medical devices. Companies may obtain national sanitary authorization by submitting a sworn declaration through the Themis platform. The regime covers Class I and Class II medical devices and Class A and Class B in vitro diagnostic (IVD) products. ANMAT emphasizes that manufacturers and, where applicable, importers remain primarily responsible for the quality, safety and efficacy of the products they place on the market, and for post-market risk management.

Source and Applicability

• Source authority: National Administration of Drugs, Foods and Medical Devices (ANMAT), Argentina
• Original publication date: 4 March 2026
• Source: https://www.argentina.gob.ar/noticias/entra-en-vigencia-el-nuevo-regimen-simplificado-para-la-habilitacion-de-establecimientos
• Basis: Compiled from publicly available ANMAT information. Specific requirements remain subject to the latest official publications of the regulatory authority.

Full Translation of the Original Content

The National Administration of Drugs, Foods and Medical Devices (ANMAT) announces that, with immediate effect, the new simplified licensing regime for manufacturers and importers of low-risk medical devices has entered into force.

This new measure allows companies to obtain national sanitary authorization to manufacture and/or import medical devices in risk Classes I and II, as well as in vitro diagnostic medical devices in Classes A and B, through the Themis platform. Companies may alternatively continue to apply through the procedure set out in ANMAT Provision No. 7425/13 and its supplementary Provision No. 2096/22.

The core of the simplified procedure is the submission of a sworn declaration. Under Article 109 of Decree No. 1759/72 (2017 consolidated text), a natural or legal person may declare under oath that it complies with the applicable regulatory requirements and that it holds the corresponding supporting documentation.

ANMAT also reminds companies that the manufacturer, and the importer where applicable, is primarily responsible for ensuring the quality, safety and efficacy of the products it places on the market, and must comply with current health regulations, in particular the Good Manufacturing Practices established in ANMAT Provision No. 3266/13 or any future amendments thereto.

Manufacturers and importers should also take an active role in the post-market phase, proactively evaluating information relating to product use experience in order to identify, prevent or mitigate risks that may arise after the product is placed on the market.

Companies may access the Themis platform and consult the user instructions published by ANMAT.

AIMEILI Regulatory Interpretation

What this development means for medical device companies

When ANMAT publishes an update of this kind, companies should first determine whether it concerns regulatory policy, guidance or standards, recall or safety information, product performance, quality systems or post-market surveillance. Each category has a different impact on registration pathways, technical documentation, labelling and instructions for use, risk management and ongoing market maintenance, and should not be treated simply as general industry news.

For Chinese medical device manufacturers, the priority is to convert the news into executable compliance actions: confirm whether similar products, similar technology routes or similar risk points are affected; verify whether existing documentation still supports the requirements of the target market; and where necessary, update risk management, performance verification, clinical evaluation, labelling and instructions for use, distributor communications and post-market surveillance records.

Documentation that companies should review as a priority

Priority should be given to the intended use, classification rationale, ISO 13485 quality management system certification, risk management file, performance verification data, clinical evaluation or clinical evidence, labelling and instructions for use, authorization documents and any existing registration certificates.

Common risks

• Unclear or incorrect classification determinations
• Incomplete evidence chains across the technical documentation
• Labelling and instructions for use that have not been localized
• Unclear allocation of responsibilities with the authorized representative
• Insufficient arrangements for post-market maintenance

AIMEILI Perspective

For Chinese medical device companies planning to enter the Argentine market, ANMAT's simplified licensing regime for low-risk devices is a positive signal. By replacing the traditional approval process with a sworn declaration, the regime significantly lowers the barrier to entry for Class I and Class II active and non-active devices and for Class A and Class B IVD products. Companies should focus on the following points.

First, the change in the registration pathway. Previously, companies generally had to follow the longer approval process under ANMAT Provision No. 7425/13. They may now submit a sworn declaration online through the Themis platform and obtain authorization quickly. This means that products classified as low risk can complete registration faster, saving time and cost. However, companies must ensure that they fully comply with the applicable regulatory requirements and that supporting documentation is on file, because a sworn declaration is a legal statement and false representations carry legal liability.

Second, confirmation of product classification. Companies must accurately determine the risk class of their products: active and non-active devices must be Class I or Class II, and IVD reagents must be Class A or Class B. If the classification is inaccurate, use of the simplified procedure may render the registration invalid. Companies are advised to study the ANMAT classification guidance in advance or engage a professional organization to carry out a pre-classification assessment.

Third, quality management system requirements. The simplified procedure does not exempt companies from the obligation to comply with Good Manufacturing Practices (GMP). ANMAT explicitly requires compliance with Provision No. 3266/13 (equivalent to ISO 13485). Chinese companies must establish and maintain a quality management system that meets Argentine requirements, and manufacturing sites in particular must pass a GMP inspection, which may be remote or on-site. This is a potential challenge for first-time applicants and requires advance preparation.

Fourth, post-market obligations. Argentina emphasizes the manufacturer's and importer's responsibility for proactive post-market monitoring. Companies need to establish complaint handling, adverse event reporting and risk analysis systems, and periodically evaluate product use data. Importers must clearly allocate responsibilities with their Argentine local representative to ensure that post-market information is collected and submitted in a timely manner.

Overall, the simplified regime facilitates the export of Chinese low-risk devices to Argentina, but companies should not use it as a reason to lower compliance standards. Companies are advised to first confirm whether their product classification falls within the simplified pathway, complete quality management system documentation, and appoint a qualified Argentine local agent to perform importer responsibilities. Companies should also maintain communication with ANMAT and monitor the subsequent publication of detailed guidance.

Practical registration and documentation management

From the perspective of international medical device registration practice, information published by ANMAT should not be read simply as ordinary news. Companies should first determine whether it concerns regulatory policy, guidance or standards, product approvals, recall or safety information, quality systems or post-market surveillance, because each category corresponds to different internal actions. Where a company is progressing a registration project in the relevant market, the update should be added to the target-market regulatory tracking table to confirm whether it affects product classification, registration pathway, applicant entity, local agent responsibilities or certificate maintenance arrangements.

For Chinese medical device companies, the direct impact of ANMAT's simplified licensing regime for low-risk device manufacturers and importers is typically felt in documentation consistency and evidence chain management. Companies should review existing technical files, risk management reports, performance verification data, clinical evaluation or clinical evidence, labelling and instructions for use, quality management system certificates and post-market surveillance documents to confirm that they still support the latest regulatory expectations of the target market. Where the information concerns safety notices, recalls, product approvals or regulatory meetings, companies should also assess whether similar products, similar technology routes or similar risk points are likely to receive particular attention from reviewers.

At the operational level, AIMEILI recommends three actions. First, record the official source link, publication date, applicable product scope and potentially affected areas in the regulatory tracking register. Second, have regulatory affairs, quality, R&D and sales jointly determine whether labelling, instructions for use, clinical evaluation, risk management or test reports need to be updated. Third, where the company already markets products locally or has submitted a registration application, assess in parallel whether the local agent, importer, distributors and after-sales team need to take communication, change notification, supplementary clarification or post-market surveillance measures.

The value of this type of news lies not simply in knowing what a regulator has published, but in converting public information into executable compliance actions. Companies preparing for multi-country registration should pay particular attention to the boundaries of documentation reuse between markets: the same set of CE, FDA, NMPA, ISO 13485 or MDSAP documentation may serve as core evidence in one country, while in another it may require supplementary localized explanations, language-specific labelling, authorized representative documentation or a post-market maintenance plan. AIMEILI recommends that companies conduct a brief documentation gap review after each significant regulatory update, so as to avoid becoming reactive during later deficiency responses, change notifications or certificate renewals.

FAQ

Can the ANMAT simplified licensing regime for low-risk medical device manufacturers and importers be used directly as a basis for regulatory submission?

No. This article is intended for preliminary understanding and project assessment only. Formal submissions must be based on the latest requirements of the target country's regulatory authority, the concluded product classification and the company's actual documentation status.

What should a company do first after seeing a relevant regulatory update?

The first step is to carry out a documentation gap assessment to confirm whether the update affects the registration pathway, technical documentation, labelling, quality management system or post-market maintenance obligations.

Does the simplified procedure remove the need for GMP compliance?

No. The simplified procedure relates to establishment licensing and does not exempt companies from compliance with Good Manufacturing Practices under ANMAT Provision No. 3266/13, which is equivalent to ISO 13485.

Content Review and Scope of Application

Content author: AIMEILI Regulatory Editorial Team. Professional review: AIMEILI Medical Device International Registration Project Team.

Source principles: Priority is given to official regulatory authorities, international organizations, standards bodies and publicly available regulatory materials; industry media and project experience are used only as supporting references.

Scope: This article is intended for preliminary understanding, documentation preparation and project planning. It does not replace the formal requirements of the target country's regulatory authority, testing conclusions or legal advice.