Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) has issued Resolution 236/2026, implementing Decree 892/25, which relaxes regulatory controls on imported products classified as low- or medium-risk. The new rules eliminate certain pre-market registration requirements and replace them with a notification‑based filing system—a significant win for foreign trade businesses exporting to Argentina.
I. ANMAT Introduces New Simplified Import Regulations
ANMAT has enacted Resolution 236/2026 to give effect to Decree 892/25, streamlining the importation and domestic commercialisation processes for low- and medium‑risk products manufactured overseas.
The reform centres on a regulatory trust‑based model that reduces unnecessary duplicate testing and redundant certification, while maintaining rigorous product quality, safety and performance standards. The regulatory focus shifts from intensive pre‑market administrative scrutiny to robust post‑market surveillance.
II. Which Products Are Eligible for the Simplified Regime?
The simplified procedure applies exclusively to the following categories. High‑risk products are not covered:
- Class I and Class II medical devices (low‑risk and medium‑risk; Class III and Class IV high‑risk devices remain subject to the full registration pathway)
- Class A and Class B in vitro diagnostic (IVD) products that do not require a cold chain
- Household hygiene products
- Dental and oral hygiene products, personal care items, cosmetics, and fragrances
- Single‑use hygiene products for external use, and hygiene products for vaginal use
Key point: Class III and Class IV high‑risk medical devices continue to be subject to the existing stringent registration regime and do not benefit from this simplification.
III. Core Elements of the New Regulations
1. Business eligibility requirements remain unchanged
Importation and domestic sale of products must still be conducted by a company that is officially authorised and registered with ANMAT.
Prior to importation, the company must submit a sworn declaration through ANMAT’s digital platform to complete the notification filing. Without this filing, customs clearance is not permitted.
2. Local testing may be waived if conditions are met
Products that have already obtained approval from the competent authority of a designated country—and are lawfully available for public sale in that country—may be exempt from local laboratory testing in Argentina.
Recognised countries/regions:
- Australia
- Member States of the European Free Trade Association (EFTA)
- European Union
- United States
- Israel
- Japan
- United Kingdom
Required documentation:
A Free Sale Certificate issued by the health authority of the country of origin, demonstrating that the product is lawfully authorised and commercially available in that jurisdiction.
3. Simplified entry does not mean lax oversight—post‑market surveillance is substantially strengthened
Streamlining front‑end approvals does not imply reduced regulatory vigilance. ANMAT will significantly intensify post‑market inspections, random testing and market surveillance. Should any non‑compliance or false declarations be identified, penalties will be imposed in accordance with Argentina’s Laws 16.463 and 18.284.
IV. Practical Recommendations for Chinese Exporters
1. Confirm your product classification
Determine the exact risk class of your product under Argentina’s regulatory framework and verify whether it falls within the scope of this simplified regime. High‑risk medical devices still require the traditional registration pathway—do not misjudge the policy’s applicability.
2. Ensure your importer is properly qualified
Confirm that your Argentine partner holds a valid ANMAT authorisation and has completed the notification filing process on their end.
3. Prepare Free Sale Certificates in advance
To qualify for the local testing exemption, the certificate must originate from an official health authority in one of the recognised countries listed above.
Important note for Chinese companies: China is not currently on the exemption list. To benefit from the testing waiver, your product must first obtain market authorisation and a Free Sale Certificate from one of the recognised jurisdictions.
4. Treat declaration authenticity with the utmost seriousness
This is a sworn declaration system—the filer bears full legal responsibility for the accuracy and truthfulness of all submitted information. Ex‑post verifications will be carried out. False declarations will not be tolerated.
Should you have any questions, please feel free to contact us.