ANMAT Modernizes Import Rules for Medical Devices, Cuts Minimum Shelf Life Requirement to Six Months

In a move welcomed by the healthcare and medical technology sectors, Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has issued a new Disposition that reduces the minimum shelf life required for imported medical devices from one year to six months, effective immediately.

The change was made official through the Disposition 2565/2025 issued on April 15, 2025, which replaces Disposición N° 1655/1999, a long-standing rule that prohibited the import of medical devices with less than 12 months before expiration. The updated regulation aims to align ANMAT’s oversight with technological advances in medical devices, and to ease restrictions that stakeholders argued were limiting access to innovative products.

According to ANMAT, the review process was initiated following requests from industry representatives involved in the manufacturing, importation, and distribution of medical devices. These groups expressed concern that the original one-year requirement restricted imports and delayed the arrival of critical healthcare technologies.

Under the new framework:

• Medical devices and their accessories must now have at least six (6) months of shelf life remaining at the time of importation.

• Devices with a total approved shelf life of six months or less are exempted, provided they are not expired upon entry.

• Single-use sterile products—whether imported or locally manufactured—may not be re-sterilized, reused, or have their original packaging altered, unless specifically authorized by regulatory resolution.

• Falsifying expiration dates on packaging is explicitly prohibited and may lead to sanctions under Law No. 16.463 and possible criminal charges.

The revised policy reflects ANMAT’s intention to improve regulatory efficiency without compromising safety. The agency emphasized that shorter shelf lives should not translate into lower standards, and all products must still comply with the established quality and safety benchmarks. This update is expected to enhance the flexibility of Argentina’s healthcare supply chain, enabling hospitals and clinics to access a wider range of medical technologies while maintaining oversight to ensure patient safety. For further details, you can consult the Disposition (in Spanish) here.