Uruguay

Regulation name

Decree 324/999 & Decree 38/015 regulate medical devices and biologics; no traceability decree currently in place

Serialization status

No serialization mandate, basic batch tracking only

Country population

3.5 million

Alert requirement: N/A

Aggregation requirement: N/A

Track & Trace requirement: N/A

Official governing body: MSP (Ministerio de Salud Pública), via DIGEMID-equivalent systems (e.g., JND for drug registration)

Implementation deadline: Not scheduled

Serialization type / level: N/A

MAH / CMO responsibilities: Sponsors of pilot programs should report to governing bodies

Serialized product scope: N/A

Penalties for non-compliance: N/A

Repackaging rules: Regulated under labeling and GMP rules only

Market coding requirements:

MSP (Ministerio de Salud Pública), via DIGEMID-equivalent systems (e.g., JND for drug registration)