Are You Looking For Medical Devices Certifications?
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In Argentina, the regulation of medical devices falls under the jurisdiction of the National Administration of Drugs, Food, and Medical Devices also known as “Argentine Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) in Spanish, which operates as a decentralized body under the Ministry of Health.
The ANMAT is responsible for medical device registration in Argentina and its supervision. The regulations applicable to register the medical device in Argentina are Disposition 2318/2002, and Disposition 727/2013.
As per ANMAT guidelines, the classification is based on the risk level involved in medical devices, and for In-vitro devices, it is based on diagnosis.
| Class I | Low Level |
| Class II | Low to Moderate Level |
| Class III | High to Moderate Level |
| Class IV | High Level |
| Class A | Non-Infectious or Non-Communicable diseases |
| Class B | Infectious diseases, except those in Class C |
| Class C | Sexually Transmitted Infectious Diseases, or those transmitted by Blood or Blood Derivatives, including Blood Group Identification. |
| Class D | For self-assessment |
The process of Medical Device Registration in Argentina involves various steps to be followed. A step-by-step registration process as per ANMAT is mentioned below:
If the medical device under registration in Argentina is already EU/US-approved, then it gets qualified as an expedited medical device, since the registration process is simplified.
While preparing for medical device registration in Argentina, you’ll need to gather and submit several key documents (A list of all documents is mentioned below). As per ANMAT guidelines, all the required documents shall be submitted in Spanish language.
Here are the essential documents:
After completing the registration, there are several submissions and activities that must be carried out, known as Post-Approval Activities, such as
| Device Class | Application Review Time | Complete Registration Timeline |
|---|---|---|
| Class I and II | Approximately 15 to 30 working days | Approximately 60 to 120 working days |
| Class III and IV | Approximately 60 to 120 working days | Usually about 12 to 15 months |
| License | Validity Period |
|---|---|
| Registration License | 5 years |
At Maven Profcon Services LLP, we specialize in regulatory consultancy for medical device manufacturers, catering to various needs such as Quality Management Systems (QMS), ISO 13485 certification, USFDA 510k submissions, MDSAP, EU MDR compliance, and Country Registrations in more than 150+ countries.
Our comprehensive services ensure a streamlined approach to regulatory compliance, offering you everything you need in one place for successful medical device registration in Argentina.
For Medical Devices Registration in Argentina, contact us at enquiry@mavenprofserv.com or call +91-7490017774 / +91 7940026222. We’re here to assist you with registering your medical device in Argentina.
December 3rd, 2024
December 3rd, 2024
