Introduction
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.
Classification of Medical and In-Vitro Devices in Argentina
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.
The classification of Medical devices under ANMAT is as follows:
| Class I |
Low Level |
| Class II |
Low to Moderate Level |
| Class III |
High to Moderate Level |
| Class IV |
High Level |
The In-Vitro Diagnostic Device is classified under ANMAT as follows:
| 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 |
Process for Medical Device Registration in Argentina
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:
- Step 1 – Classify the medical device as per the guidelines provided by ANMAT.
- Step 2 – Appoint Argentia Authorized Agent (AAR) for the registration of medical devices on the manufacturer’s behalf.
- Step 3 – The appointed Argentina Agent submits the required documents through the HELENA portal and makes the payment for the medical device registered.
- Step 4 – For Class I medical device ANMAT gives a notification number and for Class II, III & IV medical devicesANMAT provides a clearance certificate.
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.
- The documentation and data from the EU or US regulatory submissions are accepted by ANMAT as a reference in most cases.
- Due to this, the registration process of the device is streamlined because of the readily available extensive technical documentation and clinical data that shall support the safety and efficacy claims of the device.
- ANMAT considers the assessments and evaluations.
Documents Required For Medical Device Registration in Argentina
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:
- A formal statement i.e. Declaration of Conformity (Doc) confirming that your medical device complies with regulatory standards has to be submitted.
- A document having a detailed Classification of the Medical Device according to the classification mentioned by ANMAT.
- A document having details about the Medical Device Manufacturer, including contact information and other details of manufacturers have to be documented together and submitted.
- Accurate and complete labelling document as per Annex III.B of Provision 2318/2002 and Annex V of Provision 727/2013 has to be submitted.
- A document having detailed Instructions for Use (IFU) for medical devices has to be submitted.
- A whole Medical Device Technical File containing all technical details and specifications of the medical device shall be submitted.
- A Free sale or Foreign Government Certificate certifying that the device is approved for sale in another country shall be submitted to ANMAT.
Post Approval Activities after Registration is done in Argentina
After completing the registration, there are several submissions and activities that must be carried out, known as Post-Approval Activities, such as
- Manufacturers and distributors of Medical Devices shall monitor the safety and performance of their devices periodically after the approval for marketing in Argentina ANMAT. Manufacturers shall submit PSUR (Periodic Safety Update Reports) reflecting the medical device is safe to use.
- The manufacturers shall conduct regular safety data analysis and implement risk management measures.
- Revalidation of the device has to be undertaken within 30 days from the date of expiry. Manufacturers and distributors can transfer or cancel the registration request.
- Audits and inspections shall be conducted by ANMAT to assess the quality management system of the manufacturers and distributors.
Registration Timeline and Validity for Medical Devices in Argentina
Registration and Approval Process
| 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 |
Validity of Registration License
| License |
Validity Period |
| Registration License |
5 years |
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