Argentina Medical Device Registration
Regulatory Authority
Direccion de Tecnologia Medica, Administracion National de Medicamentos, Alimentos yTecnologia Médico (ANMAT)
The National Institute of Medical Products (ANMAT) has implemented measures to ensure the safety and effectiveness of medical products. These include the Technovigilance Program, which evaluates adverse events after authorization and commercialization, and the “MERCOSUR Technical Regulation of Good Manufacturing Practices for Medical Products and/or Products for Diagnostic Use in Vitro.”
The Directorate of Post-Marketing Surveillance and Regulatory Actions is created within ANMAT, requiring companies holding the Medical Products Registry to implement a post-marketing monitoring system.
The ANMAT also establishes requirements for medical product registration in the Registry of Producers and Medical Technology Products.
Link for Regulatory Authority
https://www.argentina.gob.ar/anmat
Local Regulation
- DisposiciónNo 2124/11 (2011) ( https://www.argentina.gob.ar/normativa/nacional/disposici%C3%B3n-2124-2011-180851 )
- Techno Vigilance Program for Medical Devices
- ANMAT Disposición 2318/2002 Medical Device Registration (2004)
- Disposición No 727/13 (2013)
- MERCOSUR/GMC/RES. No72/98 Provision No. 9688/2019
Classification of Medical Devices
Class I,II,III,IV
Listing or Registration Requirements
- Appoint a local authorised representative in Argentina
- Manufacturer must insert all the details in the Declaration of Conformity (Only for Class I and II) document.
- Submission of the dossier for class I and II Medical Devices is done through the HELENA system.
- Start loading files for the submission; all files must be in pdf format and digitally signed by Legal Representative and Technical Director.
- If the application is approved, ANMAT will grant the medical device registration certificate.
Documents Required for Argentina Medical Device Registration
- Declaration of Conformity
- Device classification information
- Manufacturer Information
- Labelling &IFU
- Technical File
- Certificate of Free Sales or Foreign Govt. certificate
- Local Authorized Representative shall ensure that the importing medical device complies with customs regulations and procedures.
- Filing the necessary documentation, such as a commercial invoice, packing list, and shipping documents, with the Argentine customs authorities.
- Devices must be registered and approved before they are imported into Argentina
Registration Timeline
- Complete registration and approval: 12-15 months
- Application review process along with technical documents:
- Class I and II devices – 15 to 30 working days
- Class III and IV – 60 to 120 working days.
License Validity
5 years
Special Labelling Requirements
All documentation and labeling must be in Spanish.
Who should make this communication?
- Manufacturer
- Authorized Representative
When to make this communication?
Before placing a medical device into the market.
How OMC Medical can assist you with the process?
- Act as your Authorized representative
Why Choose Us?
- Working towards client satisfaction
- Cost effective solutions
- Project completion before deadline
- Quality Regulatory affairs solutions
Contact us for free consultation: sales@omcmedical.com
Frequently Asked Questions
ANMAT (National Administration of Drugs, Foods and Medical Devices) is Argentina's regulatory authority responsible for overseeing medical devices, pharmaceuticals, food products, and other regulated healthcare products. It manages medical device registration and monitors compliance with applicable regulatory requirements.
Medical device registration in Argentina is the regulatory process through which manufacturers or authorised local applicants obtain the necessary authorisation to market medical devices in the country. ANMAT oversees this process to ensure devices meet applicable safety, quality, and regulatory requirements.
The process generally involves identifying the device's risk classification, appointing an authorised local importer or representative, preparing the required technical documentation, submitting the application through the applicable ANMAT procedure, and obtaining registration authorisation before marketing the device.
Required documents may include manufacturer information, device classification details, technical documentation, a Declaration of Conformity where applicable, a Certificate of Free Sale or relevant government certificate, and Spanish-language labelling and instructions for use. Additional documents may be required depending on the device classification.
Foreign medical device manufacturers generally need an authorised local importer or representative to submit registration applications and communicate with ANMAT. The local entity must meet the applicable authorisation requirements and may act as the registration holder.
ANMAT (National Administration of Drugs, Foods and Medical Devices) is Argentina's regulatory authority responsible for overseeing medical devices, pharmaceuticals, food products, and other regulated healthcare products. It manages medical device registration and monitors compliance with applicable regulatory requirements.
Medical device registration in Argentina is the regulatory process through which manufacturers or authorised local applicants obtain the necessary authorisation to market medical devices in the country. ANMAT oversees this process to ensure devices meet applicable safety, quality, and regulatory requirements.
The process generally involves identifying the device's risk classification, appointing an authorised local importer or representative, preparing the required technical documentation, submitting the application through the applicable ANMAT procedure, and obtaining registration authorisation before marketing the device.
Required documents may include manufacturer information, device classification details, technical documentation, a Declaration of Conformity where applicable, a Certificate of Free Sale or relevant government certificate, and Spanish-language labelling and instructions for use. Additional documents may be required depending on the device classification.
Foreign medical device manufacturers generally need an authorised local importer or representative to submit registration applications and communicate with ANMAT. The local entity must meet the applicable authorisation requirements and may act as the registration holder.
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