Entering the Market in Argentina

Argentina’s medical device market has continued to strengthen along with the country’s economy over the last decade. Argentina’s medical device market has increased at a rate of nearly 10% annually since the country’s 2001 crisis, and today, some Latin American countries import nearly 80% of their medical devices to Argentina.

To understand the boost in Argentina’s market, it’s important to acknowledge the country’s economic state before the increase. Argentina’s leadership turmoil and economic crisis reached its peak in December 2011 and led to these indices by the end of 2002:

  • 28% fall in Gross Domestic Product (GDP)
  • Devaluation of the currency from 1 to 4 Argentine Pesos per 1 U.S. dollar
  • 41% inflation
  • Unemployment increased from 12% in 1998 to nearly 24% in 2002
  • 57.5% rise in poverty rate
  • Nearly 24% salary decrease

Argentina is mainly an agricultural country with an industrial matrix that was strong in the 1960s. Fortunately, the increase of prices of commodities—mainly supported by soy—helped Argentina’s economy recover quickly, especially its local industry.

The manufacturing, commercialization and import of medical devices are regulated by the National Administration of Drugs, Food and Medical Technology (ANMAT). In 2002, different medical devices were regulated under different guidelines. Mercosur (Argentina, Brazil, Uruguay and Paraguay at that time) decided to change the regulatory system and unify the medical technology market under new regulations, similar to those used by countries with high surveillance. In 2002, ANMAT applied this change to Argentina products and manufacturers. It has been mandatory ever since.

Argentina´s Regulatory System

ANMAT defines a medical device as:

“a product intended for health such as a piece of equipment, an apparatus, a material, an article or system for medical, dental or laboratory use, for prevention, diagnose, treatment, rehabilitation or contraception purposes, which does not use a pharmacological, immunologic or metabolic means to perform its main function in human beings and whose function can be aided by such means.”

Prior to applying for ANMAT regulation clearance, domestic and foreign OEMs selling in Argentina have to verify if the products they manufacture or import comply with the definition of medical device.

The medical technology system is directed by two main dispositions:

  • Disposition 2319/02: Authorization of operation for manufacturers and importers of medical devices
  • Disposition 2318/02: Registration of medical devices with ANMAT

Disposition 2319/02 focuses upon regulating the operation, the quality management system (QMS), the surveillance system and plant installation of the manufacturer or importer. It requires that the manufacturer or importer implement a QMS that complies with Disposition 191/99. This Disposition is a technical regulation for Good Manufacturing Practices (GMP) similar to the international standard ISO 13485. The main difference is that the ISO 13485 requires certification and is not valid for regulatory purposes in Argentina. However, Disposition 191/99 is audited by ANMAT inspectors, and requires approval. Companies that are ISO 13485 certified can easily adjust their QMS to the local requirements.

ANMAT requires that imported medical devices ready for sale must be approved at their country of origin and have free sale under a regulatory system similar to Argentina’s regulatory system. ANMAT will check this information and decide if the importer must add additional information or perform additional testing, and ensure that the manufacturer has supplied enough information. The criteria used by ANMAT is based on safety and efficacy of the device, history of commercialization and countries where the device is still being sold, adverse events and the treatment of them. Importers may also be required to pass an ANMAT OEM plant inspection, unless they can demonstrate with objective evidence that the condition of manufacturing complies with Disp. 191/99 of GMP.

In cases wherein OEMs outsource processes to local or foreign suppliers, the OEM must have a contract signed with the supplier and this contract may be required by ANMAT. Outsourcing of a process does not release the responsibility of the OEM in the process. For this reason, the QMS required by Disposition 191/99 necessitates evaluation and qualification of the supplier, the process must be fully controlled and the products received must be fully controlled before they return to the OEM’s production system.

Once the OEM has been inspected and approved by ANMAT, two certificates are issued: the first has no expiration date and is a certificate of authorization for manufacturing or importing medical products declared by the company. The second is a GMP certificate with five years of validity.

Once an OEM has authorization and its GMP certificate, it can proceed to ask ANMAT to register a family of medical device products that are clinically, technically and biologically compatible. The requirements are expressed in Disposition 2318/02. The official forms are different depending on the risk class of the product and whether the device is manufactured in Argentina or imported. This disposition acts as a premarket approval (PMA) similar to FDA’s—Argentina does not have a 510(k) system for premarket notification, and all registries are submitted to premarket approval no matter their class (Class I devices must fill a Declaration of Conformity)—and gives way for the manufacturer to make and compile the product registry, rules to classify the product (Class I, II, III and IV) definitions, requirements to fulfill for the labeling and instructions for use (IFU), description and performance of the product through a technical report, tests to demonstrate product safety and effectiveness and flowchart of the manufacturing system. For Class III and IV, the OEM must also add a risk management analysis, including the final report and a clinical revision report signed by a professional that will use the product (an orthopaedic surgeon, in the case of a hip implant). The risk analysis must be performed according to the ISO 14971 standard.

ANMAT has 180 days to approve a device as defined in Disposition 2318/02. That time may be stopped if ANMAT asks the OEM to present additional information, and continues when the OEM presents the information. Once ANMAT clears the OEM for registration and free sale of the device, it can commercialize its product. The registry is valid for five years.

Argentina´s Industrial System

Since the 2001 crisis, Argentina’s industrial growth has increased at a mean of 7.7% annually. This has led to technological growth in computer numerical control machine tools, robotics, control and measuring systems and computers and software. This also was reinforced by technical qualification of workers following the fall of unemployment from 24% in 2001 to nearly 6% today, though there is still a high rate of informal employment of nearly 30%.

Two important points of note:

  • Argentina is actually experiencing increased inflation rates with a controlled increase of the U.S. exchange rate. The result of this is an increase of prices of consumer goods in U.S. dollar terms.
  • Since the beginning of 2012, the government has set several restrictions on imported goods and raw materials (including medical devices) and transfer of earnings for companies with their headquarters abroad. Importing requires previous authorization from the Secretary of Commerce. Most companies that important products to Argentina need to fill out a DJAI (Anticipated Sworn Declaration for Import).The restrictions are established by product through an international customs nomenclature. The process is not complicated, but can turn bureaucratic.

These two points switched on a yellow light to the industrial system, but despite this, the actual industrial matrix of Argentina is strong and well-qualified to manufacture medical devices, at the same quality level of OEMs in developed countries.


Ing. Pablo Carbonell is an industrial engineer and Chief of Quality Engineering and Regulatory Affairs of IMPLANTES FICO SRL. He has more than 30 years of experience with orthopaedic surgical implants and joint replacement. Carbonell is also a consultant in risk analysis of medical devices, quality management system implementation, safety and efficacy of medical devices and regulatory affairs of products, and is a professor of Endoprosthesis at Universidad Nacional de San Martin in Buenos Aires. He can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..

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