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.