¿Can this product be considered a Medical Device in Latin America?1
“Doubt, of whatever kind, can be ended by action alone.” (Thomas Carlyle, 1795-1881)
Manufacturers of healthcare products, mainly those located outside Latin America often doubt about how their products will be considered in this Region. This question is also frequently asked by manufacturers of medical devices, especially by the time a regional business strategy is being discussed. In this article, Moeller IP Advisors highlights some actions that will give an answer to this question.
Regional Background: The Regulation of Medical Devices in Latin America
The regulation of medical devices started in the Region in the mid 90âs as a result of reforms that were carried out in the Health Sector. It was at that time that the role of the state with regards to the regulation and protection of the health of the population became more relevant in comparison with former decades.
It is also important to keep in mind that, Latin America countries including the Caribbean area are essentially medical device importing countries. It is within this context, that the health authorities of each state must guarantee the quality, safety and efficacy of products for its population, notwithstanding if the products are manufactured locally or mostly imported into their countries.
Additionally to these two regional factors, there is a third one, which takes place at an international level and that is the constantly evolving technology, where research and development enable the creation of increasingly sophisticated products.
It is this permanent evolution of new technologies that requires the continuous updating of the regulation criteria concerning these new technologies, to determine which products are safer from a quality point of view as well as the most effective for the diagnosis and / or treatment for which they have been designed and developed.
According to data provided by PAHO2, in Latin America, the countries may adopt the guidelines for a Medical Device Regulation Program based on some of the following options:
- global experience on the GHTF3 Group Guidelines or
- on the countryâs own experience where ultimately, each country will develop the guidelines in a specific way.
Should the countries follow either option to establish the guidelines for local regulation, each one must inevitably define the scope of what is a medical device as well as the classification according to its level of risk.
Clearly, health regulation is not limited by the definition or scope on what is a medical device and how it should be classified. For the purpose of this article, we will base our analysis on these two issues to explore the possible actions a foreign manufacturer can take and that will help to define a regional business strategy.
Current Medical Device Regulation in force in Latin American countries
Although almost all countries of the Region have nowadays a regulation in force making reference to what is considered a medical device, it is possible that according to the nature and use of a health product, it could be considered as a âNon Classified Productâ that falls into a “grey area” or a so called “borderline” category.
For those products that clearly fall into the definition and scope specified in the regulation of each country, the manufacturer will need to consider the risk class in which the product will be included by the time of registration as a previous step to enter in the country or market of interest.
On the contrary, those products that are within the limits of the definition of a medical device and therefore categorized as âUnclassifiedâ present some uncertainty and it will be necessary to find out if there is any way to know whether or not the health authority will have any intervention with regards to the products involved before being launched on the market.
In some countries, the health authority, specially the Medical Technology Departments which are responsible for the evaluation and approval of medical devices, accept a written query on, what is commonly referred to as, a “Non Classified Product Queryâ.
In Argentina, for example, ANMAT4 proposes the “Consultation concerning a Non Classified Product”, whose instructions can be found on its website.
Procedure for “Consultation concerning a Non Classified Product” in Argentina
In order to assess whether a product falls within the statutory definition of a medical product set out in Annex I of Resolution GMC No. 40/00, the health authority requests that the company interested in this assessment should initiate a query by enclosing the following documentation in a file :
- Intended use declared by the manufacturer of the product and clinical application
- Form and / or route of use
- Information on how the product would be supplied
- Qualitative and quantitative composition, if applicable
- Labels, instruction manuals or catalogs
- Any other information that may be deemed advisable
- Certificate of approval of the product from the county of origin (if this document is written in a foreign language a translation into Spanish must be provided)
The documentation must be signed by the legal representative of the company.
Once the evaluation process has been completed by the health authority, the Department of Medical Technology will issue a note making reference to the intervention / or no intervention with the product.
This Statement issued by the health authority to the manufacturer or the importer will be used at the time the product is imported to the country in case Argentine Customs requires the intervention of the health authority to clear Customs.
Similar procedures in other countries in Latin America
Currently the health authorities of Colombia and Venezuela apply a similar procedure, issuing a document called the âNon Intervention Letterâ that states that there is no intervention of the health authority prior to the importation of the product into the markets of these countries.
In Brazil, it is possible to perform a query via email to ANVISA5 through a company representative based in the same country.
In Mexico, COFEPRIS6 has recently reclassified 1669 products which are not considered medical devices according to the Agreement on Deregulation of Medical Devices of December 31, 2011. For this reason, the products included in this list do no longer require registration by the health authority. Also, the agreement specifies that 96 products are considered low-risk medical devices.
The regulation of health products as the result of the stateÂ´s regulatory role and its responsibility in protecting the health of the population, the low level of medical device manufacturers within the region and the permanent technological evolution of research and development on an international level are the three factors that define the current scenario of medical devices in Latin America. In this context, the uncertainty of foreign manufacturers, on how their product will be considered by the health authority is usually one of the most important issues to overcome at the time to decide a business strategy in these markets. Therefore, the chance to submit a formal query to the health authority requesting its position concerning a product in particular to find out if the manufacturer will need to proceed with the registration of a certain product in the market of interest, is a viable option that can, on the one hand, dispel this doubt and on the other hand , obtain a document that will be necessary to submit to Customs in the case, where it is required, when you have to proceed with the importation into the country.
1Authors: Marta Pentz (Head of the Regulatory Affairs Department).
2Pan American Health Organization
3Global Harmonized Task Force
4Argentine National Food & Drug Administration
5National Agency of Sanitary Surveillance
6Federal Commission for Protection against Health Risks