1. February 201010
Medical Device
Regulation in Latin America
By Richard Morroney, RAC, CQA, JuanJose Arrieta, Adriana Belza, Margarita Biere, Graciela
Castaneda, Leonardo Funari, Sandra Gilbert, MSc, MBA, Bautista Marinaro and Ynecel Obando

2. Regulatory Focus 11
Latin America refers to a region of the Americas
where languages derived from Latin and its
Creole derivatives—Spanish, Portuguese and
French—are primarily spoken.1
For the purposes
of this article, however, “Latin America” is
defined as all of the nations located south of the
US border. Therefore, English-speaking countries
are included in our definition.
Only 18 of 41 Latin American countries
(excluding EU Outermost Regions and French
Collectivities) have implemented medical device
regulatory systems. These programs are in vari-
ous states of maturity with premarket controls as
the primary feature. In some countries, medical
device regulations are evolving while in others
the regulations are static and somewhat opaque.
Medical device regulations are driven in part by
trade agreements, primarily Mercado Común
del Sur (MERCOSUR), which seeks to create a
common market similar to the EU where goods
and services can move freely among member
countries.
The following countries do not have a
formal medical device regulatory program:
Anguilla•
Antigua and Barbuda•
Aruba•
Bahamas•
Barbados•
Belize•
British Virgin Islands•
Cayman Islands•
Dominica•
Dominican Republic•
El Salvador•
Grenada•
Guyana•
Haiti•
Montserrat•
Netherlands Antilles•
Paraguay•
Saint Kitts and Nevis•
Saint Lucia Island•
Saint Vincent and the Grenadines•
Suriname•
Trinidad and Tobago•
Turks and Caicos Islands•
Paraguay is in the early stages of developing
a medical device regulatory program. Aruba,
Curacao, Haiti and Trinidad/Tobago only
require ministry of health notification when
placing devices on the market. The British
overseas territories in Latin America (Anguilla,
British Virgin Islands, Cayman Islands, Falkland
Islands and Turks and Caicos Islands) along with
Netherlands Antilles and Aruba were invited to
form association agreements with the EU. EU
law applies to these countries only as necessary
to implement the association agreements.
The following countries regulate the manu-
facture and importation of medical devices:
Argentina•
Brazil•
Bolivia•
Chile•
Colombia•
Costa Rica•
Cuba•
Ecuador•
Guatemala•
Honduras•
Jamaica•
Mexico•
Nicaragua•
Panama•
Peru•
Puerto Rico•
Uruguay•
Venezuela•
French Guiana, Guadaloupe and Martinique are
part of France and considered European Union
Outermost Regions. EU law is applicable in these
countries. Saint Barthélemy and Saint Martin are
considered French territories and are also part of
the EU according to the Treaty of Lisbon.2
This article examines the medical device reg-
ulatory systems implemented in selected Latin
American countries and points out their similari-
ties and differences.
Overview of Regulatory System
Components
A given country’s approach to medical device
regulation can be characterized by essential
features of its regulatory system regarding the
establishment of:
national policies and the realization of•
legislation and implementation
risk-based classification systems•
market entry notification•
manufacturing controls•
premarket approval controls•
sales controls•
vigilance controls•
These features may be found in regulations gov-
erning the following stages of the medical device
lifecycle:3
Premarket: laws, regulations and techni-•
cal evaluation covering a product prior
to marketing
Marketing: regulations that govern•
distributor licensing and importer
licensing enabling countries to monitor
and control basic information (includ-
ing advertising) about stakeholders
involved in supplying the market
Postmarket (after sale): regulations for•
adverse event reporting, surveillance
studies, corrections/recalls and tracking
that countries implement to ensure the
continued safety and effectiveness of
devices after they have been sold or put
into service

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4. Regulatory Focus 13
Argentina
There are many laws and regulations that
govern all aspects of medical device develop-
ment, manufacture and supply. The regulatory
system is evolving with the revision of existing
regulations and implementation of new regula-
tions. According to Administracion Nacional de
Medicamentos, Alimentos y Tecnología Médica
(ANMAT) Disposition No. 5031/09, medical
devices on the market without a valid license
must be submitted for approval or sales will
likely be interrupted. Submission dates are as
follows: Class IV—29 January 2010; Class III—
30 July 2010; Class II—31 January 2011; and
Class I—29 July 2011.
Premarket controls include a four-tier, risk-
based classification system.4
The premarket
evaluation process is determined by risk classi-
fication. Statutory review time is 180 days for all
risk classes. The actual review timeline is approx-
imately one year. Marketing approval is valid
for five years. ANMAT Disposition No. 191/99
specifies GMP standards for medical devices and
is applicable to local and foreign manufacturers.
ANMAT Disposition No. 5267/06 requires
the listing of medical devices, manufacturers,
importers and IVD distributors in the Register
of Producers and Medical Technology Products
(RPPTM).
Postmarket controls are focused on adverse
event reporting and device recalls. Other post-
market controls such as compliance sampling
and postmarket studies are not part of the regu-
latory system.
Brazil
Many laws and regulations are in effect. These
laws and regulations are evolving and are not
transparent. Brazil is a member of MERCOSUR
and many of the laws are harmonized with the
MERCOSUR Directives.
RDC 59/00 is the only regulation not fully
enforced. It requires that Brazilian manufacturers
present a GMP certificate issued by the Agência
Nacional de Vigilância Sanitária (ANVISA). In
practice, ANVISA typically requires only local
manufacturers of Class III and IV devices to
apply for GMP certification. RDC 25/09, which
will become effective in May 2010, will change
the GMP requirements for local and foreign
manufacturers.5
In preparation for RDC 25/09,
all manufacturers that supply medical devices
to the Brazilian market must undergo a quality
system audit by ANVISA representatives prior to
May 2010. This GMP premarket approval inspec-
tion is required for new registrations, renewals
and manufacturing site changes. RDC 24/09
includes a list of Class I and II products that
require GMP audits. This will likely be a problem
as it is currently unclear whether ANVISA has
the resources to audit manufacturers worldwide.
Completion of a GMP audit takes approximately
eight to nine months.
Premarket controls include a four-tier,
risk-based classification system based on the
EU model. The premarket evaluation process is
driven by risk classification. The statutory pre-
market review timeline for all device classes is
90 days. Actual review timelines vary from six
months to a year or longer, depending upon the
Table 1. Comparison of Regulatory System Features
Premarket Controls Argentina Brazil Colombia Costa Rica Mexico Uruguay Venezuela
Legal Framework Y Y Y Y Y Y Y
Medical Device Definition Y Y Y Y Y Y N
Risk-based Classification Y Y Y Y Y N N
Premarket Evaluation Y Y Y Y Y Y Y
Manufacturing Controls Y Y Y Y Y N Y
Marketing Controls
Advertising Controls Y Y Y N Y N N
Market Entry Controls Y Y Y Y Y Y Y
Postmarket Controls
Postapproval Studies N N Y N N N N
Device Tracking N Y Y N Y Y N
Device Reporting Y Y Y Y Y Y N
Corrections/Recalls Y Y Y N Y N N

5. February 201014
device. Because the GMP audit is a requirement
for registration, the lead time to put a device
on the Brazilian market is estimated at approxi-
mately 18 months. Approval licenses are valid
for five years.
Various stakeholders are required to be
licensed. Foreign manufacturers can designate
a third party to hold product licenses on their
behalf. License holders, importers and distribu-
tors must be licensed. A qualified person who
is technically responsible for products placed
on the market must be identified. This person is
required to be licensed by state authorities.
Brazil has significant postmarket controls in
place to ensure the continued safety and efficacy
of marketed products. Although no regulations
require postmarket studies as a condition of
approval, ANVISA can require any kind of study
during premarket review. RDC 59 (June 2000)
requires device traceability for Class III and IV
products. RDC 59 (August 2008) specifies trace-
ability requirements for implantable orthopedic
devices. Medical device reporting is required
through two integrated systems: Tecnovigilância
and Hospital Sentinela. Anyone can file reports
in the Tecnovigilância system. Under the
Hospital Sentinela program, ANVISA selects
specific hospitals to report adverse event infor-
mation to the Tecnovigilância system. Recalls are
also processed through this system with direct
input from ANVISA, which monitors worldwide
recall information through the ECRI Institute.
Colombia
Colombia’s regulatory system is based in part
on the Global Harmonization Task Force (GHTF)
system. This system is characterized by a com-
plete set of regulatory controls and long review
times. The system is evolving as evidenced by
recent revisions to the laws. A recent Mutual
Recognition Agreement (MRA) with the EU will
likely yield shorter review times for Class I, IIa
and IIb devices.
Premarket controls include a four-tier, risk-
based classification system based on GHTF
guidelines. The premarket evaluation process is
determined by risk classification. Actual review
timelines range from two months to two years,
depending upon the device classification. Most
approval licenses are valid for 10 years but there
are exceptions. No local GMP standards exist but
a quality management system certificate from
the country of origin is required for imported
devices.
Various stakeholders must be licensed.
Foreign manufacturers must be identified but
need not be licensed.
The Instituto Nacional de Vigilancia
de Medicamentos y Alimentos (INVIMA),
Colombia’s national institute for food and
medicines, has implemented a complete set of
postmarket controls. INVIMA does not generally
require postmarket studies; however, current
legislation authorizes the agency to order these
studies at its discretion. Decree 4725 (2005)
and Resolution 004816 (2008) set forth require-
ments for tracking of implantable medical
devices. Medical device reporting is required by
Decree 4725, which authorizes all stakehold-
ers who become aware of adverse events to
notify INVIMA. Additionally, INVIMA requires
complete resolution and notification of any cor-
rection, removal or recall.
Costa Rica
The Costa Rican medical device regulatory sys-
tem is relatively new.6
The system incorporates
elements of the US and Canadian regulatory
systems. There is one basic regulation. Review
periods are short.
Premarket controls include a four-tier, risk-
based classification system based on Canadian
guidelines. The premarket evaluation process
consists of two stages: a review of the techni-
cal file for compliance with the submission
requirements and a technical review of product
documentation. Statutory premarket review
timelines are dependent upon device classifica-
tion. Class I and II review timelines are 15 days
for Stage 1 and 30 days for Stage 2. Class III and
IV review timelines are 30 days for both stages.
Actual review periods are between six and eight
months. Approvals are valid for five years. No
local GMP standards exist but a quality man-
agement system certificate from the country of
origin is required for imported devices
Postmarket controls are limited to medical
device reporting. Physicians, distributors and
license holders or manufacturers are required to
report adverse events.
Mexico
Mexico has many laws and regulations gov-
erning medical devices, with an emphasis on
premarket controls. The system is evolving with
revisions to existing regulations and new regu-
lations for postmarket controls in the planning
stages. Recent changes include a 24 February
2010 deadline for renewing product registrations
dated prior to 2005. The Federal Commission for
the Protection against Sanitary Risk (COFEPRIS)
is currently experiencing a significant backlog
of registrations and the review timelines for
registrations and administrative changes remain
unclear.
Premarket controls include a three-tier,
risk-based classification system. Devices are also
classified according to usage category. The rules
for classification are based on EU rules with
some modifications. The classification system
drives the premarket review process. Statutory
review times are short, with review periods of
30, 35 and 60 days specified for Class I, II and
III devices, respectively. Actual review periods
are considerably longer and currently range
from two to 12 months. No local GMP standards

6. Regulatory Focus 15
exist but a quality management system certifi-
cate from the country of origin is required for
imported devices.
COFEPRIS maintains information regarding
manufacturers, market representatives, importers
and distributors.
Postmarket controls currently include
adverse event reporting, tracking and recalls.
COFEPRIS is authorized to take samples of
marketed products and conduct testing for com-
pliance purposes.7
Uruguay
Uruguay has several laws and basic regulatory
mechanisms in each of the three stages. Decree
07/2001—transposed from a MERCOSUR
norm—specifies a risk-based classification
approach but has never been enforced. The
system is somewhat transparent. There are no
changes currently planned for the system.
No risk-based classification system is
employed. According to Decree 165/99, products
are bundled into “families” based on complexity,
e.g., sterile. The family approach is not harmo-
nized with other approaches to categorizing
products. All products that meet the definition
of a device are subject to the same premarket
review process. However, local testing of desig-
nated devices, e.g., thermometers, blood bags,
condoms and gloves, is required prior to obtain-
ing market clearance. Statutory review time is six
months for all device categories. Actual review
periods are considerably longer and currently
vary between 10 and 12 months. Approvals are
valid for five years except for devices incorpo-
rating new technology, whose approval may
be limited to one year. GMP standards are
applicable for local manufacturers only. Foreign
manufacturers must provide a quality manage-
ment system certificate from the country of
origin.
Manufacturers, distributors and importers
must register their establishments. There are dif-
ferent categories of licenses, depending upon the
scope of commercialization activity.
Uruguay’s postmarket controls are limited
to medical device reporting. Despite the lack of
official laws/regulations, regulators have pro-
mulgated guidance stating that adverse event
reporting is mandatory.
Venezuela
Venezuela’s regulatory system is opaque and is
not yet harmonized with systems of other major
markets, including MERCOSUR. Interpretation
and enforcement of basic laws are not always
clear and consistent.
No risk-based classification system is
employed. However, devices are classified
according to categories of use. As in Uruguay,
the review process is the same for all devices.
Local testing of designated devices is required
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7. February 201016
prior to obtaining market clearance. No statu-
tory review time is specified. Servicio Autonomo
de Controloria Sanitaria officials estimate three
months for the review of all device categories.
Actual review periods are considerably longer
and currently range from six to 12 months.
Registrations are generally valid for five years if
the Certificate of Free Sale (CFS) is valid for five
years and expire on the same date as the CFS or
the Certificate to Foreign Government (CFG).
No local GMP standards exist but a quality man-
agement system certificate from the country of
origin is required for imported devices.
The Ministerio del Poder Popular para la
Salud (MPPS) maintains information regarding
manufacturers, in-country market representa-
tives, importers and distributors. In-country
market representatives must have a degree in
health services or an equivalent degree.
Venezuela has not officially implemented
any postmarket controls.
Summary
The regulatory landscape for medical devices
in the Latin America countries is highly vari-
able and constantly changing. In some countries
the systems are rapidly evolving and appear
somewhat transparent and in other countries
the systems are static and opaque. Most major
markets are heavily regulated with an emphasis
on premarket controls. The concept of risk-based
classification and regulation has not yet taken
root in countries like Uruguay and Venezuela.
Hence, the review process is essentially the
same for all devices. Countries whose regulatory
systems are more advanced include market-
ing controls and limited postmarket controls
such as adverse event reporting as the primary
means to ensure continued safety after devices
have been placed on the market. The approach
among countries is quite disparate despite har-
monization efforts and the adoption of elements
from the US, Canadian and EU-based systems.
Overall, the environment appears to be one of
increasing regulation as countries like Argentina
and Brazil continue to evolve their systems with
new and revised regulations and other countries
like Bolivia, Honduras and Nicaragua, begin the
implementation of medical device regulatory
programs.
This environment represents a formidable
challenge for regulatory professionals and
medical device manufacturers who choose to do
business in the region. Few countries provide
needed medical device regulatory requirements
in English on government websites. Additionally,
important details about how regulators inter-
pret the laws and regulations for a given device
are rarely found on the Internet. Timely access
to government regulators is also problematic
without a local presence. Manufacturers must
carefully qualify their in-country representatives.
Local representatives must have a thorough
knowledge of applicable regulations and be
fluent in English to facilitate effective com-
munications with US-based manufacturers. To
ensure effective corporate governance, market
clearance data regarding how products are regu-
lated in a given country must be maintained by
regulatory professionals and corporations. The
data must be revised and validated as country
regulations evolve, thus providing an in-depth
understanding of market clearance compliance
requirements. To overcome these challenges,
manufacturers should consider employing com-
mercially available market clearance solutions to
achieve smooth market clearance operations in
what appears to be a difficult and rough regula-
tory environment.
References
1. http://en.www.wikipedia.org/wiki/Latin_america.
Accessed 02 January 10.
2. Ibid.
3. Cheng M. A Guide For The Development Of Medical Device
Regulations. Washington, DC. PAHO, 2001.
4. Administración Nacional de Medicamentos, Alimentos, y
Tecnología Médica. Disposición 2318/2002.
5. Diário Oficial da União—Seção 1, page 48, ISSN 1677-7042,
No. 96, Sexta-feira, 22 de Maio de 2009. Resolução-RDC
No- 25, de 21 de Maio dDe 2009.
6. Alcance s La Gaceta No. 80, 25 de Abril del 2008. Decretos
No. 34482-S.
7. Diario Oficial de la Federación, 17 de Abril del 2009. Ley
General De Salud, Titulo Decimo Septimo, Vigilancia
Sanitaria, Capitulo Unico, Artículo 401 Bis.
Authors
Richard Morroney, RAC, CQA, is vice president, quality and
regulatory solutions at clinivation Inc. He has more than 20
years of worldwide regulatory, quality systems and informa-
tion technology experience in the medical device industry.
He can be reached at rmorroney@clinivation.com. JuanJose
Arrieta is a regulatory affairs manager for J&M Regulatory
Affairs S.A. in Costa Rica. He has regulatory and quality sys-
tems experience in Central America and the Caribbean Region.
Arrieta can be reached at jjaacr@gmail.com. Adriana Belza
is a director for Johnson & Johnson Latin America with more
than 20 years’ experience in the medical device industry. She is
based in Uruguay where she maintains oversight for all Latin
America market clearance operations. She can be reached at
abelza@its.jnj.com. Margarita Biere and Bautista Marinaro
are pharmacists in Argentina and have extensive experience
in regulatory affairs. Their clients include Janssen, Cilag,
Johnson, Hoescht, Rhone Poulenc, Aventis, Lepetit, Sandoz and
Novartis. They can be reached at mbiere2003@yahoo.com.ar
or bautista.marinaro@gmail.com. Graciela Castaneda is gen-
eral director at Asesoría y Trámites en Regulación Sanitaria in
Mexico. Castaneda has extensive experience in medical device
manufacturing, quality systems and regulatory affairs. She can
be reached at gracielacastaneda@prodigy.net.mx. Leonardo
Funari is a technical assistant and customer relationship
specialist at Latini & Associados in Brazil. He has extensive
experience in Brazilian regulatory affairs. He can be reached
at registro@latini.com.br. Sandra Gilbert, MSc, MBA is a rep-
resentative for Latin America at the Pan American Cooperation
of Medical Equipment, the Medical Devices Andean Region
and the Subregional Commission for the Evaluation of Sanitary
Technology. She has extensive experience in regulatory/compli-
ance and quality systems. She can be reached at sanegil@att.
com. Ynecel Obando is a pharmacist and a director at Okey
Soluciones, C.A in Venezuela. She has extensive experience
with Venezuelan market clearance operations. She can be
reached at ynecel@okeysoluciones.com.ve.

8. Regulatory Focus 17
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