COUNTRIES THAT HAVE STRUCTURED REGULATORY AFFAIRS SYSTEM (FOR
IVD AND MEDICAL DEVICES) ARGENTINA BOLIVIA BRAZIL CHILE COLOMBIA
MEXICO PARAGUAY URUGUAY VENEZUELA ARGENTINA BOLIVIA BRAZIL CHILE
COLOMBIA MEXICO PARAGUAY URUGUAY VENEZUELA
Slide 3
GETTING STARTED
Slide 4
WAYS TO GET INTO THE LATIN AMERICA MARKET COMPANY LOCAL COMPANY
(SUBSIDIARY) LOCAL DISTRIBUTOR AUTHORIZED REPRESENTATIVE
Slide 5
WAYS TO GET INTO THE LATIN AMERICA MARKET Establishment of a
Subsidiary in Brazil : Advantages: the company will own the
registrations under its name. This way, the company will be free to
choose and change distributors any time that may find convenient.
Disadvantage: this process is more time consuming, once the company
has to get the state (or city) regulatory license and the federal
regulatory authorization, before submit the registration of the
products. The time to get the said licenses is about 10 to12
months. The average time to register products varies, as follows:
Medical Devices / IVD: 4~6 months. Medical Consumables and
Disposables: 4~9 months Establishment of a Subsidiary in Brazil :
Advantages: the company will own the registrations under its name.
This way, the company will be free to choose and change
distributors any time that may find convenient. Disadvantage: this
process is more time consuming, once the company has to get the
state (or city) regulatory license and the federal regulatory
authorization, before submit the registration of the products. The
time to get the said licenses is about 10 to12 months. The average
time to register products varies, as follows: Medical Devices /
IVD: 4~6 months. Medical Consumables and Disposables: 4~9
months
Slide 6
WAYS TO GET INTO THE LATIN AMERICA MARKET Registration on
behalf of Distributors name: Advantages: this option is faster than
the establishment of a subsidiary, once the distributor already has
the regulatory licenses. The timing of this operation will be only
that described below for the registration, considering that all
documents were sent to the distributor by the manufacturer: Medical
Devices / IVD: 4~6 months. Medical consumables and disposables: 4~9
months. Disadvantage: the main disadvantage is that the distributor
will hold the registrations, which (generally) are not
transferable, unless in case of incorporation, fusion or separation
of companies. If the company decides to change the distributor,
then the registrations will need to be re-make by the new
distributor. However, various distributors can hold the
registration of the same product. In this case, each one will have
its own registration number. Registration on behalf of Distributors
name: Advantages: this option is faster than the establishment of a
subsidiary, once the distributor already has the regulatory
licenses. The timing of this operation will be only that described
below for the registration, considering that all documents were
sent to the distributor by the manufacturer: Medical Devices / IVD:
4~6 months. Medical consumables and disposables: 4~9 months.
Disadvantage: the main disadvantage is that the distributor will
hold the registrations, which (generally) are not transferable,
unless in case of incorporation, fusion or separation of companies.
If the company decides to change the distributor, then the
registrations will need to be re-make by the new distributor.
However, various distributors can hold the registration of the same
product. In this case, each one will have its own registration
number.
Slide 7
WAYS TO GET INTO THE LATIN AMERICA MARKET Registration Using an
Authorized Representative (Non Commercial Holder): Advantages : the
two basic advantages of this option are that it is faster than the
establishment of a local subsidiary, once the Authorized
Representative (AR) company already has the regulatory licenses and
the timing of this operation will be only that considered to
register the products in the Local Regulatory Agencies. The other
important advantage is that the mother company can change the
distributor any time, once the holder (AR) of the registrations
will allow the distributor to import the products using the ARs
registration number. Disadvantage: the holder of the registrations
will not be the mother company, but another one with a legal
agreement to represent it in LATAM, regarding the registration of
the products only. Important: the holder of the products
registration can authorize another company (local distributors) or
final consumer (as Hospitals, Labs and Clinics) to import the
products under the registration number of the holder. This is
perfectly legal, once the holder continues to be technically and
legally responsible for the product itself. Registration Using an
Authorized Representative (Non Commercial Holder): Advantages : the
two basic advantages of this option are that it is faster than the
establishment of a local subsidiary, once the Authorized
Representative (AR) company already has the regulatory licenses and
the timing of this operation will be only that considered to
register the products in the Local Regulatory Agencies. The other
important advantage is that the mother company can change the
distributor any time, once the holder (AR) of the registrations
will allow the distributor to import the products using the ARs
registration number. Disadvantage: the holder of the registrations
will not be the mother company, but another one with a legal
agreement to represent it in LATAM, regarding the registration of
the products only. Important: the holder of the products
registration can authorize another company (local distributors) or
final consumer (as Hospitals, Labs and Clinics) to import the
products under the registration number of the holder. This is
perfectly legal, once the holder continues to be technically and
legally responsible for the product itself.
Slide 8
COMPANIES APPROVAL
Slide 9
COMPANIES APPROVAL IN LATIN AMERICA SOCIAL CONTRACT TAX ID CARD
BUILDING CONSTRUCTION OR OFFICE RENTAL BUILDING CONSTRUCTION OR
OFFICE RENTAL HIRE TECHNICAL AND LEGAL RESPONSIBLE HIRE TECHNICAL
AND LEGAL RESPONSIBLE PREPARATION & SUBMISSION OF THE BLUE
PRINTS + DOSSIER PREPARATION & SUBMISSION OF THE LOCAL LICENSE
INSPECTION PREPARATION & SUBMISSION OF THE FEDERAL
AUTHORIZATION FINAL APPROVAL BLUE PRINTS 1:100 DESCRIPTION OF THE
ACTIVITIES BASIC LIST OF PRODUCTS TO BE SOLD BLUE PRINTS 1:100
DESCRIPTION OF THE ACTIVITIES BASIC LIST OF PRODUCTS TO BE SOLD ALL
NEEDED LOCAL LICENSES
Slide 10
MEDICAL DEVICES COMPANIES DOCUMENTS REFERENCE..
Slide 11
IVD COMPANY DOCUMENTS REFERENCE..
Slide 12
PRODUCT REGISTRATION
Slide 13
MEDICAL DEVICES REGISTRATION
Slide 14
BASIC DOCUMENTS TO REGISTER MEDICAL DEVICES IN LATIN AMERICA
COMPANYS WORKING PERMIT (LATAM) FREE SALES CERTIFICATE* (WHEN
APPLICABLE) LETTER OF DISTRIBUTION* (WHEN APPLICABLE) (*)
CONSULARIZATION REQUIRED IN THE CLOSEST EMBASSY/CONSULATE OF THE
COUNTRIE WHERE THE PRODUCT WILL BE REGISTERED. GMP CERTIFICATE
(WHEN APPLICABLE) CERTIFICATE OF CONFORMITY (FOR ELECTROMEDICAL
DEVICES ONLY) INSTRUCTIONS OF USE / INSERTS / USERS MANUAL SERVICE
/ INSTALATION MANUAL LABELING PACKING COMPOSITION OF THE MEDICAL
DEVICE BASIC MANUFACTURING FLOWCHART WITH OPERATIONS MADE IN EACH
PHASE VALIDATION OF STERILIZATION PROTOCOL (WHEN APPLICABLE) PROOFS
OF SAFETY AND EFFECTIVENESS (PUBLISHED PAPERS IN SPECIALIZED
MAGAZINES OR POINTS SPECIFICALLY DESCRIBED IN LOCAL LEGISLATION)
COMPANYS WORKING PERMIT (LATAM) FREE SALES CERTIFICATE* (WHEN
APPLICABLE) LETTER OF DISTRIBUTION* (WHEN APPLICABLE) (*)
CONSULARIZATION REQUIRED IN THE CLOSEST EMBASSY/CONSULATE OF THE
COUNTRIE WHERE THE PRODUCT WILL BE REGISTERED. GMP CERTIFICATE
(WHEN APPLICABLE) CERTIFICATE OF CONFORMITY (FOR ELECTROMEDICAL
DEVICES ONLY) INSTRUCTIONS OF USE / INSERTS / USERS MANUAL SERVICE
/ INSTALATION MANUAL LABELING PACKING COMPOSITION OF THE MEDICAL
DEVICE BASIC MANUFACTURING FLOWCHART WITH OPERATIONS MADE IN EACH
PHASE VALIDATION OF STERILIZATION PROTOCOL (WHEN APPLICABLE) PROOFS
OF SAFETY AND EFFECTIVENESS (PUBLISHED PAPERS IN SPECIALIZED
MAGAZINES OR POINTS SPECIFICALLY DESCRIBED IN LOCAL
LEGISLATION)
Slide 15
EXTRA DOCUMENTS TO REGISTER MEDICAL DEVICES IN LATIN AMERICA
For Electromedical Equipments: Manufacturing Plant Audit; Tests
performed according to the IEC 60601.1 and IEC 60601.2.X; If the
Brazilian Notified Body has a Memorandum of Understanding (MOU)
with the one the certified the product in the country of origin
then test report can be accepted instead of new tests performed in
Brazil. Condoms and Surgical Gloves: Require local tests and
certification. In Vitro Diagnostic kits: The following IVD Kits may
require local tests and certification: ABO / Rh), Hepatites (B /
C), Sfilis (Treponema pallidum), HIV, Doena de Chagas (Trypanosoma
cruzi) and HTLV. For Electromedical Equipments: Manufacturing Plant
Audit; Tests performed according to the IEC 60601.1 and IEC
60601.2.X; If the Brazilian Notified Body has a Memorandum of
Understanding (MOU) with the one the certified the product in the
country of origin then test report can be accepted instead of new
tests performed in Brazil. Condoms and Surgical Gloves: Require
local tests and certification. In Vitro Diagnostic kits: The
following IVD Kits may require local tests and certification: ABO /
Rh), Hepatites (B / C), Sfilis (Treponema pallidum), HIV, Doena de
Chagas (Trypanosoma cruzi) and HTLV.
Slide 16
EXTRA DOCUMENTS TO REGISTER MEDICAL DEVICES IN LATIN AMERICA
For Orthopedic Prosthesis: Risk Analysis of the Manufacturer
according with ISO 14971, EN 93/42 EEC; All tests made to approve
the raw materials including the Certificate issued by the supplier
when applicable; All mechanical tests made according to accepted
international standards like ASTM, ISO, etc.. For example: dynamic
tests, fatigue, static tests, etc. Critical analysis of the
efficacy of the Orthopedic Prosthesis (made by the Technical
Responsible) comparing the nominal features with those obtained in
the tests and the biometrical parameters described in the
scientific literature. Everything must be compared with the
parameters set up during the design phase; For Orthopedic
Prosthesis: Risk Analysis of the Manufacturer according with ISO
14971, EN 93/42 EEC; All tests made to approve the raw materials
including the Certificate issued by the supplier when applicable;
All mechanical tests made according to accepted international
standards like ASTM, ISO, etc.. For example: dynamic tests,
fatigue, static tests, etc. Critical analysis of the efficacy of
the Orthopedic Prosthesis (made by the Technical Responsible)
comparing the nominal features with those obtained in the tests and
the biometrical parameters described in the scientific literature.
Everything must be compared with the parameters set up during the
design phase;
Slide 17
EXTRA DOCUMENTS TO REGISTER MEDICAL DEVICES IN LATIN AMERICA
Technical drawings of all components with the physical dimensions
and tolerances; Controls used by the manufacturer during the
manufacturing phase. All Quality Certificates obtained by the
Manufacturer like ISO 9001, 13485, CE Mark, 21 CFR FDA etc.; All
Quality Certificates obtained by the third party companies that
work for Manufacturer like ISO 9001, 13485, 21 CFR FDA, etc., when
applicable; Clinical studies performed with the product itself or
similar products to prove the efficacy and safety If the prosthesis
contain any material originated from cattle then Animal Health
Certificates issued by the Veterinary authority of the country of
origin of the cattle must be presented to prove that the animals
were free from spongiform encephalopathy (mad cow disease).
Slide 18
30 UP TO 150 DAYS 30 UP TO 150 DAYS CRITICAL ANALISYS
DOCUMENTATION FROM MANUFACTURER PREPARATION OF TECHNICAL DOSSIER IN
LOCAL LANGUAGE PAYMENT OF TAXES SUBMISSION IN LOCAL REGULATORY
AUTHORITIES ANALISYS BY LOCAL REGULATORY AUTHORITIES FINAL APPROVAL
CERTIFICATION or REQUIRED LOCAL TESTS CERTIFICATION or REQUIRED
LOCAL TESTS MEDICAL DEVICE REGISTRATION FLOWCHART
Slide 19
MEDICAL DEVICES REGISTRATION DOCUMENTS REFERENCE TABLE..
Slide 20
BASIC STRUCTURE OF MEDICAL DEVICES REGISTRATION DOSSIER 1.
FORMS ACCORDING TO LOCAL LEGISLATION 2. TAX PAID 3. LABELLING
ACCORDING TO LOCAL LEGISLATION 4. INSTRUCTIONS OF USE / USER MANUAL
ACCORDING TO LOCAL LEGISLATION 5. TECHNICAL REPORT 6. CERTIFICATE
OF CONFORMITY (FOR ELECTROMEDICAL DEVICES ONLY) 7. PROOFS OF
EFFICACY AND SAFETY 8. NOTARIZED COPY OF THE FREE SALES
CERTIFICATE* (WHEN APPLICABLE) 9. NOTARIZED COPY OF THE LETTER OF
DISTRIBUTION* (WHEN APPLICABLE) 10. LOCAL (LATAM) GMP CERTIFICATE
(*) DOCUMENTS MUST BE CONSULARIZED (IN THE COUNTRIE OF ORIGIN) IN
THE CLOSEST CONSULATE OF THE COUNTRIE WHERE THE PRODUCT WILL BE
CONSULARIZED 1. FORMS ACCORDING TO LOCAL LEGISLATION 2. TAX PAID 3.
LABELLING ACCORDING TO LOCAL LEGISLATION 4. INSTRUCTIONS OF USE /
USER MANUAL ACCORDING TO LOCAL LEGISLATION 5. TECHNICAL REPORT 6.
CERTIFICATE OF CONFORMITY (FOR ELECTROMEDICAL DEVICES ONLY) 7.
PROOFS OF EFFICACY AND SAFETY 8. NOTARIZED COPY OF THE FREE SALES
CERTIFICATE* (WHEN APPLICABLE) 9. NOTARIZED COPY OF THE LETTER OF
DISTRIBUTION* (WHEN APPLICABLE) 10. LOCAL (LATAM) GMP CERTIFICATE
(*) DOCUMENTS MUST BE CONSULARIZED (IN THE COUNTRIE OF ORIGIN) IN
THE CLOSEST CONSULATE OF THE COUNTRIE WHERE THE PRODUCT WILL BE
CONSULARIZED
Slide 21
IVD REGISTRATION
Slide 22
IVD REGISTRATION FLOWCHART DOCUMENTATION FROM MANUFACTURER
CRITICAL ANALISYS PREPARATION OF TECHNICAL DOSSIER IN LOCAL
LANGUAGE PAYMENT OF TAXES SUBMISSION IN LOCAL REGULATORY
AUTHORITIES ANALISYS BY LOCAL REGULATORY AUTHORITIES FINAL APPROVAL
30 UP TO 150 DAYS 30 UP TO 150 DAYS TEST IN LOCAL LAB
Slide 23
BASIC DOCUMENTS TO REGISTER IN-VITRO DIAGNOSTIC (IVD) IN LATIN
AMERICA COMPANYS WORKING PERMIT (LATAM) TECHNICAL RESPONSIBILITY
CERTIFICATE (LATAM) FREE SALES CERTIFICATE* LETTER OF DISTRIBUTION*
(*) CONSULARIZATION REQUIRED (IN THE COUNTRIE OF ORIGIN) IN THE
CLOSEST EMBASSY/CONSULATE OF THE COUNTRIE WHERE THE PRODUCT WILL BE
REGISTERED. INSTRUCTIONS OF USE / INSERTS ADITIONAL MATERIALS
REQUIRED LABELLING PACKING COMPOSITION / QUALI-QUANTI (CENTESIMAL)
FORMULA BASIC MANUFACTURING FLOWCHART WITH OPERATIONS MADE IN EACH
STEP TEST REPORT FOR CRITICAL ITEMS AS SENSITIVITY, ACCURACY,
CALIBRATION CURVES, ETC. (LOCAL TEST MAY BE REQUIRED) VALIDATION OF
STERILIZATION PROTOCOL (WHEN APPLICABLE) PROOFS OF SAFETY AND
EFFECTIVENESS COMPANYS WORKING PERMIT (LATAM) TECHNICAL
RESPONSIBILITY CERTIFICATE (LATAM) FREE SALES CERTIFICATE* LETTER
OF DISTRIBUTION* (*) CONSULARIZATION REQUIRED (IN THE COUNTRIE OF
ORIGIN) IN THE CLOSEST EMBASSY/CONSULATE OF THE COUNTRIE WHERE THE
PRODUCT WILL BE REGISTERED. INSTRUCTIONS OF USE / INSERTS ADITIONAL
MATERIALS REQUIRED LABELLING PACKING COMPOSITION / QUALI-QUANTI
(CENTESIMAL) FORMULA BASIC MANUFACTURING FLOWCHART WITH OPERATIONS
MADE IN EACH STEP TEST REPORT FOR CRITICAL ITEMS AS SENSITIVITY,
ACCURACY, CALIBRATION CURVES, ETC. (LOCAL TEST MAY BE REQUIRED)
VALIDATION OF STERILIZATION PROTOCOL (WHEN APPLICABLE) PROOFS OF
SAFETY AND EFFECTIVENESS
Slide 24
.. IVD REGISTRATION DOCUMENTS REFERENCE
Slide 25
BASIC STRUCTURE OF AN IVD REGISTRATION DOSSIER 1. FORMS
ACCORDING TO LOCAL LEGISLATION 2. TAX PAID 3. CERTIFICATE OF
TECHNICAL RESPONSIBILITY 4. LOCAL WORKING PERMIT 5. FEDERAL WORKING
PERMIT 6. LABELLING ACCORDING TO LOCAL LEGISLATION 7. INSTRUCTIONS
OF USE / USER MANUAL ACCORDING TO LOCAL LEGISLATION 8. TECHNICAL
REPORT 9. PROOFS OF EFFICACY AND SAFETY 10. NOTARIZED COPY OF THE
FREE SALES CERTIFICATE* 11. NOTARIZED COPY OF THE LETTER OF
DISTRIBUTION* 12. QUALI/QUANTI FORMULA ISSUED BY THE MANUFACTURER*
(JUST FOR IVD) 13. LOCAL (LATAM) GMP CERTIFICATE (*) DOCUMENTS MUST
BE CONSULARIZED (IN THE COUNTRIE OF ORIGIN) IN THE CLOSEST
CONSULATE OF THE COUNTRIE WHERE THE PRODUCT WILL BE CONSULARIZED 1.
FORMS ACCORDING TO LOCAL LEGISLATION 2. TAX PAID 3. CERTIFICATE OF
TECHNICAL RESPONSIBILITY 4. LOCAL WORKING PERMIT 5. FEDERAL WORKING
PERMIT 6. LABELLING ACCORDING TO LOCAL LEGISLATION 7. INSTRUCTIONS
OF USE / USER MANUAL ACCORDING TO LOCAL LEGISLATION 8. TECHNICAL
REPORT 9. PROOFS OF EFFICACY AND SAFETY 10. NOTARIZED COPY OF THE
FREE SALES CERTIFICATE* 11. NOTARIZED COPY OF THE LETTER OF
DISTRIBUTION* 12. QUALI/QUANTI FORMULA ISSUED BY THE MANUFACTURER*
(JUST FOR IVD) 13. LOCAL (LATAM) GMP CERTIFICATE (*) DOCUMENTS MUST
BE CONSULARIZED (IN THE COUNTRIE OF ORIGIN) IN THE CLOSEST
CONSULATE OF THE COUNTRIE WHERE THE PRODUCT WILL BE
CONSULARIZED
Slide 26
Technical Concepts Q&A
Slide 27
Class of Risk Class I (low risk) Class II (medium risk) Class
III (medium/high risk) Class IV (high risk)
Slide 28
DEFINITION OF MEDICAL DEVICE Product, equipment, device,
material, article or system of Medical, Odontological or
Laboratorial (Clinical Lab) use or application, used for
prevention, diagnostic, therapeutic, rehabilitation or
anti-conception that does not use pharmacological, immunological or
metabolic methods to perform its main function but may be helped in
its functions by these methods.
Slide 29
Softwares In general, softwares are classified as follows: If
they are designed only for images or data filing then they will be
considered as Class I products - Low Risk; If they give to the
operator the possibility to alter the image or the collected data,
then they will be considered as Class II - Medium Risk. Note: it is
important to re-enforce that when a product is to be used with
another higher risk class product then the first one has to be
considered in the same class of risk of the second one.
Slide 30
Softwares Requires Registration, and the Good Manufacturing
Practices (GMP) Certificate issued by ANVISA: Medical Software, not
pre-installed in medical devices/equipments, which performs image
processing, or suggests diagnostics, or is intended to be used in
surgical procedures or in ICU (intensive care unit), or directly
influences the functioning of medical devices/equipments which
require registration.
Slide 31
Used Equipment / Materials It is forbidden by LATAM legislation
to sell used products. The equipment must be refurbished by the
manufacturer or by some service company duly authorized by the
manufacturer. The product must have its registration valid. Some
materials can be re-used if re-processed properly by the
hospitals.
Slide 32
Spare Parts Once one product is registered is LATAM all its
parts and components are automatically considered as registered
also but some accessories that can be sold separately like
disposables. It is not necessary to keep the registration alive to
import spare parts for servicing but the importer has to prove that
the said product was imported during the validity of the
registration.
Slide 33
Harmonization Many norms are already harmonized in Mercosur.
Nevertheless it was expected to harmonization to be concluded and
registrations accepted among the countries since 2003. The
harmonization is delayed because of the economic situation of some
partners and also because new technologies were introduced in the
LATAM market what lead the countries to take he discussion to a
totally new different level.
Slide 34
After Sales Monitoring (Techno Vigilance) The LATAM market
(specially Mercosur) already adopted the Techno Vigilance system.
All recalls and malfunction have to be reported to the local
authorities. The Regulatory Authorities also monitor the global
market looking for problems with products that can be sold in LATAM
countries.
Slide 35
What happen when I have these changes? (1) Change the
Manufacturing Address: it is possible to update the registration.
Change of the Manufacturer: it is possible to update the
registration but it is strongly suggested that the company applies
for a new registration. It is faster and less complicated. My
company wants to add a new manufacturing site: no problem. It is
just a matter of updating the registration.
Slide 36
What happen when I have these changes? (2) When I have a major
change in my product? The company should report to the RA
authorities or submit a new registration. Can I add new products to
the approved registration? Yes, if the new product fits the
criteria of registration per family of products.
Slide 37
Family of Products What are the basic criteria for registration
as Family of Products? Same manufacturer; Same technology; Same
composition; Same use; Same side effects, warnings and special
care.
Slide 38
Is It possible to have more than one company holding the
registration of the same product? Yes, since the manufacturer
authorizes each applicant. Then each applicant will have its own
registration number.
Slide 39
TAKE INTO CONSIDERATION REGULATORY SYSTEMS IN LATAM ARE NEW
COMPARED TO EUROPE OR FDA. LOW EXPERIENCE OF THE REGULATORY
AUTHORITIES IN SOME ISSUES AND TECHNOLOGIES. SYSTEM HIGHLY
INFLUENCED BY POLITICAL FACTS / ENVIRONMENT. UNEXPECTED CHANGES MAY
OCCOUR IN THE LEGISLATION. INFLUENCE OF OTHER AUTHORITIES THAN THE
REGULATORY ONES (METROLOGY, LABOR, ETC). REGULATORY SYSTEMS IN
LATAM ARE NEW COMPARED TO EUROPE OR FDA. LOW EXPERIENCE OF THE
REGULATORY AUTHORITIES IN SOME ISSUES AND TECHNOLOGIES. SYSTEM
HIGHLY INFLUENCED BY POLITICAL FACTS / ENVIRONMENT. UNEXPECTED
CHANGES MAY OCCOUR IN THE LEGISLATION. INFLUENCE OF OTHER
AUTHORITIES THAN THE REGULATORY ONES (METROLOGY, LABOR, ETC).
Slide 40
Technical Notes in the Brazilian Health Surveillance Agency
ANVISA N 01/2012/GQUIP/GGTPS/ANVISA: for Fitness and Wellness
Products; N 02/2012/GQUIP/GGTPS/ANVISA: for Electro-Medical
Devices; N 03/2012/GQUIP/GGTPS/ANVISA: for Medical and Non Medical
Devices Definition List; 04/2012/GQUIP/GGTPS/ANVISA: Software for
Medical Devices.