THE SECOND ANNUAL MEDICAL DEVICE
REGULATORY,
REIMBURSEMENT AND COMPLIANCE CONGRESS
ON THE CAMPUS OF HARVAD UNIVERSITY
OPPORTUNITIES
IN
SOUTH AMERICA
Eliana Silva de Moraes
eliana@silvademoraes.com.br
MARCH 28-30, 2007
Marketing a Medical Device in
Latin America Countries:
– Routes to Market • Understanding the Latin America RA Legislation;
• Learning how to improve the RA environment in Latin
America Countries;
• Cross Culture;
• Definition of a Medical Device
• General Principles (Reasonable Safety and Effectiveness)
Understandanding Latin America Regulatory System
•What should
you know?
What is the right route?
DO YOU KNOW WHERE
YOU ARE??!!!
HOW CAN
YOU
DEVELOP
SUCESSFUL
STRATEGIES
FOR THE
LATIN
AMERICA
MARKET?
Cross culture...
•Language;
•Popular culture;
•Timing;
•Interests;
•Local Government
OFFICIAL LANGUAGE – PORTUGUESE AND SPANISH
LATIN AMERICA
21 COUNTRIES
Argentina; Bolívia; Brazil,
Belize; Caribe;
Chile; Colômbia; Costa
Rica;
Cuba; El Salvador;
Equador;
Guiana Francesa;
Guiana; Guatemala;
Honduras; Mexico;
Nicaragua; Panama; Peru;
Paraguay;
Suriname; Urugauy;
Venezulea
How to Identify the right...
•
•
•
•
•
•
Partner...
Consultant...
Market...
Distributor...
Model...
Strategy...
And Control your
business staff!
DEVELOPPING
AN SPECIFIC
R.A. PLAN
Ask: what is the...
•Legal System;
•Government Structure;
•Administrative Law System;
•Administrative Procedures;
• Legal Requirements;
•International Agreements
To facilitate the RA process...
•
•
•
•
•
Understand the legal requirements;
Identify comum documents;
Identify the main local laws;
Identify the main international agreements;
Identify the “distributor” and/or the distribution
system””;
• Identify the local consultant;
• Control local staff’;
TO DO BUSINESS OUTSIDE OF YOUR
COUNTRY...
Do not wear wrong sizes.....
General Principals of Market
Clearance...
• PREVENCION OF HARM
• PROMOTION OF BENEFIT
Protect the public from products that are
unsafe or ineffective
(Reasonable Safety and Effectiveness)
LEGAL CONCEPTS
BRAZIL
Healthcare product such as equipment, device, material, article or system for
medical, dental or laboratory use or application, intended for the purposes of
prevention, diagnosis, treatment, rehabilitation or anticonception and that
does not make use of any pharmacological, immunological or metabolic
means to perform its main function in human beings, although it may be
assisted in its functions through such means.
ARGENTINA
•
Any healthcare product such as equipment, device, material, article or
system for medical, dental or laboratory use or application intended for
prevention, diagnosis, treatment, rehabilitation or anticonception and that
does not make use of any pharmacological, immunological or metabolic
means to perform its main function in human beings, although it may be
assisted in its functions through such means.
LEGAL DEFINITIONS
URUGUAY
•
•
•
•
"Therapeutic device": any article, instrument, device or artifact including the
components, parts or accessories thereof for use in:
a) Diagnosis, treatment, attenuation or prevention of a disease, disorder or
anomalous physical state and the symptoms thereof.
b) Restoring, correcting or modifying a physiological or bodily structure function.
c) Avoiding pregnancy.
d) Caring for human beings during pregnancy or birth, or immediately thereafter.
MEXICO
Devices, accessories and instruments for a specific purposes, intended to
provide medical care, surgery or exploratory diagnostic, treatment and
rehabilitation procedures in patients, as well as those intended for biomedical
research purposes.
What does the LAW require...
Brazil, Mexico, Colombia, Venezuela, Uruguai, Chile...
Presence in the countrie (through distributor /
company);
Product registration / Certification of free sale;
Device Classification – Three levels: Class I, II and III
GMP (not for Chile*);
Technical Report;
Compliance with label requirements (local rules –
people culture)
Instruction of use;
Clinical studies of significant risk,
Regulatory Process
•
•
•
•
•
•
•
•
•
•
•
•
Application Forms.
Deed of Entitlement of the Company.
User Fees
Valid State/Municipal License.
Valid Technical Liability Certification.
Trade Mark.
Operating Instructions.
Document showing the technical responsibility - issued by the
respective entity
Product Registration in the Country of Origin / BPF Certification.
Conformity Certificate (if necessary).
Deed of Liability.
Technical Report (!)
Contractual Aspects
•
•
•
•
•
•
Guarantee of Replacement Parts
Guarantee that Technical Manuals are supplied
Technical Competence of the Bidder
Liability in the case of Technical Failure of the Equipment
Training
Guarantee Conditions
•
•
•
Guarantee of Replacement Parts
Form of Maintenance
Purchase process with commitment from the supplier/manufacturer to furnish
replacement parts/material consumed, for a minimum period of 10 years, guarantee
of the utility of the equipment, regardless of any possible manufacture discontinuity.
Imported Equipment
Maintenance with a greater or lesser agility
Negotiation with the manufacturer and/or supplier of the minimum stock levels of the
parts considered critical
•
•
•
R e gis t ra t io n o f M e dic a l D e v ic e s wit h t he P ublic H e a lt h A ut ho rit ie s in La t in A m é ric a
B ra zil M e xic o
Yes
Yes
C o py o f no t if ic a t io n o r a ut ho riza t io n is s ue d by t he public he a lt h a ut ho rit ie s
Yes
Yes
T e c hnic a l a nd s c ie nt í f ic inf o rm a t io n
Yes
Yes
T e c hnic a l a nd s c ie nt í f ic inf o rm a t io n
Yes
Yes
Ins t ruc t io ns f o r us e o r o pe ra t ing m a nua l writ t e n in S pa nis h
Yes
Yes
D e s c ript io n o f f a bric a t io n pro c e s s
Yes
Yes
D e s c ript io n o f s t ruc t ure , m a t e ria ls , pa rt s a nd f unc t io ns
Yes
Yes
D e c la ra t io n o f go o d f a bric a t io n pra c t ic e s
Yes
Yes
B iblio gra phic re f e re nc e s
Yes
Yes
R e s t ric t io n- f re e s a le c e rt if ic a t e o r e quiv a le nt is s ue d by t he public he a lt h a ut ho rit y in t he c o unt
Y ry
e s o f oY
rigin
es
P o we r o f A t t o rne y is s ue d by t he m a nuf a c t ure r
Yes
Yes
C e rt if ic a t e o f go o d f a bric a t io n pra c t ic e s is s ue d by t he public he a lt h a ut ho rit y in t he c o unt ry oYfe so riginY e s
O rigina l a na lys is c e rt if ic a t e is s ue d by t he c o m pa ny m a nuf a c t uring t he pro duc t , giv ing it s
re gis t e re d c o rpo ra t e na m e a nd s igne d by t he c he m is t s re pre s e nt ing t he f o re ign c o m pa ny
P ro o f o f qua lit y c o nt ro l
C e rt if ic a t e is s ue d by t he S upe rint e nde nc y f o r Indus t ry a nd T ra de , s t a t ing whe t he r o r no t t he
pro duc t bra nd na m e is re gis t e re d a nd whe t he r o r no t it is a v a ila ble f o r re gis t ra t io n
C o py o f re gis t ra t io n do c um e nt o f t he t e c hnic a l re pre s e nt a t iv e wit h t he re s pe c t iv e
P ro f e s s io na l B o a rd
Im po rt e r c e rt if ic a t e is s ue d by t he C ha m be r o f C o m m e rc e
Writ t e n a ut ho riza t io n is s ue d by t o t he im po rt e r by t he pro prie t o r o f t he pro duc t c o v e ring
t he a pplic a t io n f o r re gis t ra t io n wit h t he public he a lt h a ut ho rit ie s a nd pe rm is s io n t o s e ll
t he pro duc t
D o c um e nt a ry e v ide nc e o f c o rpo ra t e re gis t ra t io n a nd s it e lic e ns e s is s ue d by t he M inis t ry
f o r P ublic H e a lt h
A rge nt ina
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
C o lo m bia
Yes
No
Yes
Yes
Yes
Yes
Yes
No
No
Yes
Yes
No
Urugua y
Yes
No
Yes
Yes
Yes
Yes
Yes
No
No
Yes
Yes
No
C hile 2
No
No
No
No
No
No
Yes
No
No
No
Yes
Yes
V e ne zue la
Yes
Yes
Yes
Yes
No
No
No
No
No
Yes
Yes
Yes
Yes
No
Yes
No
No
Yes
No
Yes
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
Yes
No
No
No
Yes
No
No
Yes
No
No
No
No
No
No
Yes
No
No
Yes
No
No
Yes
Yes
No
No
No
Yes
No
No
No
No
No
Yes
No
No
No
No
No
No
Yes
Yes
No
No
No
No
Yes
Yes
C o py o f do c um e nt a t io n a ppe nde d t o t he pro duc t a t t he t im e o f s a le ( le a f le t s , ins t ruc t io ns ,
Yes
wa rra nt ie s , e t c .)
C e rt if ic a t io n o f a na lyt ic a l a nd / o r c lí nic a l e v ide nc e pro v ing t he qua lit y a nd e f f ic a c y o f t he
pro duc t c ha ra c t e ris t ic s a s de s c ribe d, unde rt a k e n in t he c o unt ry o f o rigin a nd a ppe nding
Yes
qua lit y, s t a bilit y a nd / o r a c t iv it y pro t o c o ls t ha t gua ra nt e e pro d
Q ua lit y c e rt if ic a t e a nd a na lys is pro t o c o l pro v iding s a t is f a c t o ry do c um e nt a ry pro o f o f t he
No
pro duc t c ha ra c t e ris t ic s , is s ue d by t he M inis t ry o f P ublic H e a lt h
1. N o t a rize d t hro ugh t he le ga l pro c e dure s t ipula t e d in t he c o unt ry o f o rigin, in S pa nis h o r a no t he r la ngua ge wit h t he re s pe c t iv e
t ra ns la t io n int o S pa nis h by a qua lif ie d e xpe rt t ra ns la t o r, if t he pro duc t is no t m a nuf a c t ure d by he a d o f f ic e s by he a d o f f ic
2 . N o re gis t ra t io ns re quire d f o r m e dic a l de v ic e d.
The Source of Enforcement and
Harmonization Process...
INTERNATIONAL AGREEMENTS
•
•
•
•
Mercosur
WTO – GATT
NAFTA
PARIS AGREEMENT...
Frequentely asked questions...
What are the time frame for medical equipment
registration?
Is there a premarket notification process?
Can we market the used or recycled products?
How is the clinical trial process for medical device?
How many distributor can market my product and
register it?
What is the confidential protection system?
Can we launch the product in the market without registration?
GOVERNMENT OFFICES
• BRAZIL – ANVISA (www.anvisa.org.br)
•
ARGENTINA – ANMAT (www.anmat.org.ar)
•
BOLÍVIA – DINAMED (www.sns.gov.bo/dinamed)
•
México – Cofepris (www.cofepris.gov.mx)
•
URUGUAY – (www.msp.gub.uy)
•
CHILE – Instituto de Salud Pública (www.ispch.cl) *
•
VENEZUELA – (www.msds.gov.ve/msds)
Thank You!
Eliana @silvademoraes.com.br
www.silvademoraes.com.br
www.abpvs.com.br