THE SECOND ANNUAL MEDICAL DEVICE REGULATORY, REIMBURSEMENT AND COMPLIANCE CONGRESS ON THE CAMPUS OF HARVAD UNIVERSITY OPPORTUNITIESIN SOUTH AMERICA Eliana.

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Presentation transcript:

THE SECOND ANNUAL MEDICAL DEVICE REGULATORY, REIMBURSEMENT AND COMPLIANCE CONGRESS ON THE CAMPUS OF HARVAD UNIVERSITY OPPORTUNITIESIN SOUTH AMERICA Eliana Silva de Moraes MARCH 28-30, 2007

Marketing a Medical Device in Latin America Countries: – Routes to Market - Understanding the Latin America RA Legislation;Understanding the Latin America RA Legislation; Learning how to improve the RA environment in Latin America Countries;Learning how to improve the RA environment in Latin America Countries; Cross Culture;Cross Culture; Definition of a Medical DeviceDefinition of a Medical Device General Principles (Reasonable Safety and Effectiveness)General Principles (Reasonable Safety and Effectiveness)

Understandanding Latin America Regulatory System What should you know? 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 Argentina; Bolívia; Brazil, Belize; Caribe; Belize; Caribe; Chile; Colômbia; Costa Rica; Cuba; El Salvador; Equador; Cuba; El Salvador; Equador; Guiana Francesa; Guiana Francesa; Guiana; Guatemala; Honduras; Mexico; Honduras; Mexico; Nicaragua; Panama; Peru; Paraguay; Suriname; Urugauy; Venezulea LATIN AMERICA 21 COUNTRIES 21 COUNTRIES

How to Identify the right... Partner... Consultant... Market... Distributor... Model... Strategy... And Control your business staff! DEVELOPPING AN SPECIFIC R.A. PLAN

Legal System; Government Structure; Administrative Law System; Administrative Procedures; Legal Requirements; International Agreements Ask: what is the...

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 facilitate the RA process...

TO DO BUSINESS OUTSIDE OF YOUR COUNTRY... TO DO BUSINESS OUTSIDE OF YOUR COUNTRY... Do not wear wrong sizes.....

General Principals of Market Clearance... PREVENCION OF HARMPREVENCION OF HARM PROMOTION OF BENEFITPROMOTION OF BENEFIT Protect the public from products that are unsafe or ineffective (Reasonable Safety and Effectiveness)

LEGAL CONCEPTS BRAZIL does not make use of any pharmacological, immunological or metabolic means to perform its main function in human beings 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 that does not make use of any pharmacological, immunological or metabolic means to perform its main function in human beings 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 (!)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

The Source of Enforcement and Harmonization Process... INTERNATIONAL AGREEMENTS Mercosur Mercosur WTO – GATT WTO – GATT NAFTA NAFTA PARIS AGREEMENT... 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?

BRAZIL – ANVISA ( ARGENTINA – ANMAT ( BOLÍVIA – DINAMED ( México – Cofepris ( URUGUAY – ( CHILE – Instituto de Salud Pública ( * VENEZUELA – ( GOVERNMENT OFFICES

Thank You!