If your company is selling or seeking expansion in Brazil, it´s important to stay on top of the new regulations to comply with Brazilian requirements.
This training kit will help you understand the current medical device registration requirements, import and export requirements, medical device single audit Program [MDSAP] Implementation process, reimbursement system, requirements for label claims for food, probiotics and cosmetic products, pharmacovigilance system, and health product marketing authorization requirements including documentation, approval process, labeling, advertising and post market vigilance.
You will learn the regulatory authorities’ MDSAP & EU ISO 13485 approach and the predictions for pharmaceutical, medical, cosmetic and food control in Brazil.
All Modules:
This training kit will help you understand the current medical device registration requirements, import and export requirements, medical device single audit Program [MDSAP] Implementation process, reimbursement system, requirements for label claims for food, probiotics and cosmetic products, pharmacovigilance system, and health product marketing authorization requirements including documentation, approval process, labeling, advertising and post market vigilance.
You will learn the regulatory authorities’ MDSAP & EU ISO 13485 approach and the predictions for pharmaceutical, medical, cosmetic and food control in Brazil.
All Modules:
- Module 1: Medical Device Registration - Brazil and Argentina
- Module 2: The recent changes in the Brazilian regulatory system - What are the predict for pharmaceutical, medical, cosmetic and food control in the new government?
- Module 3: Understanding the Brazilian Regulatory Environment for Medical Devices
- Module 4: Import and Export with Latin America: Argentina, Brazil and Venezuela
- Module 5: The recent changes in the Brazilian regulatory system - What are the predict for pharmaceutical, medical, cosmetic and food control in the new government?
- Module 6: Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
- Module 7: The Brazilian Reimbursement System
- Module 8: Label Claims for food, Probiotics and Cosmetic products in Brazilian Regulatory System
- Module 9: The Brazilian Pharmacovigilance System
- Module 10: US FDA, Canada Health Canada, Brazil ANVISA, Australia TGA, Japan MHLW - MDSAP & EU ISO 13485 approach
- Part 1 : Medical Device Registration - Brazil and Argentina
- Instructor: Eliana Silva de Moraes
Areas Covered in the Webinar:
- Overview of challenges and opportunities in the development of business in Brazil and Argentina
- How to develop a very good and effective regulatory affairs strategy to have success in the region
- Medical Device Approval in Brazil and Argentina
- Launching a medical device in Brazil and Argentina
- Submission, renewals and variations of the marketing authorization
Understanding how to save time and money with your RA strategy in the region
- Harmonization RA process
- Regulatory Affairs strategies
- Polices to meet the applicable regulations
Comprehensive overview of the necessary steps of Regulatory Affairs procedures in Brazil and Argentina
- Advertisement, Techno vigilance; Documentation Requirements
- Mergers & acquisitions, large and smaller transactions
The important legal issues to pay attention in order to get your product approval
- Legal department; multiple departments of relevant regulatory issues
- Registration submission, renewals and variations of the marketing authorization
- Best practices of preparation of documents and submission of application to the Agencies
- Part 2 : The recent changes in the Brazilian regulatory system - What are the predict for pharmaceutical, medical, cosmetic and food control in the new government?
- Instructor: Eliana Silva de Moraes
- Brief History of the Brazilian Health Statutory Bases
- Overview of challenges and opportunities in the development of business in Brazil
- Important steps to consider while starting your business in Brazil
- The Brazilian Agency - Anvisa: How it is organized and Works
Multiple departments of relevant regulatory issues
- Regulation of Pharmaceutical, Medical Device, Food, Cosmetic, Vet and House Hold Product
- General Overview
- Types of Products
- Product Approval in Brazil - Anvisa
- Registration submission, renewals and variations of the marketing authorization.
- How to Launch a pharmaceutical, food, cosmetic, medical device, vet and house hold products in Brazil
Administrative Procedures - Product Approval in Anvisa
- Statutory requirements for the companies
- Documents
- Timeframe
- Fees
- Overview of Preparation of documentation to submit to Anvisa;
- Understand the process to obtain marketing approval in Brazil
- Submission, renewals and variations of the marketing authorization
- Harmonization RA process
- Regulatory Affairs strategies - importation, distribution, advertising, labeling, commercialization, GMP and post-market vigilance
- Understand the health protection goals of the law; Polices to meet the applicable regulations
- Opportunity to learn about theoretical cases with exercises & examples
- Part 3 : Understanding the Brazilian Regulatory Environment for Medical Devices
- Instructor: Claudia Thereza de Lucca Mano
Areas Covered in the Webinar:
- Numbers from BR market
- Definition of medical devices
- Legal and Regulatory Basis
- Regulatory Steps
- Brazilian Registration Holder
- Company Licensing
- Classification of Risk Assessment
- Planning: Routes for Regulatory Clearance
- GMP Certification
- INMETRO Certification Requirements
- Time for submission & approval
- Government Fees for MEDICAL DEVICES
- Part 4 : Import and Export with Latin America: Argentina, Brazil and Venezuela
- Instructor: Raymond Sullivan
Areas Covered in the Webinar:
- Who can import to Latin America
- The role of the customs broker
- Documents required: commercial documents and customs documents
- What products require non-automatic import licenses
- Difference between automatic and non-automatic import licenses
- Tariffs and applicable duties
- Countervailing and antidumping duties
- Origin certification requirements
- Non-tariff barriers, other than import licenses
- Import process and its differences between Argentina, Brazil and Venezuela
- How NAFTA affects the commerce with Argentina and Brazil
- Customs inspection
- How the Trans-Pacific Partnership will reduce the cost of exporting, increase competitiveness of U.S. firms and promote fairness
- Part 5 : The recent changes in the Brazilian regulatory system - What are the predict for pharmaceutical, medical, cosmetic and food control in the new government?
- Instructor: Eliana Silva de Moraes
Areas Covered in the Webinar:
- Brief History of the Brazilian Health Statutory Bases
- Overview of challenges and opportunities in the development of business in Brazil
- Important steps to consider while starting your business in Brazil
- The Brazilian Agency - Anvisa: How it is organized and Works
Multiple departments of relevant regulatory issues
- Regulation of Pharmaceutical, Medical Device, Food, Cosmetic, Vet and House Hold Product
- General Overview
- Types of Products
- Product Approval in Brazil - Anvisa
- Registration submission, renewals and variations of the marketing authorization.
- How to Launch a pharmaceutical, food, cosmetic, medical device, vet and house hold products in Brazil
Administrative Procedures - Product Approval in Anvisa
- Statutory requirements for the companies
- Documents
- Timeframe
- Fees
- Overview of Preparation of documentation to submit to Anvisa;
- Understand the process to obtain marketing approval in Brazil
- Submission, renewals and variations of the marketing authorization
- Harmonization RA process
- Regulatory Affairs strategies - importation, distribution, advertising, labeling, commercialization, GMP and post-market vigilance
- Understand the health protection goals of the law; Polices to meet the applicable regulations
- Opportunity to learn about theoretical cases with exercises & examples
- Part 6 : Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
- Instructor: Robert J Russell
Areas Covered in the Webinar:
- Introduction and Agenda Review
- Medical Device Single Audit Program (MDSAP): Overview, History, Audit Process and Report
- U.S. FDA - Overview of Medical Device Regulations
- Device Classification, Licensing Pathways, Human Factors and Usability Studies, Medical Device GMP, Inspection Process, Device Labeling, Combination Products, License Holder Responsibilities
- (NOTE: Each country session will follow a similar format to the information above)
- Canada - Overview of Health Canada Medical Device Regulations
- Brazil - Overview of ANVISA Medical Device Regulations
- Australia - Overview of TGA Medical Device Regulations
- Japan - Overview of PMDA Medical Device Regulations
- Working with Country Regulators
- Q&A Session
- Part 7 : The Brazilian Reimbursement System
- Instructor: Eliana Silva de Moraes
Areas Covered in the Webinar:
- How does the Reimbursement System Work in Brazil.
- A comprehensive guide to the complexities of the Brazilian Reimbursement - Public and Private.
- Supporting the implementation of regulatory strategies.
- Building that the procedures and policies to meet the applicable regulations.
- Part 8 : Label Claims for food, Probiotics and Cosmetic products in Brazilian Regulatory System
- Instructor: Eliana Silva de Moraes
Areas Covered in the Webinar:
- The Brazilian Labeling Requirement for Food, Cosmetic and Probiotics.
- A comprehensive guide to the complexities of claims in the Brazilian regulatory system.
- The Brazilian Consumer Code overview for Food, Cosmetic and Probiotics claims.
- Supporting the implementation of regulatory strategies.
- Building that the procedures and policies to meet the applicable regulations.
- Part 9 : The Brazilian Pharmacovigilance System
- Instructor: Eliana Silva de Moraes
Areas Covered in the Webinar:
- Regulatory Affairs
- Pharmaceutical
- Advertisement
- Risk management
- Documentation Requirements
- Part 10 : US FDA, Canada Health Canada, Brazil ANVISA, Australia TGA, Japan MHLW - MDSAP & EU ISO 13485 approach
- Instructor: Juan M Campos
Areas Covered in the Webinar:
- Management responsibilities
- Device marketing authorization
- Facility registration
- Measurement, analysis & improvement
- Adverse events & vigilance reporting
- Design and development
- Manufacturing and service controls
- Purchasing activities
Course Provider
Robert J Russell,
