Why Should You Attend:
Brazil’s medical device industry faced a number of challenges in recent years: a complex regulatory process created long delays for approvals and a tumultuous economic and political future presented uncertainties for foreign manufacturers.
Recently ANVISA (THE BRAZILIAN HEALTH SURVEILLANCE AGENCY) has made efforts to simplify importation regulations to ease market entry for foreign manufacturers commercializing in the country. Class 1 and 2 were freed from complex regulatory procedures such as renewal of registration every 5 years, while class 3 and 4 registration can be valid for 10 years. There were also efforts to simplify GMP inspections overseas.
For companies currently selling or seeking expansion in Brazil, it´s mandatory to stay on top of the new regulations to comply with anvisa’s requirements.
In this webinar, Brazilian regulatory affairs expert, CLAUDIA THEREZA DE LUCCA MANO will examine current medical device registration requirements in Brazil and recent regulatory changes.
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
Brazil’s medical device industry faced a number of challenges in recent years: a complex regulatory process created long delays for approvals and a tumultuous economic and political future presented uncertainties for foreign manufacturers.
Recently ANVISA (THE BRAZILIAN HEALTH SURVEILLANCE AGENCY) has made efforts to simplify importation regulations to ease market entry for foreign manufacturers commercializing in the country. Class 1 and 2 were freed from complex regulatory procedures such as renewal of registration every 5 years, while class 3 and 4 registration can be valid for 10 years. There were also efforts to simplify GMP inspections overseas.
For companies currently selling or seeking expansion in Brazil, it´s mandatory to stay on top of the new regulations to comply with anvisa’s requirements.
In this webinar, Brazilian regulatory affairs expert, CLAUDIA THEREZA DE LUCCA MANO will examine current medical device registration requirements in Brazil and recent regulatory changes.
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
Speakers
With a law office in Sao Paulo, Brazil, since 1994, Claudia Thereza de Lucca Mano is a practicing attorney and consultant, who specializes on Brazilian regulatory affairs affecting health, pharmaceuticals, cosmetics, nutrition, medical devices, etc.She is registered with the Sao Paulo Brazilian Bar branch, and has a law degree from Pontificia Universidade Católica, Sao Paulo, with emphasis on Collective Rights.
Ms.Claudia is the founder of congress for pharmaceutical ingredients and prescription pharmacies Pharmashare©”. She is an expert on Brazil’s National Agency for Sanitary Surveillance (ANVISA), also a member of Committee of Regulated Markets and Sanitary Law of Brazilian Bar, and of the American Bar Association, Section of International Law, Committees of Foreign Legal Consultant and International Life Sciences and Health Law.
