This webinar will discuss current medical device registration requirements in Brazil and recent regulatory changes. Topics to be discussed are Company Licensing, risk assessment, how to get regulatory clearance,GMP certification, INMETRO certification, govt fees etc.
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
Claudia De Lucca Mano,
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.