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.
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.
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
Who Will Benefit:
- Managers
- Regulatory Personnel
- Technical Staff
- Quality Assurance Staff
- Medical devices manufacturers/exporters
Speaker
Claudia Thereza de Lucca ManoCourse Provider
Claudia Thereza de Lucca Mano,
