Understanding the Brazilian Regulatory Environment for Medical Devices
Instructor:
Claudia Thereza de Lucca Mano
Product ID: 705721
- Duration: 60 Min
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
Claudia De Lucca Mano
Founder, Pharma Share
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.
Refund Policy
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
