Programme

2014 , November

As far as medical devices are concerned, Brazil and Mexico are the two main markets in Latin America. Every year, their populations spend several billion dollars in health care.

However, in these two countries, medical device importers must comply with heavy regulatory requirements. In order to help you throughout your export process, LNE organises a webinar on the regulation you will find in these two countries.

The webinar will be led by two experts of Mandala International. The following issues will be discussed :

BRAZIL - ANVISA (“National Health Surveillance Agency”) regulation

  • MD classification
  • Issue of MD marketing authorisations
  • Issue of the INMETRO certificate
  • Issue of the certificate of good manufacturing practice
  • Registration and product hosting methodology / Registration costs
  • Choice of distributors, traceability issues

MEXICO – COFEPRIS (“ Federal Commission for the Protection against Sanitary Risk”) regulation

  • MD Classification
  • Issue of MD marketing authorisations
  • Registration and product hosting methodology / Registration costs
  • Choice of distributors, traceability issues

Experts

Christiane BINETEurope Manager for Health sector companies

Holding a Master’s degree in International Business, Christiane BINET has been working at Mandala International for six years (since 2008). This French-Brazilian is a consultant on ANVISA/COFEPRIS regulatory affairs and specializes in the commercial support of European companies wishing to develop in Latin America (Brazil and Mexico).

Manager of the Brazilian agency, in Sao Paulo, for two years (2009 – 2011), in the context of the implementation of the subsidiary Mandala Do Brasil, she has all the knowledge and skills necessary to build up a strategy of development in Latin America, and she provides them to the Health sector companies.

Stephan FONTANELFounding Director at CroftHawk et Mandala Associés

Stephan FONTANEL, Founding Director at CroftHawk et Mandala Associés, has been supporting more than 200 companies of all sizes for 20 years. His clients are healthcare product manufacturers aiming at human beings (medical devices, medicines, sanitary products, cosmetics, agribusiness) and animals (biocides, food supplements, medicines, etc.) that want to comply with the Brazilian regulation to enter this market.

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