Conference Manager
April 25 - 26, 2018 - Boston,MA FL USwcsseminars
support@worldcomplianceseminars.com
Phone:347 282-5400
2 Day Workshop Product Registration and Navigating the Approval Process with Regulatory Authorities in Asia Pacific, Europe, Middle East and The Americas Description Medical devices in Brazil are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA). Brazil’s base regulations and medical device classification schemes are similar to those found in the European MDD 93/42/EEC. Commercializing your medical device for sale in Peru requires registration with DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), the country’s medical device regulator. DIGEMID currently does not have a formal classification system in place, so a device’s classification in its country of origin is usually accepted by Peruvian regulators. A four-tier classification system is currently under consideration by the Peruvian government. Areas Covered • Get assistance with medical device registration and medical device approval • Learn how to access new markets and obtain medical device approval in all the countries listed • Complete your registration in order to obtain medical device approval as efficiently as possible while realizing that some markets/countries will be more challenging • Navigate the regulatory system, achieve product registration, and access the medical market • In a group setting, review and discuss pain points, challenges and workable regulatory and compliance solutions Who will Benefit This seminar will provide an overview and in-depth snapshot of the product registration and approval process for Asia Pacific, Europe, Middle East, United States, Canada, Mexico and South America. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the registration and approval process in select countries, including: • Regulatory Affairs Management • Regulatory Affairs Specialist • Auditors • Compliance Officer • Compliance Specialist • Clinical Affairs • Quality Assurance Management Learning Objectives David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Know Your Speaker David R Dills Regulatory Affairs & Compliance Consultant David R. Dills,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. Price Seminar One Registration -$ 1395 Special Group Discount Register for Four attendees -$ 3885