The regulatory process from product design to market entry on a global scale is a challenging endeavor for medical technology companies. Particularly for small and medium sized medtech businesses it is a challenge to get an overview of the diverging device market authorization paths that differ considerably from the European Union (EU) approval.
This course gives participants an overview how to plan and implement international Medical Device Registration from a European regulatory perspective with a focus on high risk devices including device drug combination medical devices. The participants will be given insight on the regulatory and quality system strategy, product registration and local agent requirements in major device markets in the Americas, the Asia Pacific and China.
Delegates will acquire competences in international medical device registration pathways, timelines and costs and learn from hands-on industry practice. The course will cover both initial market access as well as life cycle requirements and quality system implications.
Introduction: How to control market authorization assets
Preparation & post approval considerations
Impact of the Medical Device Single Audit Program – MDSAP
Canadian Medical Devices Regulations
Brazil: ANVISA and INMETRO requirements and market access steps
Overview on registrations pathway in Argentina and Mexico
MODULE 2 China
National Medical Products Administration (NMPA) responsibilities and structure
Overview on Laws, Regulations and Guidelines
Approval steps and timelines according to risk class
Practical experiences. What I should have done differently
The Asia Pacific
Taiwan FDA (TFDA) registrations
Singapore Health Science Authority (HSA) approvals
Malaysia Medical Device Authority pathway
Indonesia NA-DFC requirements
This course is addressed to professionals in MedTech companies with an international market perspective: Regulatory Affairs; Clinical Operations, Quality Assurance, Project Managers, Sales and other departments involved in international market access.
No previous experience in international medical devices registration is needed. Experience with medical devices regulatory processes in Europe may be helpful.
The training will consist in lectures, case studies discussion and Q&A sessions.
Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria
Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharmaceutical, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than eleven years of regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device, combi products and cosmetic compliance projects as well as in house legal advice for contract management, merger and acquisition, and intellectual property projects. He is responsible for the company’s regulatory compliance in the EU working with several notified bodies and for global market authorizations in the Americas and Asia-Pacific.Arkan has a master’s degree in Law from the University of Vienna and a PhD in European Law. His expertise includes in house legal and regulatory consulting as well as lecturing at the University of Applied Sciences in Vienna and scientific board member and speaker on life cycle conferences and trainings. He is fluent in English, German and French.
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