The regulatory process from product design to market entry on a global scale is a complex endeavor for medical device professionals. Particularly for small and medium sized businesses it is a challenge to get an overview of the diverging market authorization pathways that differ considerably from the European Union (EU) approval pathway.
This one-day course gives participants an overview on how to plan and implement international Medical Device market access from a European corporate regulatory department perspective. The participants will be given insight on the regulatory strategy, product registration and local agent requirements in major device markets in the Americas, the Asia Pacific Region and China. Delegates will acquire key competences in international medical device regulatory and learn from hands-on industry practice.
Who should attend?
This course is addressed to people working in regulatory processes of Medical Device companies.
The course will benefit to: Directors and Managers in Quality and Regulatory Affairs departments and other departments involved in international market access.
The seminar will be beneficial to newcomers to international regulatory as well as experienced managers.
The seminar will focus on high risk non active devices.
Modules 1: Regulatory strategy
- Control market authorization assets
- Preparation steps
- Post approval consideration
Module 2: The Americas
- Canada: How to obtain Health Canada device license
- Brazil: ANVISA and INMETRO requirements
- Argentina, Mexico overview
Module 3: Asia Pacific
- Taiwan FDA (TFDA) registrations
- Singapore Health Science Authority (HSA) approvals
- Malaysia Medical Device Authority pathway
- Indonesia NA-DFC requirements
Module 4: China
- China Food and Drug Administration (CFDA) responsibilities and structure
- Laws, Regulations and Guidelines
- Approval steps and timelines for high risk products
- Practical experiences
Type of training
The Seminar will consist in interactive lectures and cases studies discussion. Delegates will have the opportunity to bring their own cases and have their regulatory strategy assessed.
At the end of the training, you will be able to:
- Develop an effective strategy to obtain product approvals on a global scale
- Acquire robust knowledge on device registration steps in the Americas, Asia Pacific and China
- Get insight on latest developments
Mr. Arkan Zwick is 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 ten years, regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device 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 graduate master degree in Law from the University of Vienna and a PhD in European Law. He has been assigned as lecturer at the University of Applied Sciences in Vienna and speaker on life cycle conferences. He is fluent speaker in English, German and French.