Discover the course
Medical Devices Registration at an International Level
Regulatory strategy and steps for medical device market access with an eye on the Americas, the Asian pacific Region and China
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 how to plan and implement international Medical Device Registration from a European regulatory perspective. 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 Region and China.
Delegates will acquire key competences in international medical device registrations 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.
Module 1: Regulatory strategy
- How to control market authorization assets
- Preparation steps
- Post approval considerations
- The impact of MDSAP
- What I should have done differently
Module 2: The Americas
- Canada: How to obtain Health Canada device license
- Brazil: ANVISA and INMETRO requirements
- Overview on the registration in Argentina and Mexico
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
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. He is a lecturer at the University of Applied Sciences in Vienna and speaker on life cycle conferences. He is fluent in English, German and French.
This course is addressed to those working in regulatory processes of Medical Device companies: Regulatory Affairs, Clinical Operations, Quality Assurance 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 interactive lectures and case studies discussion.
Delegates will have the opportunity to bring their own cases and have their regulatory strategy assessed.
Additional information about the venue will be available soon
Early Bird: € 880,00* (until 07 May 2020)
Ordinary: € 990,00*
Freelance - Academy - Public Administration**: € 490,00*
* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Thursday, May 7, 2020
At the end of the training, you will be able to
Develop an effective strategy to obtain product approvals on a global scale
Design robust medical device registration steps in the Americas, Asia Pacific and China
Get insight on latest developments