About

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, software medical devices and in-vitro diagnostics. 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.

MODULE 1
Regulatory strategy & the Americas

  • 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
  • Q&A

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
  • Q&A

The Asia Pacific

  • Taiwan FDA (TFDA) registrations
  • Singapore Health Science Authority (HSA) approvals
  • Malaysia Medical Device Authority pathway
  • Indonesia NA-DFC requirements
  • Q&A

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.

Participant experience
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.

Lecturers
Arkan Zwick
Info

Arkan Zwick

Corporate Director Regulatory Affairs at Croma Pharma

Arkan has a master’s degree in law and PhD in European law. His role includes regulatory strategy, advice and advocacy for drug, devices, and combinations product projects as well as in house legal advice for contract management and due diligence projects. His responsibility includes global regulatory compliance and regulatory market access in the EU, Americas and Asia-Pacific for devices and combination products in ophthalmology, orthopedic and aesthetic medicine. Arkan is lecturer and trainer at the University of Applied Sciences in Lower Austria and on life cycle conferences and trainings. He is fluent in English, German, French and Turkish.


Online Training – 2 modules

20 April 2023      9:30 am – 12:30 pm CEST
21 April 2023      9:30 am – 12:30 pm CEST

After the registration, you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 660,00* (until 05 April 2023)

Ordinary: € 850,00*

Freelance – Academy – Public Administration**: € 430,00*

* for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Printable Version
At the end of the training, you will be able to
Risultato atteso
Develop an effective strategy to obtain product approvals on a global scale
Risultato atteso
Design robust medical device registration steps in the Americas, Asia Pacific and China
Risultato atteso
Get insight on latest developments

<p>Online interactive training on Zoom platform.</p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform.

LS Academy will provide the access link to the virtual platform a few days before the training.

<p>Online interactive training on Zoom platform.</p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>