2025-03-01 2025-03-01 , online online, 1,490 € zzgl. MwSt. Dr. iur. Arkan Zwick https://forum-institut.de/seminar/25062502-international-medical-device-regulations/referenten/25/25_06/25062502-international-medical-device-regulations_zwick-arkan.jpg International Medical Device Regulations

This online course offers an in-depth overview of the medical device approval process in key global markets: Regulatory strategies, approval steps and timelines for global market access, with a focus on North and South America, the Asia-Pacific region and China.

Topics
  • Overview of current regulatory requirements: North and South America, China, and Asia-Pacific markets
  • Product registration and approval process
  • Key deadlines for European Manufacturers
  • How MDSAP can support regulatory compliance
  • Post-approval considerations for medical devices


Who should attend
The online seminar is aimed at professionals and managers from internationally operating medical device companies involved in regulatory affairs, clinical affairs, quality assurance, project management or international sales.

Basic knowledge of certification under the MDR for medical devices is required.
Aims and objectives
The global approval of medical devices, from product development to market entry, is a complex and demanding task, particularly for small and medium-sized enterprises. The various approval pathways, which differ significantly from EU certification, require in-depth knowledge and a strategic approach.

This seminar provides you with a comprehensive overview of the approvals, registrations and requirements for local representatives in the largest global markets. You will gain important knowledge about international approval pathways, deadlines and costs, particularly for high-risk products and medical devices in combination with medicinal products.

The seminar covers the entire process: from market access to lifecycle requirements and the impact on the quality management system.
The aim is to equip you with the necessary skills to successfully access the major product markets in North and South America, China and the Asia-Pacific region.
Your benefit

After the seminar, you will:

  • Know which approval pathways apply to medical devices in the major global markets.
  • Have learned about the differences in market access in North and South America, the Asia-Pacific region and China.
  • Be up to date with Regulatory Affairs, including in the USA, Canada, Brazil and China.

Global Medical Device Registration

International Medical Device Regulations

Registration Processes in North & South America, China and the Asia-Pacific Region

Benefits
  • Comprehensive regulatory insights
  • How to successfully access the major product markets
  • Expert-led practical guidance
  • Certified to ISO 9001 and ISO 21001 standard

Webcode 25062502

Jetzt buchen

JETZT Buchen
Referent

Dr. iur. Arkan Zwick

CROMA PHARMA GmbH, Leobendorf, AUSTRIA

Regulatory Affairs Director; Arkan Zwick, PhD iur., is Head of the Regulatory Affairs Department at CROMA PHARMA GmbH. He is responsible for the global regulatory compliance of the company and for market approvals in the EU, North America, LATAM and Asia-Pacific. He holds a doctorate in law and has been working in the legal and regulatory area of medical devices and pharmaceutical products for many years.
More information please click here.

Alles auf einen Blick

Termin

26-27/06/2025

26-27/06/2025

Zeitraum

Day 1: 9 am - 4 pm
Day 2: 9 am - 12 pm

Day 1: 9 am - 4 pm
Day 2: 9 am - 12 pm
Veranstaltungsort

online

online

Downloads
Gebühr

Veranstaltung - 1,490 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting. This online course offers an in-depth overview of the medical device approval process in key global markets: Regulatory strategies, approval steps, and timelines for global market access, with a focus on North and South America, the Asia-Pacific region, and China.

Veranstaltung - 1,490 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting. This online course offers an in-depth overview of the medical device approval process in key global markets: Regulatory strategies, approval steps, and timelines for global market access, with a focus on North and South America, the Asia-Pacific region, and China.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Verena Planitz
Conference Manager

+49 6221 500-655
v.planitz@forum-institut.de

Details

This online course offers an in-depth overview of the medical device approval process in key global markets: Regulatory strategies, approval steps and timelines for global market access, with a focus on North and South America, the Asia-Pacific region and China.

Topics

  • Overview of current regulatory requirements: North and South America, China, and Asia-Pacific markets
  • Product registration and approval process
  • Key deadlines for European Manufacturers
  • How MDSAP can support regulatory compliance
  • Post-approval considerations for medical devices


Who should attend
The online seminar is aimed at professionals and managers from internationally operating medical device companies involved in regulatory affairs, clinical affairs, quality assurance, project management or international sales.

Basic knowledge of certification under the MDR for medical devices is required.

Aims and objectives

The global approval of medical devices, from product development to market entry, is a complex and demanding task, particularly for small and medium-sized enterprises. The various approval pathways, which differ significantly from EU certification, require in-depth knowledge and a strategic approach.

This seminar provides you with a comprehensive overview of the approvals, registrations and requirements for local representatives in the largest global markets. You will gain important knowledge about international approval pathways, deadlines and costs, particularly for high-risk products and medical devices in combination with medicinal products.

The seminar covers the entire process: from market access to lifecycle requirements and the impact on the quality management system.
The aim is to equip you with the necessary skills to successfully access the major product markets in North and South America, China and the Asia-Pacific region.

Your benefit

After the seminar, you will:

  • Know which approval pathways apply to medical devices in the major global markets.
  • Have learned about the differences in market access in North and South America, the Asia-Pacific region and China.
  • Be up to date with Regulatory Affairs, including in the USA, Canada, Brazil and China.

Detailed programme

Day 1: 9 am - 4 pm
Day 2: 9 am - 12 pm

Day 1


Opening Remarks and Programme Overview
  • Introductions and Expectations

Introduction to Global Medical Device Registration
  • Global regulatory harmonisation
  • Phases of preparation, approval and lifecycle (PAL)
  • Strategic planning: Selecting the right countries and partners
  • Evaluating the availability of sufficient data

Coffee break


U.S. Medical Device Approval with the FDA
  • Structure and role of the U.S. Food and Drug Administration (FDA)
  • Navigating the 510(k) and premarket approval (PMA) pathways
  • PMA process and key timelines: From initial planning to final approval

Lunch break


Medical device approval with Health Canada (HC
  • Overview of the Canadian Medical Devices Regulations (CMDR)
  • Key guidance documents and applicable standards
  • The impact of MDSAP and practical audit preparation tips

Medical device approvals in Brazil
  • Overview of ANVISA and INMETRO: Roles and responsibilities
  • Approval requirements and procedural steps
  • Summary and audit checklist

Medical device approval in China
  • The National Medical Products Administration (NMPA): Structure and key responsibilities
  • Overview of relevant laws, regulations, and guidelines
  • Approval procedures and timelines based on risk classification
  • Case study: Class III product approval - Steps, timelines, and associated costs

End of Day 1


Day 2


Welcome to Day 2 and Open Questions


Medical device approvals in Southeast Asian markets
  • Taiwan: Regulatory procedures with the Taiwanese FDA (TFDA)
  • Singapore: Approval process with the Health Sciences Authority (HAS)
  • Malaysia: Medical device approval procedures with the Malaysian Medical Device Authority (MDA)
  • Indonesia (NA-DFC): Medical device regulatory requirements

Coffee break


Continuation of Medical Device Approvals in Southeast Asian Markets


Final Questions and Concluding Remarks


Your benefits

Access to and procedure for online events

Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.

On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.

Benefits of a FORUM Institut training course

FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.

  • Live and interactive learning on our Learning Space training platform
  • A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
  • Easy surveys with Slido
  • ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
  • A central repository for documents and media
  • Other services and apps such as Padlet and Mentimeter available directly on the platform
  • The perfect marriage of teaching methods and technology
  • High level of interactivity with plenty of opportunity for questions
  • Continuous support throughout the event to ensure the most effective learning
  • Free technical pre-meeting to start off your training on the right foot

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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