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Two great events. Five Billion Opportunities.


MAR. 7-8, 2019

Frankfurt, Germany


MAR. 25-26, 2019

Yorba Linda, California


The Asia Pacific Device Summit is the world’s premier medical device conference for companies wishing to successfully launch products and magnify their impact in the Asia Pacific region.

The 2019 edition of the event attracts the industry's leading experts and authorities in Asia Pacific medical devices, research and regulatory affairs to discuss and debate the unique trends and challenges of our exciting, fast-paced industry.



Successfully register medical devices in theAsia Pacific region

Optimise your revenue


Manage product distribution more efficiently

Get expert insight to inform your strategy

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Gain a strong understanding of the reimbursement opportunities

Learn from experts in the field


Get best-practice tools and advice for ensuring a powerful launch

Market your products and brands effectively


Enhance regional operations

Amplify your local influence, strategic direction and cultural fit


Gain exclusive, insider information and insight into country-specific markets

In particular, the complex Chinese market


Explore ground-breaking industry research

Access the latest scientific knowledge to give your business a leg up


Share experiences, ideas and challenges 

Network with regional decision makers and thought leaders


Discuss and debate the major issues in APAC

Stay ahead of the competition and keep up-to-date with industry trends and challenges


Connect with local experts from throughout the Asia Pacific

Explore business partnering opportunities for decision makers and investors


Understand the implications of the EU-MDR within the Asia Pacific marketplace

Find out how new developments impact your organisation


Learn about drug registrations in the rigorous Australia and New Zealand markets

Ensure compliance across the region


Set your company up for a healthy, long-term operation

Get the essential tools, tips and advice your need to succeed in the Asia Pacific market

Europe Agenda



9:00 - 9:15

Opening Remarks – Cultural Challenges and Market Access

Danielle Giroud, MD Clinicals

9:15 - 10:00

Regulatory update on South Korea

10:00 - 11:15

Implementation of AMDD (Asian Medical Device Directive) - an update

Fiametta Soenardi, Sixmurs Group

11:15 - 11:45

Coffee Break

11:45 - 12:30

Taiwan Regulatory Perspectives

Brandwood CKC

12:30 - 14:00


14:00 - 14:45

Update on ASEAN Country Requirements

Fiametta Soenardi, Sixmurs Group

14:45 - 15:30

Getting your Device on the India Market

Naresh Pagdimarry, 8C Healthcare

15:30 - 16:00

Coffee Break

16:00 - 16:45

Update on Requirements for China Market Access

Brandwood CKC

16:45 - 17:00

Panel Discussion


Networking Cocktails


Registration & Coffee

9:00 - 9:30

Registration Requirements in Japan

9:30 - 10:00

Bringing your product to the market downunder - an update on Australia and New Zealand

Brandwood CKC

10:00 - 10:30

Clinical investigation opportunities in Australia

Brandwood CKC

10:30 - 11:00

Coffee Break

11:00 - 11:45

Registration process in the Middle East

11:45 - 12:30

Be Euristic, Engage in Globalization of Clinical Data

Danielle Giroud, MD Clinicals

12:30 - 14:00


14:00 - 14:45

Clinical investigation data needed for India market access and conduct clinical trials in India

Naresh Pagdimarry, 8C Healthcare

14:45 - 15:30

Conducting clinical investigations in China

Danielle Giroud, MD Clinicals

15:30 - 16:15

How to value your CE-mark in other markets

Danielle Giroud, MD Clinicals

16:15 - 17:00

Panel discussion and closing remarks

Danielle Giroud, MD Clinicals

USA Agenda


Breakfast and registration


Introduction and Welcome

Grant Bennett, Brandwood CKC


Taking your 510(k) Down Under - Australia's Reliance model of regulation.

Australia has developed a reliance model of regulation which leverages international reviews and is strong on international harmonisation. Explore TGA's streamlined Australian registration pathway for devices and IVDs already approved in US, Europe, Japan or Canada and requirements in key areas including software, UDI, clinical evidence and postmarket reporting.

Terrance (T.J.) Thiel, Brandwood CKC


China - managing the complexity

China's NMPA continues frequent and incremental updates to regulations and practice. Clinical data remain at the forefront of regulatory review, with clinical trials mandated unless formally exempted, and a very cautious opening of the door to international clinical trial data. China is following Europe's lead on postmarket reporting and placing strict requirements on local representatives for active monitoring of postmarket feedback. We take a look at the latest developments in the Middle Kingdom and why strategy with flexibility is key to success.

Jenny Lin, Brandwood CKC


Morning Tea


Secrets to Successful Medical Device Commercialisation in Australia

Understand what makes Australia an attractive market for medical devices, gain insights into some of the key considerations for market entry and how to optimise your Australian market entry strategy for success.

Kirsty Amland, Meta Medtech


Considerations for Regulatory and Commercialisation Requirements in Asia Pacific: An IOL Case Study

Japan's hybrid model combines detailed PMDA review of high risk devices with third party assessment of medium risk Class II devices. This presentation looks at the practical requirements for Japanese approvals.

Randall May, Randall May & Associates, Inc.




New Zealand rewrites the book on devices regulation

New Zealand is undertaking a root and branch reform of regulation with a complete rewrite of the 1981 Medicines Act. The new legislation introduces completely new devices regulations, which accept international reviews and toughens up postmarket requirements.

Terrance (T.J.) Thiel, Brandwood CKC


Conducting clinical investigations in China

China's formidable health care infrastructure provides many opportunities for clinical studies, but understanding the processes and local practices are essential to success.

Danielle Giroud, MD Clinicals


Afternoon Tea


Update on ASEAN countries requirements

ASEAN continues a steady expansion of the ASEAN Medical Devices Directive, with early implementation in Singapore and Malaysia now being followed by new regulations in Indonesia, Thailand and others. We look at the current progress.

Brandwood CKC


Nixon Library Tour: take some time to have a look around the library after a busy first day.

5:00 - 7:00

Networking and Cocktails


Breakfast and partner introductions

Paul Smith - SBA

Maryavis Bokal - Department of Commerce


Be euristic, engage in globalisation of clinical data – success stories

Danielle Giroud, MD Clinicals


Unlock the New Opportunities in India in 2020

India's economy is now larger than France and the United Kingdom and it has launched the world's most ambitious health insurance program covering 500 million citizens. At the same new the new medical device rules will cover ALL medical devices starting April 1, 2020. How can foreign companies thrive in this turbulent market growing at over 15 percent per year? Gunjan Bagla, a seasoned India hand, leads Amritt's India medical device practice and will share a practical overview of medical device registration in India as well as his company's tips on how to succeed in India. This is an interactive session with plenty of time for your questions.

Gunjan Bagla, Amritt Inc


Morning Tea


Australian clinical research sector update

Australia has sophisticated heath care sytems and a well defined and light touch regulation of clinical trials which make it an ideal venue for early stage studies of advanced therapies. This presentation will describe the current regulatory frameworks including TGA's pilot of clinical trial audits.

Stefan Czyniewski, Mobius Medical


Taiwan - a predictable pathway?

Taiwan's new Medical Devices Act remains stalled in parliamentary review. Meanwhile Taiwan FDA operates a unique process - driven, regulatory pathway with separate considerations of Quality Certification and product registration. It's not fast but advance planning and understanding how all the parts fit together can deliver predictable outcomes.

Jenny Lin, Brandwood CKC




Australian Reimbursement - Prosthesis Listing, Pricing and Evidence

Australia's unique reimbursement model for implantable devices continues to be in the spotlight, with continuing reforms on pricing and scope. We look at the early steps in extension of the scheme to non-implants and the evidence required for the all important Prosthesis Listing.

Sarah Griffin, Medtechnique Consulting


Combination devices - medical devices incorporating medicines

Brandwood CKC


Afternoon tea


Keynote: Global medical device regulations

With so many jurisdictions each having local requirements and different cultures and practices, clear process and planning are essential to manage a global compliance portfolio. This session describes how to develop a global strategy with regulation as a key input, and how to pull it all together from half a world away.

Grant Bennett, Brandwood CKC


Panel discussion

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Register Now.

Registrations are now open. Book in now to secure your place.