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Management Forum

Medical Device Regulations in Asia-Pacific Markets Training Course

As the Asia-Pacific market grows, new regulations emerge. Gain expert insights to navigate compliance and maximise opportunities.

1-2 July 2025
+ 4-5 November 2025, 3-4 March 2026 »
from £649

Need help? Enrol/reserve

Format: Live online
CPD: 7 hours for your records
Certificate of completion

Course overview

With the European medical device market now well established, the next major opportunity lies in the Asia-Pacific region. Countries like China, Hong Kong, and Singapore have introduced - or are in the process of implementing - their own medical device regulations, shaping the future of market access.

This seminar offers a deep dive into the evolving regulatory landscape, equipping you with the knowledge and practical guidance needed to navigate compliance and successfully access these high-growth markets. Learn how regulatory requirements are being interpreted and enforced, and gain the confidence to apply this understanding in your role.

Seize the opportunity to stay ahead in one of the fastest-growing medical device markets - armed with the expertise to make an impact.

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Benefits of attending

Gain an overall understanding of the medical device regulatory system in Asia
Learn the key requirements in major markets
Understand how to make product registration or launch more efficiently
Explore how to manage regulatory stakeholders in Asia

Who should attend

This seminar will be relevant to personnel from the medical device industry in the following departments:

Business development
Regulatory affairs
Registration
Quality assurance
Marketing
Manufacturing
R&D and technical affairs who would like to gain an understanding of the regulations in this region to gain access to these newly regulated markets

Enrol/reserve

This course will cover:

Day 1
Day 2

Overview of medical device regulatory in Asia

Basic regulatory framework
Criteria to get regulatory approvals
Discussion (How to make regulatory approval more efficient based on regulatory framework understanding)

Overview of medical device regulatory in Asia continued

Key stakeholders in regulatory system (ASEAN, GHWP, Regulators etc)
Discussion (How to manage key stakeholder relationships in Asia)

New medical device regulations in key markets (China, Japan, Korea, SEA, Hong Kong)

Overall system
Regulatory submission process
Product classification
General timeframe/costs
Hints and tips for success

Enrol/reserve

Jack Wong
Asia Regulatory Professionals Association (ARPA)

Six Sigma Black Belt certified by IASSC

Over 20 years of Regulatory, Quality, Clinical Trial and Pharmacovigilance experience in Asia with good knowledge in the field of Medical Devices, Pharmaceuticals, Nutritional, Consumer Healthcare and Biological products. Received awards on improving process (reduced 20% time in product launch time) and developing People (Watson Wyatt Survey to all direct reporting staff indicated that 100% of them able to contribute to their fullest ability).

Externally, playing a leading role among all the Regional Regulatory professionals in AHWP (Asian Harmonization Working Party). Developed the First Asia Regulatory Affairs Certificate course since 2007 with over 2800 students in industry, government and universities. Being the founder of ARPA (Asia Regulatory Professional Associations) since 2010 with over 3600 members. Wrote the first Asia Regulatory Book in Asia, Handbook of Medical Device Regulatory Affairs in Asia, 2nd edition now.

Qualified Auditor of ISO 13485, Japanese Regulations for Medical Devices and ISO 9000 Lead Auditor by BSI (British Standards Institution)

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

1-2 July 2025

Live online

09:00-13:00 UK (London) (UTC+01)
10:00-14:00 Paris (UTC+02)
04:00-08:00 New York (UTC-04)
Course code 15704

GBP 649 749
EUR 909 1,049
USD 1,043 1,199

Until 27 May

2 half-days of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

4-5 November 2025

Live online

09:00-13:00 UK (London) (UTC+00)
10:00-14:00 Paris (UTC+01)
04:00-08:00 New York (UTC-05)
Course code 15705

GBP 649 749
EUR 909 1,049
USD 1,043 1,199

Until 30 Sep

2 half-days of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

3-4 March 2026

Live online

09:00-13:00 UK (London) (UTC+00)
10:00-14:00 Paris (UTC+01)
04:00-08:00 New York (UTC-05)
Course code 15706

GBP 649 749
EUR 909 1,049
USD 1,043 1,199

Until 27 Jan

2 half-days of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.