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.
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
Certifications:
- CPD: 7 hours for your records
- Certificate of completion
Course Content
Day 1
Overview of medical device regulations 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 regulations in Asia continued
- Key stakeholders in the regulatory system (ASEAN, GHWP, Regulators etc).
- Discussion (How to manage key stakeholder relationships in Asia)
Day 2
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
Course Provider
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)
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
