Profile

Dylan Tan

Lead, Asia-Pacific Regulatory Partnerships · NUS Enterprise
MedTech Commercialization Working Group

Every promising medtech innovation deserves a clear, predictable regulatory path to the patients who need it across Asia-Pacific.

NUS ENTERPRISE
MEDTECH WG
SINGAPORE
About

I lead regulatory partnerships across Asia-Pacific at NUS Enterprise, helping medtech innovations move from the lab through the region's regulatory pathways toward real commercialization.

My focus is global regulatory harmonization, particularly the evolution of China's medical device registration and quality compliance framework — and the ongoing efforts of organizations like AdvaMed to advance harmonization across borders.

Focus

Regulation, quality, and harmonization

NMPA · Device Registration Regulations

China Registration Pathways

Mapping registration strategy for the China market as classification and review requirements evolve.

ISO 13485:2016

Quality Management Compliance

Consistent QMS implementation across markets, without duplicating the cost of building and auditing.

ISO 14971 · Risk Management

Post-Market Surveillance

Risk management across the product lifecycle, and how post-market data feeds back into compliance.

IMDRF · Cross-Border Coordination

Harmonization & Partnerships

Ongoing dialogue with regulators and associations, including AdvaMed, toward regulatory convergence.

Harmonization

One registration file, multiple markets

NMPA
ChinaDevice registration
HSA
SingaporeRegional hub
TGA
AustraliaMutual recognition
PMDA
JapanReview liaison
IMDRF
GlobalStandards alignment
ADV
AdvaMedIndustry partner