Simplifying Regulatory Compliance & APAC Market Access
From HSA approval to regional distribution, we help medical device and therapeutic innovators navigate regulations, accelerate submissions, and deliver products across Asia-Pacific safely and efficiently.
Core Services
Comprehensive regulatory solutions tailored for medical device manufacturers, pharmaceutical companies, and healthcare innovators entering APAC markets.
Medical Device Registration
Class A–D risk classification, GN-15/16 compliance, MEDICS portal submissions, and QMS implementation for Singapore HSA approval.
- Risk Classification
- GN-15/16 Compliance
- MEDICS Portal
- QMS Implementation
Therapeutic Products
HPA alignment, GMP compliance, labelling requirements, and advertising guidelines for pharmaceutical and biological products.
- HPA Alignment
- GMP Compliance
- Labelling Standards
- Advertising Guidelines
Post-Market Vigilance
Ongoing vigilance, variation management, APAC scaling support, and continuous compliance assurance.
- AE Reporting
- Surveillance Systems
- Risk Management
- Compliance Monitoring
APAC Sales and Distribution
Secure storage, logistics, and sales support for medical devices and digital health products across APAC.
- Secure Warehousing
- Regional Logistics
- Sales Support
- Order Fulfillment
AI / SaMD Solutions
Software as Medical Device classification, lifecycle management, cybersecurity compliance, and algorithm validation.
- SaMD Classification
- Lifecycle Management
- Cybersecurity
- Algorithm Validation
Regulatory Consulting
Comprehensive audits, strategic planning, regulatory training, and ongoing advisory services for compliance excellence.
- Regulatory Audits
- Strategic Planning
- Training Programs
- Advisory Services
About Deyun Regulatory Solutions
Our Mission
To enable safe, compliant market access for innovative healthcare solutions across Asia-Pacific. We bridge the gap between regulatory complexity and business success, ensuring your products reach patients safely and efficiently.
Our Values
Integrity
Maintaining the highest ethical standards in all regulatory processes and client relationships.
Expertise
Deep regulatory knowledge backed by years of experience in HSA compliance and APAC markets.
Commitment
Dedicated to your success with personalized attention and unwavering support throughout your journey.
Innovation
Embracing cutting-edge regulatory approaches and technologies to streamline compliance processes.
Our Process
A systematic approach to regulatory success, from initial consultation to post-market compliance and APAC expansion.
Consultation
Comprehensive assessment of your technology, risk classification, and optimal HSA route (Full/Abridged/Expedited pathway).
- Technology Assessment
- Risk Classification
- Pathway Selection
- Timeline Planning
Documentation
Building comprehensive dossiers, technical files, and ensuring SHARE portal readiness for seamless submissions.
- Dossier Preparation
- Technical Files
- SHARE Portal Setup
- Quality Documentation
Submission
Direct liaison with HSA, proactive query monitoring, and comprehensive licensing management throughout the process.
- HSA Liaison
- Query Management
- Status Monitoring
- License Processing
Post-Market
Ongoing vigilance, variation management, APAC scaling support, and continuous compliance assurance.
- Vigilance Systems
- Variation Management
- APAC Expansion
- Compliance Continuity
Resources & Insights
Stay updated with the latest regulatory developments, guidelines, and best practices for HSA compliance and APAC market access.
Latest Updates
How to Launch Your Medical Device or Health Product in Singapore: A Step-by-Step Guide
Complete guide for international manufacturers entering Singapore's healthcare market with HSA compliance.
GN-16 Quality Management System Requirements
Comprehensive guide to QMS implementation for medical device manufacturers under GN-16.
GN-15 Medical Device Classification Updates
Latest updates on HSA's Guidance Note 15 for medical device risk classification and regulatory pathways.
Frequently Asked Questions
What are the different HSA approval pathways?
HSA offers four main registration routes: Full, Abridged, Expedited, and Immediate, depending on device risk, novelty, and prior approvals. Choosing the correct pathway ensures faster review and smoother market entry.
What are the adverse event reporting timelines in Singapore?
HSA requires death or serious deterioration to be reported within 48 hours, and all other serious adverse events within 15 calendar days. Timely reporting is mandatory to maintain regulatory compliance and market access.
How are medical devices classified in Singapore?
Medical devices are classified under GN-13 into Class A (low risk), B (low–moderate), C (moderate–high), or D (high risk) based on intended use, invasiveness, and duration of contact. Correct classification determines the required documentation, regulatory pathway, and risk management obligations.
What qualifies as Software as a Medical Device (SaMD)?
Software is considered SaMD if it performs medical functions independently, supports medical decisions, or directly influences patient care without hardware integration. SaMD products must comply with HSA regulations, including risk classification per GN-13, registration requirements per GN-15, and software-specific guidance under GL-04/GL-07 for validation, risk management, and lifecycle management.
Get in Touch
Ready to navigate HSA compliance and accelerate your APAC market entry? Let's discuss your regulatory strategy and pathway to success.
Singapore Office
Deyun Regulatory Solutions
60 Paya Lebar Road
#07-54 Paya Lebar Square
Singapore 409051
Phone
+65 8899 1030
contact@deyunsolutions.com
Business Hours
Monday - Friday: 9:00 AM - 6:00 PM SGT Saturday: 9:00 AM - 1:00 PM SGT