Singapore HSA Medical Device Registration
Cisema supports your full journey through medical device registration in Singapore, from determining risk class and preparing technical documentation, to securing regulatory approval and maintaining post-market compliance. As your licensed Authorized Representative (AR) or Marketing Authorization Holder (MAH) in Singapore, we manage your product registration, act as your legal interface with the authorities, and ensure your product remains compliant with the Health Products Act.
Whether you're launching a new product, registering class B, class C, or class D medical devices in Singapore, or managing submissions involving active implantable devices, standalone medical mobile applications or in-vitro diagnostics, we bring local expertise and international coordination to every step. Our services cover everything from device description and risk analysis to compliance with essential principles, alignment with overseas reference regulatory agencies, and inspection-ready quality management system support.
Singapore's Strategic Role
Singapore stands at the forefront of medical innovation in Asia, offering a stable, transparent, and internationally aligned regulatory environment. For medical device and IVD manufacturers looking to enter the high-potential Singapore market, understanding and complying with the Health Sciences Authority (HSA) requirements is essential to a success.
Our Services for Medical Device Registration in Singapore
Cisema manages the entire product registration process with the Health Sciences Authority HSA, aligning your strategy with current local and ASEAN regulatory requirements.
Regulatory Strategy & Classification
Technical Documentation & Dossier Preparation
Registration Application & Submission
Post-Approval Services
Optional Add-Ons
Authorized Representative (AR) Services in Singapore
Foreign manufacturers of IVDs and medical devices in Singapore must appoint a local authorized representative to serve as the legal applicant and regulatory liaison. Cisema is fully licensed to represent your products before the Health Sciences Authority, ensuring you meet all registration and post-market obligations.
Legal License Holder
Distributor LoAs
Regulatory Compliance
Post-Market Vigilance
Conformity Assessment Bodies Collaboration
Regulatory Strategy
Medical Device Post-Approval & Post-Market Regulatory Services in Singapore
Cisema provides ongoing post-approval and post-market regulatory support for medical devices in Singapore, helping manufacturers manage regulatory changes, safety obligations, and product lifecycle requirements.
Post-Approval Regulatory Support
Regulatory Impact Assessment
Post-Market Vigilance
FSCA & Recall Support
Quality Control Inspection Services for Medical Devices & IVDs in Singapore
Cisema’s quality control inspection services support your Singapore medical device & IVD operations by verifying compliance with HSA and global quality expectations. We ensure readiness for local distribution, regional supply, or internal audits.
Incoming Goods Inspections
In-Process Quality Monitoring
Final Product Release Inspections
Special Inspection Projects
Why Work with Cisema?
Local expertise with global reach
Our bilingual teams bridge international quality standards with local regulations
Proven track record
Over 20 years supporting market approvals and compliance in China and Asia Pacific
End-to-end solutions
From system setup to post-market surveillance, we ensure quality management and regulatory compliance throughout the product lifecycle
Industry breadth
Cross-sector expertise in life sciences, food, veterinary, consumer and industrial goods
Cisema's Singapore Office
Cisema (Singapore) Pte. Ltd.
51 Goldhill Plaza, #07-07
Singapore 308900
