Singapore Medical Device Registration

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.

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.