SingaporeSingapore is Southeast Asia's premier life-sciences hub, offering a transparent HSA regulatory framework, world-class infrastructure, and a gateway to the broader ASEAN market. Taevas delivers end-to-end market entry support so your brand launches with sp
Select an industry to see regulatory pathways, services, and how Taevas supports your Singapore market entry.
Health Sciences Authority (HSA) — Medical Devices Branch
Singapore's medical devices market is one of the most advanced in Southeast Asia, valued at over USD 1.5 billion and growing steadily on the back of an ageing population and strong public health investment. The Health Sciences Authority regulates all medical devices under the Health Products Act, requiring product registration on the Singapore Medical Device Register (SMDR) across four risk classes. Taevas provides full-spectrum regulatory and commercial support to help international device manufacturers achieve SMDR listing and build sustainable distribution networks.
All Class B, C, and D medical devices must be registered on the Singapore Medical Device Register before they can be placed on the market. Taevas prepares and submits the full technical dossier to HSA, managing queries and timelines throughout the review process.
Low-risk Class A devices are not required to be registered but must be notified to HSA before supply. Taevas handles the notification filing and ensures labelling and post-market obligations are met from day one.
Any company importing, wholesaling, or retailing regulated health products in Singapore must hold the appropriate HSA dealer licence. Taevas acts as your local authorised representative and manages all licence applications and renewals.
HSA requires ongoing adverse event reporting, periodic safety updates, and field safety corrective actions for registered devices. Taevas operates a dedicated post-market vigilance function to keep your registration in good standing.
Taevas combines deep HSA regulatory expertise with established commercial networks across Singapore's healthcare, pharmacy, and retail sectors, giving international life-sciences brands a proven partner from first submission to sustained revenue growth.
Our Singapore team includes specialists with hands-on experience across HSA's medical devices, therapeutic products, and cosmetics branches, ensuring your dossiers are submission-ready and your timelines are protected.
Singapore is the natural first step into Southeast Asia, and Taevas leverages your Singapore registration as a platform for accelerated market entry across Thailand, Malaysia, Vietnam, and beyond.
Our pre-submission review process and established HSA relationships reduce back-and-forth query cycles, helping you achieve product registration and commercial launch faster than the industry average.
Taevas maintains active relationships with Singapore's leading medical device, pharmaceutical, and consumer health distributors, enabling rapid channel activation without the cost of building networks from scratch.
We have cultivated trusted relationships with key opinion leaders across Singapore's public healthcare clusters, academic medical centres, and specialist societies to support clinical adoption and brand credibility.
Taevas has supported numerous international life-sciences brands through successful Singapore market entry across medical devices, pharmaceuticals, personal care, and health foods, delivering measurable commercial outcomes.
Whether you are navigating your first HSA submission or scaling an established product line across Singapore's healthcare and retail channels, Taevas has the regulatory expertise and commercial networks to get you there faster.