Obtaining a medical device import licence in Singapore involves navigating the Health Sciences Authority (HSA)’s structured regulatory framework. All importers must be licensed by HSA, and every medical device must be registered in the Medical Device Information Communication System (MEDICS) according to its risk classification from Class A (low risk) to Class D (high risk). […]
GDPMDS certification ensures safe, compliant medical device distribution, protecting quality and patient safety.
When entering international markets, companies often face regulatory hurdles that can slow down their expansion. Independent licence holding allows foreign manufacturers to appoint a local company to manage product registrations and import licences. This enables them to sell directly to multiple distributors whilst maintaining control over their business strategy. Local authorised representatives act as intermediaries […]