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). […]
On 22 August 2025, the Health Sciences Authority (HSA) of Singapore and the Medical Device Authority (MDA) of Malaysia signed an MOU to launch a Medical Device Regulatory Reliance Pilot. What this means: Running from 1 Sept 2025 to 28 Feb 2026, this pilot is a significant step towards regulatory convergence and smoother market access across borders. At Nyprax, we […]
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 […]
The medical device and pharmaceutical industry is a vital part of global healthcare, generating over $500 billion annually and impacting millions of lives worldwide. From life-saving medications to innovative diagnostic tools, these products play a crucial role in patient care and treatment. Product registration is the process that allows these products to move from development […]
Medical device distribution in Singapore and Malaysia requires strict adherence to Good Distribution Practice for Medical Devices Standards (GDPMDS). These standards serve as crucial guidelines for maintaining product quality, safety, and efficacy throughout the supply chain. The regulatory landscape in both countries reflects their commitment to healthcare excellence: Singapore enforces GDPMDS through the Health Sciences […]