GDPMDS certification ensures safe, compliant medical device distribution, protecting quality and patient safety.
What Is Independent Licence Holding for Distributors? Understanding Legal Requirements and Business Benefits
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 […]
Top Challenges in Medical Device and Pharmaceutical Registration and How to Overcome Them
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 […]
How to Comply with GDPMDS Standards in Singapore & Malaysia
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 […]
Important Update on ASEAN Cosmetic Directive Amendments
Dear Cosmetic Products Dealers, During the 39th ASEAN Cosmetic Committee (ACC) meeting held on 20-21 May 2024, the ACC approved the ASEAN Cosmetic Scientific Body’s proposed updates to the Annexes of the ASEAN Cosmetic Directive (ACD). These updates are intended to ensure the safety of cosmetic products […]
HSA announces fee increase for Health Products
Singapore, 2 July 2024 – The Health Sciences Authority (HSA) is responsible for regulating health products to ensure they meet the required standards of quality, safety, and efficacy. To support this mission, various fees are in place for the registration, licensing, notification, and permit issuance for therapeutic products, medical devices, Chinese proprietary medicines, cosmetic products, […]