Compliance & Certification
At MedFix Sdn Bhd, regulatory compliance and quality assurance are fundamental to our operations. We are committed to meeting all applicable medical device regulations and industry standards to ensure the safety, reliability, and traceability of the products we supply.
Our compliance framework is aligned with both Malaysian regulatory requirements and internationally recognized standards, providing confidence to healthcare professionals and institutions in every product and service we deliver.
Our compliance framework is aligned with both Malaysian regulatory requirements and internationally recognized standards, providing confidence to healthcare professionals and institutions in every product and service we deliver.
Medical Device Authority (MDA) – Malaysia (Act 737)
We operate in full accordance with the Medical Device Act 2012 (Act 737), ensuring that all medical devices are properly registered, compliant, and legally distributed within Malaysia.
ISO 13485 – Quality Management System
Our processes align with ISO 13485 standards, ensuring consistent quality management in the handling, distribution, and control of medical devices.
Good Distribution Practice for Medical Devices (GDPMD)
We adhere to GDPMD guidelines to maintain the integrity, safety, and traceability of medical devices throughout the supply chain.
International Standards & Best Practices
Where applicable, our products meet internationally recognized standards such as CE marking and other global regulatory requirements, ensuring high levels of quality and performance.