Welcome to Fusion Medivice Consultancy Sdn Bnd

Our Services

Complete Registration of Medical Devices with MDA from Risk Classes ranging from Class A to D

Class A (Low Risk)

Examples: Surgical retractors / tongue depressors

Class B (Low-moderate Risk)

Examples: Hypodermic needle / suction equipment

Class C (Moderate-high Risk)

Examples: Lung ventilator / orthopaedic implants

Class D (High Risk)

Examples: Heart valves / implantable defibrillator

Why Choose Us

Our pricings are competitive with the market rate and are negotiable.

Grit, Honesty, integrity and always opened to feedback from customers.

About Our Company

Led by a graduate of National University of Singapore (NUS), who has many years of experiences in handling Malaysia medical device regulatory affairs since compulsory MDA registration started in 2014/2015. Back then, single-handedly helped his company submit registration applications for all product portfolio in Malaysia (estimated 50 to 100 devices) before the tight deadline. Since then, he has worked in a medical device factory and his last position was heading regional regulatory affairs in a medical device MNC (including being in charge of ~60 MDA licenses).


Contact us for pricing and any further discussions